Trial Outcomes & Findings for Gaining Optimism After Weight Loss Surgery (GOALS) II (NCT NCT04868032)
NCT ID: NCT04868032
Last Updated: 2026-03-27
Results Overview
After each of the 10 weekly intervention sessions, participants will rate that week's PP and goal-setting topics on how easy they were to complete and how helpful they were. Ratings will be measured on a 10-point Likert scale (1=very difficult/not at all helpful, 10=very easy/very helpful). Ratings for each category (e.g., ease of PP exercises) will be averaged across the 10 sessions to calculate a single value for that participant. The intervention will be considered acceptable if average ease and utility ratings are at least 7/10.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
58 participants
Primary outcome timeframe
10 weeks
Results posted on
2026-03-27
Participant Flow
Participant milestones
| Measure |
Positive Psychology-Motivational Interviewing Intervention
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
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|---|---|---|
|
Overall Study
STARTED
|
29
|
29
|
|
Overall Study
10 Week Follow Up
|
28
|
26
|
|
Overall Study
COMPLETED
|
26
|
25
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Positive Psychology-Motivational Interviewing Intervention
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
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|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Gaining Optimism After Weight Loss Surgery (GOALS) II
Baseline characteristics by cohort
| Measure |
Positive Psychology-Motivational Interviewing Intervention
n=29 Participants
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
n=29 Participants
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.59 years
STANDARD_DEVIATION 13.10 • n=56 Participants
|
43.34 years
STANDARD_DEVIATION 10.14 • n=62 Participants
|
44.47 years
STANDARD_DEVIATION 11.67 • n=123 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=56 Participants
|
24 Participants
n=62 Participants
|
51 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=56 Participants
|
5 Participants
n=62 Participants
|
7 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=56 Participants
|
5 Participants
n=62 Participants
|
11 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=56 Participants
|
24 Participants
n=62 Participants
|
47 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=56 Participants
|
5 Participants
n=62 Participants
|
15 Participants
n=123 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=56 Participants
|
20 Participants
n=62 Participants
|
35 Participants
n=123 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=56 Participants
|
1 Participants
n=62 Participants
|
3 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=56 Participants
|
3 Participants
n=62 Participants
|
5 Participants
n=123 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=56 Participants
|
29 Participants
n=62 Participants
|
58 Participants
n=123 Participants
|
PRIMARY outcome
Timeframe: 10 weeksFeasibility will be measured by examining the number of completed intervention sessions for individuals randomized to the PP-MI intervention. The intervention will be considered feasible if at least 7/10 sessions are completed, on average.
Outcome measures
| Measure |
Positive Psychology-Motivational Interviewing Intervention
n=29 Participants
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
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|---|---|---|
|
Number of Intervention Sessions Completed
|
9.6 Sessions completed
Standard Deviation 1.5
|
—
|
PRIMARY outcome
Timeframe: 10 weeksAfter each of the 10 weekly intervention sessions, participants will rate that week's PP and goal-setting topics on how easy they were to complete and how helpful they were. Ratings will be measured on a 10-point Likert scale (1=very difficult/not at all helpful, 10=very easy/very helpful). Ratings for each category (e.g., ease of PP exercises) will be averaged across the 10 sessions to calculate a single value for that participant. The intervention will be considered acceptable if average ease and utility ratings are at least 7/10.
Outcome measures
| Measure |
Positive Psychology-Motivational Interviewing Intervention
n=29 Participants
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
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|---|---|---|
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Intervention Acceptability
PP Topics Ease
|
8.5 Scores on a scale
Standard Deviation 1.7
|
—
|
|
Intervention Acceptability
PP Topics Utility
|
8.9 Scores on a scale
Standard Deviation 1.5
|
—
|
|
Intervention Acceptability
Goal Setting Topics Ease
|
8.6 Scores on a scale
Standard Deviation 1.6
|
—
|
|
Intervention Acceptability
Goal Setting Topics Utility
|
9.0 Scores on a scale
Standard Deviation 1.4
|
—
|
SECONDARY outcome
Timeframe: Baseline, 10-Week Follow-Up, 24-Week Follow-UpPopulation: Number analyzed reflects the number of participants who provided data at the corresponding time point.
We will use ActiGraph GT3X-BT accelerometers to objectively measure physical activity for 1 week at each assessment. MVPA will be measured in minutes/week.
Outcome measures
| Measure |
Positive Psychology-Motivational Interviewing Intervention
n=29 Participants
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
n=29 Participants
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
|
|---|---|---|
|
Change in Moderate to Vigorous Physical Activity (MVPA)
Baseline
|
109.47 minutes/week
Standard Deviation 63.94
|
110.33 minutes/week
Standard Deviation 105.35
|
|
Change in Moderate to Vigorous Physical Activity (MVPA)
10-Week Follow-Up
|
113.05 minutes/week
Standard Deviation 69.17
|
103.46 minutes/week
Standard Deviation 79.96
|
|
Change in Moderate to Vigorous Physical Activity (MVPA)
24-Week Follow-Up
|
125.75 minutes/week
Standard Deviation 83.91
|
93.09 minutes/week
Standard Deviation 87.83
|
SECONDARY outcome
Timeframe: Baseline, 10-Week Follow-Up, 24-Week Follow-UpPopulation: Number analyzed reflects the number of participants who provided data at the corresponding time point.
Measured by Actigraph accelerometer, in number of steps per day.
Outcome measures
| Measure |
Positive Psychology-Motivational Interviewing Intervention
n=29 Participants
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
n=29 Participants
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
|
|---|---|---|
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Change in Steps
Baseline
|
5180.53 steps/day
Standard Deviation 1722.06
|
4782.07 steps/day
Standard Deviation 1904.76
|
|
Change in Steps
10-Week Follow-Up
|
5219.74 steps/day
Standard Deviation 2040.10
|
4849.27 steps/day
Standard Deviation 1961.18
|
|
Change in Steps
24-Week Follow-Up
|
5306.91 steps/day
Standard Deviation 1622.68
|
4572.32 steps/day
Standard Deviation 1871.07
|
SECONDARY outcome
Timeframe: Baseline, 10-Week Follow-Up, 24-Week Follow-UpPopulation: Number analyzed reflects the number of participants who provided data at the corresponding time point.
Measured by Actigraph accelerometer, in minutes per day.
Outcome measures
| Measure |
Positive Psychology-Motivational Interviewing Intervention
n=29 Participants
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
n=29 Participants
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
|
|---|---|---|
|
Change in Light Physical Activity
24-Week Follow-Up
|
245.69 minutes/day
Standard Deviation 64.16
|
234.66 minutes/day
Standard Deviation 62.81
|
|
Change in Light Physical Activity
Baseline
|
253.28 minutes/day
Standard Deviation 68.57
|
230.44 minutes/day
Standard Deviation 73.03
|
|
Change in Light Physical Activity
10-Week Follow-Up
|
253.86 minutes/day
Standard Deviation 74.87
|
232.11 minutes/day
Standard Deviation 77.03
|
SECONDARY outcome
Timeframe: Baseline, 10-Week Follow-Up, 24-Week Follow-UpPopulation: Number analyzed reflects the number of participants who provided data at the corresponding time point.
The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect (Range: 10-50). Higher scores indicate higher levels of positive affect.
Outcome measures
| Measure |
Positive Psychology-Motivational Interviewing Intervention
n=29 Participants
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
n=29 Participants
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
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|---|---|---|
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Change in Positive Affect
Baseline
|
34.90 score on a scale
Standard Deviation 7.44
|
28.28 score on a scale
Standard Deviation 5.71
|
|
Change in Positive Affect
10-Week Follow-Up
|
38.38 score on a scale
Standard Deviation 7.36
|
30.96 score on a scale
Standard Deviation 7.17
|
|
Change in Positive Affect
24-Week Follow-Up
|
36.27 score on a scale
Standard Deviation 9.30
|
32.15 score on a scale
Standard Deviation 6.10
|
SECONDARY outcome
Timeframe: Baseline, 10-Week Follow-Up, 24-Week Follow-UpPopulation: Number analyzed reflects the number of participants who provided data at the corresponding time point.
The Life Orientation Test-Revised (LOT-R) is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Higher scores indicate higher levels of optimism.
Outcome measures
| Measure |
Positive Psychology-Motivational Interviewing Intervention
n=29 Participants
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
n=29 Participants
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
|
|---|---|---|
|
Change in Optimism
Baseline
|
10.28 score on a scale
Standard Deviation 3.63
|
11.59 score on a scale
Standard Deviation 2.77
|
|
Change in Optimism
10-Week Follow-Up
|
10.07 score on a scale
Standard Deviation 2.56
|
11.73 score on a scale
Standard Deviation 2.99
|
|
Change in Optimism
24-Week Follow-Up
|
10.69 score on a scale
Standard Deviation 3.03
|
11.24 score on a scale
Standard Deviation 2.39
|
SECONDARY outcome
Timeframe: Baseline, 10-Week Follow-Up, 24-Week Follow-UpPopulation: Number analyzed reflects the number of participants who provided data at the corresponding time point.
The Hospital Anxiety and Depression Scale (HADS)-depression subscale will be used to measure depression. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Higher scores indicate higher levels of depression.
Outcome measures
| Measure |
Positive Psychology-Motivational Interviewing Intervention
n=29 Participants
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
n=29 Participants
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
|
|---|---|---|
|
Change in Depressive Symptoms
Baseline
|
3.34 score on a scale
Standard Deviation 2.81
|
5.14 score on a scale
Standard Deviation 3.46
|
|
Change in Depressive Symptoms
10-Week Follow-Up
|
2.67 score on a scale
Standard Deviation 3.08
|
4.19 score on a scale
Standard Deviation 3.32
|
|
Change in Depressive Symptoms
24-Week Follow-Ip
|
3.42 score on a scale
Standard Deviation 3.60
|
4.08 score on a scale
Standard Deviation 3.19
|
SECONDARY outcome
Timeframe: Baseline, 10-Week Follow-Up, 24-Week Follow-UpPopulation: Number analyzed reflects the number of participants who provided data at the corresponding time point.
The Hospital Anxiety and Depression Scale (HADS)-anxiety subscale will be used to measure anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Higher scores indicate higher levels of anxiety.
Outcome measures
| Measure |
Positive Psychology-Motivational Interviewing Intervention
n=29 Participants
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
n=29 Participants
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
|
|---|---|---|
|
Change in Anxiety
Baseline
|
6.38 score on a scale
Standard Deviation 3.60
|
8 score on a scale
Standard Deviation 4.01
|
|
Change in Anxiety
10-Week Follow-Up
|
5.56 score on a scale
Standard Deviation 4.14
|
7.77 score on a scale
Standard Deviation 4.59
|
|
Change in Anxiety
24-Week Follow-Up
|
5.04 score on a scale
Standard Deviation 3.60
|
7.32 score on a scale
Standard Deviation 4.43
|
SECONDARY outcome
Timeframe: Baseline, 10-Week Follow-Up, 24-Week Follow-UpPopulation: Number analyzed reflects the number of participants who provided data at the corresponding time point.
The Exercise Identity Scale (EIS) is a well-validated, 9-item measure that will be used to assess exercise identity (Range: 9-63). Higher scores indicate stronger exercise identity.
Outcome measures
| Measure |
Positive Psychology-Motivational Interviewing Intervention
n=29 Participants
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
n=29 Participants
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
|
|---|---|---|
|
Change in Exercise Identity
Baseline
|
30.83 score on a scale
Standard Deviation 11.49
|
25.03 score on a scale
Standard Deviation 11.71
|
|
Change in Exercise Identity
10-Week Follow-Up
|
41.04 score on a scale
Standard Deviation 9.81
|
30.69 score on a scale
Standard Deviation 11.60
|
|
Change in Exercise Identity
24-Week Follow-Up
|
38.19 score on a scale
Standard Deviation 12.69
|
28.04 score on a scale
Standard Deviation 12.26
|
SECONDARY outcome
Timeframe: Baseline, 10-Week Follow-Up, 24-Week Follow-UpPopulation: Number analyzed reflects the number of participants who provided data at the corresponding time point.
Self-efficacy will be measured using the General Self Efficacy scale (GSE), a validated measure of self-efficacy, given its links to improved adherence. The range for total scores is 10-40 with higher scores indicate greater self-efficacy. Mean total scores are reported.
Outcome measures
| Measure |
Positive Psychology-Motivational Interviewing Intervention
n=29 Participants
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
n=29 Participants
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
|
|---|---|---|
|
Change in General Self-Efficacy
Baseline
|
32.55 score on a scale
Standard Deviation 4.66
|
31.76 score on a scale
Standard Deviation 3.92
|
|
Change in General Self-Efficacy
10-Week Follow-Up
|
34.00 score on a scale
Standard Deviation 5.15
|
32.00 score on a scale
Standard Deviation 3.37
|
|
Change in General Self-Efficacy
24-Week Follow-Up
|
33.65 score on a scale
Standard Deviation 5.18
|
31.52 score on a scale
Standard Deviation 5.06
|
SECONDARY outcome
Timeframe: Baseline, 10-Week Follow-Up, 24-Week Follow-UpPopulation: Number analyzed reflects the number of participants who provided data at the corresponding time point.
Exercise-specific self-efficacy will be measured by the Self-Efficacy for Exercise scale (SEE), a validated scale which assesses self-efficacy for exercise (Range: 0-90). Higher scores indicate higher self-efficacy.
Outcome measures
| Measure |
Positive Psychology-Motivational Interviewing Intervention
n=29 Participants
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
n=29 Participants
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
|
|---|---|---|
|
Change in Exercise-specific Self-efficacy
Baseline
|
46.52 score on a scale
Standard Deviation 17.21
|
45.63 score on a scale
Standard Deviation 18.56
|
|
Change in Exercise-specific Self-efficacy
10-Week Follow-Up
|
57.56 score on a scale
Standard Deviation 20.27
|
37.00 score on a scale
Standard Deviation 18.46
|
|
Change in Exercise-specific Self-efficacy
24-Week Follow-Up
|
50.08 score on a scale
Standard Deviation 21.66
|
36.96 score on a scale
Standard Deviation 18.66
|
SECONDARY outcome
Timeframe: Baseline, 10-Week Follow-Up, 24-Week Follow-UpPopulation: Number analyzed reflects the number of participants who provided data at the corresponding time point.
The Weight Bias Internalization Scale - Modified (WBIS-M) is a well-validated, 11-item measure that will be used to measure internalized weight bias (Range: 1-7). Higher scores indicate greater internalized weight bias.
Outcome measures
| Measure |
Positive Psychology-Motivational Interviewing Intervention
n=29 Participants
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
n=29 Participants
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
|
|---|---|---|
|
Change in Internalized Weight Bias
10-Week Follow-Up
|
2.89 score on a scale
Standard Deviation 1.11
|
3.33 score on a scale
Standard Deviation 1.46
|
|
Change in Internalized Weight Bias
Baseline
|
3.33 score on a scale
Standard Deviation 1.18
|
3.56 score on a scale
Standard Deviation 1.47
|
|
Change in Internalized Weight Bias
24-Week Follow-Up
|
2.58 score on a scale
Standard Deviation 1.29
|
3.13 score on a scale
Standard Deviation 1.57
|
SECONDARY outcome
Timeframe: Baseline, 10-Week Follow-Up, 24-Week Follow-UpPopulation: Number analyzed reflects the number of participants who provided data at the corresponding time point.
The Bariatric Surgery Self-Management Questionnaire (BSSQ) is a validated measure that will be used to assess adherence to diet and vitamin recommendations after bariatric surgery. The range of scores is 0-66 with higher scores indicating better adherence to diet and vitamin recommendations. Mean total scores are reported.
Outcome measures
| Measure |
Positive Psychology-Motivational Interviewing Intervention
n=29 Participants
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
n=29 Participants
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
|
|---|---|---|
|
Change in Bariatric Surgery-specific Diet and Vitamin Adherence
Baseline
|
44.59 score on a scale
Standard Deviation 6.91
|
41.90 score on a scale
Standard Deviation 8.01
|
|
Change in Bariatric Surgery-specific Diet and Vitamin Adherence
10-Week Follow-Up
|
49.44 score on a scale
Standard Deviation 6.72
|
42.00 score on a scale
Standard Deviation 9.02
|
|
Change in Bariatric Surgery-specific Diet and Vitamin Adherence
24-Week Follow-Up
|
47.96 score on a scale
Standard Deviation 7.56
|
41.04 score on a scale
Standard Deviation 7.63
|
SECONDARY outcome
Timeframe: Baseline, 10-Week Follow-Up, 24-Week Follow-UpPopulation: Number analyzed reflects the number of participants who provided data at the corresponding time point.
The International Physical Activity Questionnaire (IPAQ) - Short Form is a well-validated 7-day physical activity recall assessment for physical activity. Activity will be measured by the number of MET-minutes of moderate or greater activity per week.
Outcome measures
| Measure |
Positive Psychology-Motivational Interviewing Intervention
n=29 Participants
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
n=29 Participants
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
|
|---|---|---|
|
Change in Self-Reported Physical Activity
Baseline
|
1341.31 minutes/week
Standard Deviation 1534.06
|
771.83 minutes/week
Standard Deviation 935.74
|
|
Change in Self-Reported Physical Activity
10-Week Follow-Up
|
1719.82 minutes/week
Standard Deviation 1339.99
|
1424.11 minutes/week
Standard Deviation 1265.36
|
|
Change in Self-Reported Physical Activity
24-Week Follow-Up
|
2358.94 minutes/week
Standard Deviation 1955.57
|
1309.01 minutes/week
Standard Deviation 1454.25
|
SECONDARY outcome
Timeframe: Baseline, 10-Week Follow-Up, 24-Week Follow-UpPopulation: Number analyzed reflects the number of participants who provided data at the corresponding time point.
Body mass index (kilograms/meters squared) will be calculated with body weight and height measured on a calibrated scale.
Outcome measures
| Measure |
Positive Psychology-Motivational Interviewing Intervention
n=29 Participants
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
n=29 Participants
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
|
|---|---|---|
|
Change in Body Mass Index
Baseline
|
35.68 Unit of Measure (kg/m^2)
Standard Deviation 7.53
|
36.46 Unit of Measure (kg/m^2)
Standard Deviation 6.69
|
|
Change in Body Mass Index
10-Week Follow-Up
|
34.40 Unit of Measure (kg/m^2)
Standard Deviation 8.17
|
36.11 Unit of Measure (kg/m^2)
Standard Deviation 7.18
|
|
Change in Body Mass Index
24-Week Follow-Up
|
33.652 Unit of Measure (kg/m^2)
Standard Deviation 7.86
|
35.91 Unit of Measure (kg/m^2)
Standard Deviation 7.26
|
SECONDARY outcome
Timeframe: Baseline, 10-Week Follow-Up, 24-Week Follow-UpPopulation: Number analyzed reflects the number of participants who provided data at the corresponding time point.
Blood pressure will be measured by a nurse.
Outcome measures
| Measure |
Positive Psychology-Motivational Interviewing Intervention
n=29 Participants
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
n=29 Participants
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
|
|---|---|---|
|
Change in Systolic Blood Pressure (Millimeters of Mercury)
Baseline
|
121.24 millimeters of mercury (mm Hg)
Standard Deviation 12.43
|
116.55 millimeters of mercury (mm Hg)
Standard Deviation 17.22
|
|
Change in Systolic Blood Pressure (Millimeters of Mercury)
10-Week Follow-Up
|
123.20 millimeters of mercury (mm Hg)
Standard Deviation 13.21
|
119.21 millimeters of mercury (mm Hg)
Standard Deviation 12.13
|
|
Change in Systolic Blood Pressure (Millimeters of Mercury)
24-Week Follow-Up
|
121.75 millimeters of mercury (mm Hg)
Standard Deviation 13.46
|
120.64 millimeters of mercury (mm Hg)
Standard Deviation 13.18
|
SECONDARY outcome
Timeframe: Baseline, 10-Week Follow-Up, 24-Week Follow-UpPopulation: Number analyzed reflects the number of participants who provided data at the corresponding time point.
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Outcome measures
| Measure |
Positive Psychology-Motivational Interviewing Intervention
n=29 Participants
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
n=29 Participants
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
|
|---|---|---|
|
Change in Aerobic Capacity and Endurance
Baseline
|
477.20 meters
Standard Deviation 54.84
|
482.39 meters
Standard Deviation 57.04
|
|
Change in Aerobic Capacity and Endurance
10-Week Follow-Up
|
515.24 meters
Standard Deviation 80.34
|
507.68 meters
Standard Deviation 65.40
|
|
Change in Aerobic Capacity and Endurance
24-Week Follow-Up
|
511.41 meters
Standard Deviation 85.69
|
500.72 meters
Standard Deviation 60.62
|
SECONDARY outcome
Timeframe: Baseline, 10-Week Follow-Up, 24-Week Follow-UpPopulation: Number analyzed reflects the number of participants who provided data at the corresponding time point.
The measurement of body fat in relation to lean body mass will be measured using bio-electrical impedance.
Outcome measures
| Measure |
Positive Psychology-Motivational Interviewing Intervention
n=29 Participants
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
n=29 Participants
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
|
|---|---|---|
|
Change in Body Composition
24-Week Follow-Up
|
45.22 percentage of body fat
Standard Deviation 9.92
|
45.28 percentage of body fat
Standard Deviation 11.32
|
|
Change in Body Composition
Baseline
|
47.90 percentage of body fat
Standard Deviation 8.53
|
46.4 percentage of body fat
Standard Deviation 10.16
|
|
Change in Body Composition
10-Week Follow-Up
|
44.97 percentage of body fat
Standard Deviation 9.573
|
44.75 percentage of body fat
Standard Deviation 10.49
|
SECONDARY outcome
Timeframe: Baseline, 10-Week Follow-Up, 24-Week Follow-UpPopulation: Number analyzed reflects the number of participants who provided data at the corresponding time point.
Hemoglobin A1C will be measured via blood draw.
Outcome measures
| Measure |
Positive Psychology-Motivational Interviewing Intervention
n=29 Participants
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
n=29 Participants
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
|
|---|---|---|
|
Change in A1C
Baseline
|
5.45 percentage of glycated hemoglobin
Standard Deviation 0.76
|
5.19 percentage of glycated hemoglobin
Standard Deviation 0.41
|
|
Change in A1C
10-Week Follow-Up
|
5.43 percentage of glycated hemoglobin
Standard Deviation 0.59
|
5.27 percentage of glycated hemoglobin
Standard Deviation 0.47
|
|
Change in A1C
24-Week Follow-Up
|
5.38 percentage of glycated hemoglobin
Standard Deviation 0.51
|
5.36 percentage of glycated hemoglobin
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: Baseline, 10-Week Follow-Up, 24-Week Follow-UpPopulation: Number analyzed reflects the number of participants who provided data at the corresponding time point.
Lipids (HDL, LDL, Triglyceride) will be measured via blood draw.
Outcome measures
| Measure |
Positive Psychology-Motivational Interviewing Intervention
n=29 Participants
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
n=29 Participants
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
|
|---|---|---|
|
Change in HDL Cholesterol
Baseline
|
53.62 Milligrams (mg) per deciliter (dL)
Standard Deviation 14.18
|
52.28 Milligrams (mg) per deciliter (dL)
Standard Deviation 7.04
|
|
Change in HDL Cholesterol
10-Week Follow-Up
|
57.88 Milligrams (mg) per deciliter (dL)
Standard Deviation 15.89
|
56.30 Milligrams (mg) per deciliter (dL)
Standard Deviation 8.56
|
|
Change in HDL Cholesterol
24-Week Follow-Up
|
62.87 Milligrams (mg) per deciliter (dL)
Standard Deviation 19.02
|
57.88 Milligrams (mg) per deciliter (dL)
Standard Deviation 9.42
|
SECONDARY outcome
Timeframe: Baseline, 10-Week Follow-Up, 24-Week Follow-UpPopulation: Number analyzed reflects the number of participants who provided data at the corresponding time point.
C-reactive protein will be measured via blood draw as a measure of inflammation.
Outcome measures
| Measure |
Positive Psychology-Motivational Interviewing Intervention
n=29 Participants
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
n=29 Participants
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
|
|---|---|---|
|
Change in Inflammation
Baseline
|
4.11 Milligrams per deciliter (mg/dL)
Standard Deviation 3.45
|
3.80 Milligrams per deciliter (mg/dL)
Standard Deviation 3.19
|
|
Change in Inflammation
10-Week Follow-Up
|
2.71 Milligrams per deciliter (mg/dL)
Standard Deviation 2.72
|
2.55 Milligrams per deciliter (mg/dL)
Standard Deviation 2.32
|
|
Change in Inflammation
24-Week Follow-Up
|
3.07 Milligrams per deciliter (mg/dL)
Standard Deviation 2.95
|
2.86 Milligrams per deciliter (mg/dL)
Standard Deviation 3.07
|
SECONDARY outcome
Timeframe: Baseline, 10-Week Follow-Up, 24-Week Follow-UpPopulation: Number analyzed reflects the number of participants who provided data at the corresponding time point.
Self-efficacy will be measured using the Physical Activity Enjoyment Scale (PACES), a validated measure of enjoyment during exercise. The range of total scores is 18-126 with higher scores indicating greater enjoyment during exercise. Mean total scores are reported.
Outcome measures
| Measure |
Positive Psychology-Motivational Interviewing Intervention
n=29 Participants
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
n=29 Participants
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
|
|---|---|---|
|
Change in Physical Activity Enjoyment
Baseline
|
83.38 score on a scale
Standard Deviation 22.98
|
83 score on a scale
Standard Deviation 18.14
|
|
Change in Physical Activity Enjoyment
10-Week Follow-Up
|
96.85 score on a scale
Standard Deviation 17.43
|
89.21 score on a scale
Standard Deviation 17.86
|
|
Change in Physical Activity Enjoyment
24-Week Follow-Up
|
89.69 score on a scale
Standard Deviation 24.42
|
82.76 score on a scale
Standard Deviation 21.61
|
SECONDARY outcome
Timeframe: Baseline, 10-Week Follow-Up, 24-Week Follow-UpPopulation: Number analyzed reflects the number of participants who provided data at the corresponding time point.
Blood pressure will be measured by a nurse.
Outcome measures
| Measure |
Positive Psychology-Motivational Interviewing Intervention
n=29 Participants
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
n=29 Participants
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
|
|---|---|---|
|
Change in Diastolic Blood Pressure (Millimeters of Mercury)
Baseline
|
69.00 millimeters of mercury (mm Hg)
Standard Deviation 10.67
|
66.59 millimeters of mercury (mm Hg)
Standard Deviation 9.23
|
|
Change in Diastolic Blood Pressure (Millimeters of Mercury)
10-Week Follow-Up
|
69.12 millimeters of mercury (mm Hg)
Standard Deviation 11.16
|
71.58 millimeters of mercury (mm Hg)
Standard Deviation 9.71
|
|
Change in Diastolic Blood Pressure (Millimeters of Mercury)
24-Week Follow-Up
|
70.04 millimeters of mercury (mm Hg)
Standard Deviation 8.66
|
70.84 millimeters of mercury (mm Hg)
Standard Deviation 7.32
|
SECONDARY outcome
Timeframe: Baseline, 10-Week Follow-Up, 24-Week Follow-UpPopulation: Number analyzed reflects the number of participants who provided data at the corresponding time point.
Lipids (HDL, LDL, Triglyceride) will be measured via blood draw.
Outcome measures
| Measure |
Positive Psychology-Motivational Interviewing Intervention
n=29 Participants
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
n=29 Participants
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
|
|---|---|---|
|
Change in LDL Cholesterol
Baseline
|
105.28 Milligrams (mg) per deciliter (dL)
Standard Deviation 31.74
|
92.63 Milligrams (mg) per deciliter (dL)
Standard Deviation 25.89
|
|
Change in LDL Cholesterol
10-Week Follow-Up
|
103.96 Milligrams (mg) per deciliter (dL)
Standard Deviation 30.21
|
97.39 Milligrams (mg) per deciliter (dL)
Standard Deviation 36.45
|
|
Change in LDL Cholesterol
24-Week Follow-Up
|
104.96 Milligrams (mg) per deciliter (dL)
Standard Deviation 33.52
|
89.48 Milligrams (mg) per deciliter (dL)
Standard Deviation 30.93
|
SECONDARY outcome
Timeframe: Baseline, 10-Week Follow-Up, 24-Week Follow-UpPopulation: Number analyzed reflects the number of participants who provided data at the corresponding time point.
Lipids (HDL, LDL, Triglyceride) will be measured via blood draw.
Outcome measures
| Measure |
Positive Psychology-Motivational Interviewing Intervention
n=29 Participants
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
n=29 Participants
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
|
|---|---|---|
|
Change in Triglycerides
Baseline
|
102.93 Milligrams (mg) per deciliter (dL)
Standard Deviation 44.53
|
124.28 Milligrams (mg) per deciliter (dL)
Standard Deviation 102.72
|
|
Change in Triglycerides
10-Week Follow-Up
|
102.72 Milligrams (mg) per deciliter (dL)
Standard Deviation 55.46
|
113.61 Milligrams (mg) per deciliter (dL)
Standard Deviation 72.37
|
|
Change in Triglycerides
24-Week Follow-Up
|
91.13 Milligrams (mg) per deciliter (dL)
Standard Deviation 44.81
|
109.36 Milligrams (mg) per deciliter (dL)
Standard Deviation 57.21
|
Adverse Events
Positive Psychology-Motivational Interviewing Intervention
Serious events: 2 serious events
Other events: 1 other events
Deaths: 1 deaths
Physical Activity Education Control
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Positive Psychology-Motivational Interviewing Intervention
n=29 participants at risk
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
n=29 participants at risk
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain and constipation
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from enrollment until the end of follow-up, up to 32 weeks.
|
0.00%
0/29 • Adverse events were reported from enrollment until the end of follow-up, up to 32 weeks.
|
|
General disorders
Cancer
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from enrollment until the end of follow-up, up to 32 weeks.
|
0.00%
0/29 • Adverse events were reported from enrollment until the end of follow-up, up to 32 weeks.
|
Other adverse events
| Measure |
Positive Psychology-Motivational Interviewing Intervention
n=29 participants at risk
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
|
Physical Activity Education Control
n=29 participants at risk
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall, fracture
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from enrollment until the end of follow-up, up to 32 weeks.
|
0.00%
0/29 • Adverse events were reported from enrollment until the end of follow-up, up to 32 weeks.
|
|
Injury, poisoning and procedural complications
Muscle sprain, joint injury
|
0.00%
0/29 • Adverse events were reported from enrollment until the end of follow-up, up to 32 weeks.
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from enrollment until the end of follow-up, up to 32 weeks.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders (Other)
|
0.00%
0/29 • Adverse events were reported from enrollment until the end of follow-up, up to 32 weeks.
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from enrollment until the end of follow-up, up to 32 weeks.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/29 • Adverse events were reported from enrollment until the end of follow-up, up to 32 weeks.
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from enrollment until the end of follow-up, up to 32 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place