Trial Outcomes & Findings for A Psychological-behavioral Intervention to Increase Activity in Type 2 Diabetes (NCT NCT03164538)

NCT ID: NCT03164538

Last Updated: 2021-02-21

Results Overview

Measured by number of PP-MI sessions completed by participants in the PP-MI group.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

70 participants

Primary outcome timeframe

16 weeks

Results posted on

2021-02-21

Participant Flow

Participant milestones

Participant milestones
Measure
Positive Psychology + Motivational Interviewing
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions.
Diabetes Education
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
Overall Study
STARTED
35
35
Overall Study
COMPLETED
28
29
Overall Study
NOT COMPLETED
7
6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One participant did not complete this measure at baseline.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Positive Psychology + Motivational Interviewing
n=35 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions.
Diabetes Education
n=35 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
Total
n=70 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=35 Participants
0 Participants
n=35 Participants
0 Participants
n=70 Participants
Age, Categorical
Between 18 and 65 years
19 Participants
n=35 Participants
20 Participants
n=35 Participants
39 Participants
n=70 Participants
Age, Categorical
>=65 years
16 Participants
n=35 Participants
15 Participants
n=35 Participants
31 Participants
n=70 Participants
Age, Continuous
64.6 years
STANDARD_DEVIATION 10.2 • n=35 Participants
62.9 years
STANDARD_DEVIATION 10.7 • n=35 Participants
63.7 years
STANDARD_DEVIATION 10.4 • n=70 Participants
Sex: Female, Male
Female
16 Participants
n=35 Participants
16 Participants
n=35 Participants
32 Participants
n=70 Participants
Sex: Female, Male
Male
19 Participants
n=35 Participants
19 Participants
n=35 Participants
38 Participants
n=70 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=35 Participants
3 Participants
n=35 Participants
3 Participants
n=70 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
35 Participants
n=35 Participants
32 Participants
n=35 Participants
67 Participants
n=70 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=35 Participants
0 Participants
n=35 Participants
0 Participants
n=70 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=35 Participants
0 Participants
n=35 Participants
0 Participants
n=70 Participants
Race (NIH/OMB)
Asian
5 Participants
n=35 Participants
1 Participants
n=35 Participants
6 Participants
n=70 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=35 Participants
0 Participants
n=35 Participants
0 Participants
n=70 Participants
Race (NIH/OMB)
Black or African American
5 Participants
n=35 Participants
2 Participants
n=35 Participants
7 Participants
n=70 Participants
Race (NIH/OMB)
White
24 Participants
n=35 Participants
30 Participants
n=35 Participants
54 Participants
n=70 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=35 Participants
1 Participants
n=35 Participants
1 Participants
n=70 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=35 Participants
1 Participants
n=35 Participants
2 Participants
n=70 Participants
Moderate-Vigorous Physical Activity
13.66 minutes/day
STANDARD_DEVIATION 13.15 • n=35 Participants
13.67 minutes/day
STANDARD_DEVIATION 12.12 • n=35 Participants
13.66 minutes/day
STANDARD_DEVIATION 12.55 • n=70 Participants
Physical Activity
4706 steps/day
STANDARD_DEVIATION 2389 • n=35 Participants
4805 steps/day
STANDARD_DEVIATION 1993 • n=35 Participants
4756 steps/day
STANDARD_DEVIATION 2184 • n=70 Participants
Sedentary Time
551.40 minutes/day
STANDARD_DEVIATION 98.74 • n=35 Participants
499.66 minutes/day
STANDARD_DEVIATION 78.33 • n=35 Participants
525.53 minutes/day
STANDARD_DEVIATION 92.23 • n=70 Participants
Positive Affect
35.74 score on a scale
STANDARD_DEVIATION 6.87 • n=35 Participants
33.51 score on a scale
STANDARD_DEVIATION 7.54 • n=35 Participants
34.63 score on a scale
STANDARD_DEVIATION 7.25 • n=70 Participants
Optimism
15.94 score on a scale
STANDARD_DEVIATION 5.64 • n=35 Participants
17.20 score on a scale
STANDARD_DEVIATION 4.73 • n=35 Participants
16.57 score on a scale
STANDARD_DEVIATION 5.20 • n=70 Participants
Self-Efficacy for Exercise
50.06 score on a scale
STANDARD_DEVIATION 19.63 • n=35 Participants
55.43 score on a scale
STANDARD_DEVIATION 21.66 • n=35 Participants
52.74 score on a scale
STANDARD_DEVIATION 20.69 • n=70 Participants
Depression
3.63 score on a scale
STANDARD_DEVIATION 3.87 • n=35 Participants
4.00 score on a scale
STANDARD_DEVIATION 3.61 • n=35 Participants
3.81 score on a scale
STANDARD_DEVIATION 3.72 • n=70 Participants
Anxiety
5.37 score on a scale
STANDARD_DEVIATION 4.16 • n=35 Participants
5.60 score on a scale
STANDARD_DEVIATION 4.31 • n=35 Participants
5.49 score on a scale
STANDARD_DEVIATION 4.21 • n=70 Participants
Resilience
17.86 score on a scale
STANDARD_DEVIATION 2.32 • n=35 Participants
18.06 score on a scale
STANDARD_DEVIATION 1.63 • n=35 Participants
17.96 score on a scale
STANDARD_DEVIATION 1.99 • n=70 Participants
Perceived Social Support (MSPSS)
64.06 score on a scale
STANDARD_DEVIATION 18.25 • n=35 Participants
63.14 score on a scale
STANDARD_DEVIATION 18.25 • n=35 Participants
63.60 score on a scale
STANDARD_DEVIATION 18.12 • n=70 Participants
Diabetes Self-Care
3.17 score on a scale
STANDARD_DEVIATION 1.02 • n=35 Participants
2.27 score on a scale
STANDARD_DEVIATION 1.09 • n=35 Participants
2.72 score on a scale
STANDARD_DEVIATION 1.14 • n=70 Participants
Medication Adherence
91 percentage of medication taken
STANDARD_DEVIATION 22 • n=35 Participants
93 percentage of medication taken
STANDARD_DEVIATION 14 • n=35 Participants
92 percentage of medication taken
STANDARD_DEVIATION 18 • n=70 Participants
Self-Reported Physical Activity
633.82 MET minutes per week
STANDARD_DEVIATION 560.97 • n=35 Participants
1914.87 MET minutes per week
STANDARD_DEVIATION 4374.98 • n=35 Participants
1274.34 MET minutes per week
STANDARD_DEVIATION 3162.72 • n=70 Participants
Physical Function
92.77 score on a scale
STANDARD_DEVIATION 5.50 • n=35 Participants
90.31 score on a scale
STANDARD_DEVIATION 10.92 • n=35 Participants
91.54 score on a scale
STANDARD_DEVIATION 8.67 • n=70 Participants
Pain-Related Disability
8.77 score on a scale
STANDARD_DEVIATION 10.36 • n=35 Participants • One participant did not complete this measure at baseline.
13.71 score on a scale
STANDARD_DEVIATION 15.15 • n=34 Participants • One participant did not complete this measure at baseline.
11.20 score on a scale
STANDARD_DEVIATION 13.09 • n=69 Participants • One participant did not complete this measure at baseline.
Weight
195.10 pounds
STANDARD_DEVIATION 34.02 • n=35 Participants
194.05 pounds
STANDARD_DEVIATION 40.85 • n=35 Participants
194.57 pounds
STANDARD_DEVIATION 37.32 • n=70 Participants
Body Mass Index (BMI)
30.98 kg/m^2
STANDARD_DEVIATION 4.47 • n=35 Participants
31.08 kg/m^2
STANDARD_DEVIATION 5.58 • n=35 Participants
31.03 kg/m^2
STANDARD_DEVIATION 5.02 • n=70 Participants
Blood Pressure (systolic)
139.63 millimeters of mercury
STANDARD_DEVIATION 11.31 • n=35 Participants
138.63 millimeters of mercury
STANDARD_DEVIATION 13.97 • n=35 Participants
139.13 millimeters of mercury
STANDARD_DEVIATION 12.63 • n=70 Participants
Blood Pressure (diastolic)
73.34 millimeters of mercury
STANDARD_DEVIATION 8.21 • n=35 Participants
74.09 millimeters of mercury
STANDARD_DEVIATION 9.37 • n=35 Participants
73.71 millimeters of mercury
STANDARD_DEVIATION 8.75 • n=70 Participants
Hemoglobin A1c
7.72 mg/dL
STANDARD_DEVIATION 1.66 • n=35 Participants
7.75 mg/dL
STANDARD_DEVIATION 1.56 • n=35 Participants
7.73 mg/dL
STANDARD_DEVIATION 1.60 • n=70 Participants

PRIMARY outcome

Timeframe: 16 weeks

Measured by number of PP-MI sessions completed by participants in the PP-MI group.

Outcome measures

Outcome measures
Measure
Diabetes Education
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
Positive Psychology + Motivational Interviewing
n=35 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions.
Number of PP-MI Sessions Completed by Participants
11 sessions completed
Standard Deviation 4.45

SECONDARY outcome

Timeframe: Weeks 1-16

Participants in the PP-MI group will provide ratings of ease after each PP exercise, measured on a 10-point Likert scale (0=very difficult; 10=very easy). Weekly ratings were averaged to provide an overall ease of the exercises.

Outcome measures

Outcome measures
Measure
Diabetes Education
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
Positive Psychology + Motivational Interviewing
n=35 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions.
Ease of PP Component
8.18 units on a scale
Standard Deviation 1.98

SECONDARY outcome

Timeframe: Weeks 1-16

Participants in the PP-MI group will provide ratings of ease after each MI exercise, measured on a 10-point Likert scale (0=very difficult; 10=very easy). Weekly ratings were averaged to provide an overall ease of the exercises.

Outcome measures

Outcome measures
Measure
Diabetes Education
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
Positive Psychology + Motivational Interviewing
n=35 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions.
Ease of MI Component
8.40 units on a scale
Standard Deviation 1.83

SECONDARY outcome

Timeframe: Weeks 1-16

Participants in the PP-MI group will provide ratings of utility after each PP exercise, measured on a 10-point Likert scale (0=not at all helpful; 10=very helpful). Weekly utility ratings were averaged to provide an overall utility score of the exercises.

Outcome measures

Outcome measures
Measure
Diabetes Education
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
Positive Psychology + Motivational Interviewing
n=35 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions.
Utility of PP Component
8.78 units on a scale
Standard Deviation 1.51

SECONDARY outcome

Timeframe: Weeks 1-16

Participants in the PP-MI group will provide ratings of utility after each MI exercise, measured on a 10-point Likert scale (0=not at all helpful; 10=very helpful). Weekly utility ratings were averaged to provide an overall utility score of the exercises.

Outcome measures

Outcome measures
Measure
Diabetes Education
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
Positive Psychology + Motivational Interviewing
n=35 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions.
Utility of MI Component
8.96 units on a scale
Standard Deviation 1.40

SECONDARY outcome

Timeframe: Change from Baseline to 16 weeks, and Baseline to 24 weeks

Population: Not all participants wore the Actigraph and provided adequate data at both follow-up time points.

ActiGraph GT3X+ step counters are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer for one week at baseline, 16 weeks, and 24 weeks to assess the feasibility of doing so and to ensure adequate capture of physical activity.

Outcome measures

Outcome measures
Measure
Diabetes Education
n=35 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
Positive Psychology + Motivational Interviewing
n=35 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions.
Change in Moderate-Vigorous Physical Activity
16 weeks
-1.21 minutes/day
Standard Deviation 9.76
3.88 minutes/day
Standard Deviation 10.98
Change in Moderate-Vigorous Physical Activity
24 weeks
0.33 minutes/day
Standard Deviation 12.09
2.75 minutes/day
Standard Deviation 10.31

SECONDARY outcome

Timeframe: Change from Baseline to 16 weeks, and Baseline to 24 weeks

Population: Not all participants wore the Actigraph and provided adequate data.

Measured by Actigraph accelerometer, in number of steps per day.

Outcome measures

Outcome measures
Measure
Diabetes Education
n=27 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
Positive Psychology + Motivational Interviewing
n=25 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions.
Change in Physical Activity
16 weeks
-379 steps/day
Standard Deviation 1228
904 steps/day
Standard Deviation 1206
Change in Physical Activity
24 weeks
-290 steps/day
Standard Deviation 1301
222 steps/day
Standard Deviation 1410

SECONDARY outcome

Timeframe: Change from Baseline to 16 weeks, and Baseline to 24 weeks

Population: Not all participants wore the Actigraph and provided adequate data.

Measured by Actigraph accelerometer, in minutes per day.

Outcome measures

Outcome measures
Measure
Diabetes Education
n=27 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
Positive Psychology + Motivational Interviewing
n=25 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions.
Change in Sedentary Time
16 weeks
5.78 minutes/day
Standard Deviation 74.75
19.68 minutes/day
Standard Deviation 138.82
Change in Sedentary Time
24 weeks
4.74 minutes/day
Standard Deviation 79.95
-11.84 minutes/day
Standard Deviation 84.61

SECONDARY outcome

Timeframe: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks

Population: Not all participants completed follow-up questionnaires at both follow-up time points.

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). Change was calculated by subtracting the score at baseline from the score at 16 and 24 weeks. Higher scores indicate higher levels of positive affect.

Outcome measures

Outcome measures
Measure
Diabetes Education
n=29 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
Positive Psychology + Motivational Interviewing
n=28 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions.
Change in Positive Affect
16 weeks
0.41 score on a scale
Standard Deviation 5.13
1.29 score on a scale
Standard Deviation 5.68
Change in Positive Affect
24 weeks
4.21 score on a scale
Standard Deviation 6.65
5.54 score on a scale
Standard Deviation 6.09

SECONDARY outcome

Timeframe: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks

Population: Not all participants completed follow-up questionnaires at both follow-up time points.

Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Change was calculated by subtracting the score at baseline from the score at 16 and 24 weeks. Higher scores indicate higher levels of optimism.

Outcome measures

Outcome measures
Measure
Diabetes Education
n=29 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
Positive Psychology + Motivational Interviewing
n=28 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions.
Change in Optimism
16 weeks
0.55 score on a scale
Standard Deviation 3.16
2.54 score on a scale
Standard Deviation 4.38
Change in Optimism
24 weeks
0.43 score on a scale
Standard Deviation 4.86
2.54 score on a scale
Standard Deviation 3.79

SECONDARY outcome

Timeframe: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks

Population: Not all participants completed follow-up questionnaires at both follow-up time points.

Measured by the Self-Efficacy for Exercise scale (SEE), a validated scale which assess self-efficacy barriers to exercise (Range: 0-90). Higher scores indicate higher efficacy expectations in relation to exercising. This was measured at Baseline, Week 16, and Week 24.

Outcome measures

Outcome measures
Measure
Diabetes Education
n=29 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
Positive Psychology + Motivational Interviewing
n=28 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions.
Change in Self-Efficacy for Exercise
24 weeks
-7.81 score on a scale
Standard Deviation 27.47
7.38 score on a scale
Standard Deviation 21.97
Change in Self-Efficacy for Exercise
16 weeks
-9.55 score on a scale
Standard Deviation 25.75
12.50 score on a scale
Standard Deviation 22.66

SECONDARY outcome

Timeframe: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks

Population: Not all participants completed follow-up questionnaires at both follow-up time points.

The Hospital Anxiety and Depression Scale (HADS)-depression subscale was 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). Change was calculated by subtracting the score at baseline from the score at 16 and 24 weeks. Higher scores indicate higher levels of depression.

Outcome measures

Outcome measures
Measure
Diabetes Education
n=29 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
Positive Psychology + Motivational Interviewing
n=28 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions.
Change in Depression
16 weeks
-0.72 score on a scale
Standard Deviation 1.87
-0.11 score on a scale
Standard Deviation 3.19
Change in Depression
24 weeks
0.46 score on a scale
Standard Deviation 2.62
0.00 score on a scale
Standard Deviation 3.02

SECONDARY outcome

Timeframe: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks

Population: Not all participants completed follow-up questionnaires at both follow-up time points.

The Hospital Anxiety and Depression Scale (HADS)-anxiety subscale was 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). Change was calculated by subtracting the score at baseline from the score at 16 and 24 weeks. Higher scores indicate higher levels of anxiety.

Outcome measures

Outcome measures
Measure
Diabetes Education
n=29 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
Positive Psychology + Motivational Interviewing
n=28 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions.
Change in Anxiety
16 weeks
-0.90 score on a scale
Standard Deviation 2.23
-1.04 score on a scale
Standard Deviation 3.98
Change in Anxiety
24 weeks
-0.96 score on a scale
Standard Deviation 3.20
-1.00 score on a scale
Standard Deviation 3.44

SECONDARY outcome

Timeframe: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks

Population: Not all participants completed follow-up questionnaires at both follow-up time points.

Measured by the Brief Resilience Scale (BRS), a reliable scale which assesses a person's ability to recover from stress despite adversity (Range: 6-30). Higher scores indicate more resilience.

Outcome measures

Outcome measures
Measure
Diabetes Education
n=29 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
Positive Psychology + Motivational Interviewing
n=28 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions.
Change in Resilience
16 weeks
0.00 score on a scale
Standard Deviation 2.33
-0.07 score on a scale
Standard Deviation 3.95
Change in Resilience
24 weeks
0.64 score on a scale
Standard Deviation 2.33
-0.25 score on a scale
Standard Deviation 2.64

SECONDARY outcome

Timeframe: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks

Population: Not all participants completed follow-up questionnaires at both follow-up time points.

Measured by the Multidimensional Scale of Perceived Social Support (MSPSS), a scale that measures subjectively reported social support (Range: 12-84). Higher scores indicate more subjectively reported social support.

Outcome measures

Outcome measures
Measure
Diabetes Education
n=29 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
Positive Psychology + Motivational Interviewing
n=28 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions.
Change in Perceived Social Support
16 weeks
3.83 score on a scale
Standard Deviation 12.62
-1.18 score on a scale
Standard Deviation 19.88
Change in Perceived Social Support
24 weeks
5.57 score on a scale
Standard Deviation 15.15
6.25 score on a scale
Standard Deviation 14.86

SECONDARY outcome

Timeframe: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks

Population: Not all participants completed all follow-up questionnaires at both follow-up time points.

Measured by the Summary of Diabetes Self-Care Activities (SDSCA), a well-validated measure of diabetes self-management that is associated with clinical outcomes (Range: 0-7). Higher scores indicate more diabetes self-care activities.

Outcome measures

Outcome measures
Measure
Diabetes Education
n=29 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
Positive Psychology + Motivational Interviewing
n=28 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions.
Change in Diabetes Self-Care
16 weeks
1.02 score on a scale
Standard Deviation 1.03
0.79 score on a scale
Standard Deviation 0.93
Change in Diabetes Self-Care
24 weeks
1.13 score on a scale
Standard Deviation 1.20
0.97 score on a scale
Standard Deviation 0.92

OTHER_PRE_SPECIFIED outcome

Timeframe: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks

Population: Not all participants completed follow-up questionnaires at both follow-up time points.

Measured by Self-Reported Medication Adherence (SRMA), a two-item self-report medication adherence scale measuring percentage of time (in 10% increments) patients report taking their heart medications in the past one and two weeks. Minimum: 0, Maximum:100. Change was calculated by subtracting the score at baseline from the score at 16 weeks and 24 weeks. Higher scores indicate greater levels of medication adherence.

Outcome measures

Outcome measures
Measure
Diabetes Education
n=29 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
Positive Psychology + Motivational Interviewing
n=28 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions.
Change in Medication Adherence
16 weeks
0.3 percentage of medication taken
Standard Deviation 7.8
0.7 percentage of medication taken
Standard Deviation 5.4
Change in Medication Adherence
24 weeks
-0.4 percentage of medication taken
Standard Deviation 10.7
2.1 percentage of medication taken
Standard Deviation 4.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks

Population: Not all participants completed all follow-up questionnaires at both follow-up time points.

Measured by the self-report International Physical Activity Questionnaire (IPAQ). The measure assesses the types of intensity of physical activity that people do as part of their daily lives. All activities are converted to multiples of resting energy expenditure (MET) minutes per week. Change was calculated by subtracting the score at baseline from the score at 16 and 24 weeks.

Outcome measures

Outcome measures
Measure
Diabetes Education
n=28 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
Positive Psychology + Motivational Interviewing
n=28 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions.
Change in Self-Reported Physical Activity
16 weeks
96.10 MET minutes per week
Standard Deviation 1704.43
1512.41 MET minutes per week
Standard Deviation 1957.69
Change in Self-Reported Physical Activity
24 weeks
-87.80 MET minutes per week
Standard Deviation 1585.93
912.72 MET minutes per week
Standard Deviation 1096.29

OTHER_PRE_SPECIFIED outcome

Timeframe: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks

Population: Not all participants completed follow-up questionnaires at both follow-up time points.

Measured by the 20-item short form of the Patient-Reported Outcomes Measurement Information System (PROMIS), a well-validated measure of physical function that is highly responsive to changes in a patient's physical function status (Range: 20-100). Higher scores indicate better physical function.

Outcome measures

Outcome measures
Measure
Diabetes Education
n=29 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
Positive Psychology + Motivational Interviewing
n=28 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions.
Change in Physical Function
16 weeks
0.31 score on a scale
Standard Deviation 4.42
0.04 score on a scale
Standard Deviation 5.72
Change in Physical Function
24 weeks
0.96 score on a scale
Standard Deviation 5.27
2.83 score on a scale
Standard Deviation 4.67

OTHER_PRE_SPECIFIED outcome

Timeframe: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks

Population: Not all participants completed follow-up questionnaires at both follow-up time points.

Measured by the Pain Disability Index (PDI), a well-validated measure of the extent to which pain interferes with different daily activities (Range 0-70). Higher scores indicate greater interference from pain.

Outcome measures

Outcome measures
Measure
Diabetes Education
n=28 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
Positive Psychology + Motivational Interviewing
n=28 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions.
Change in Pain-Related Disability
16 weeks
-5.18 score on a scale
Standard Deviation 10.50
1.11 score on a scale
Standard Deviation 13.68
Change in Pain-Related Disability
24 weeks
-1.22 score on a scale
Standard Deviation 13.65
-2.83 score on a scale
Standard Deviation 9.18

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from Baseline to Week 16

Measured during in-person visit at baseline and post-intervention.

Outcome measures

Outcome measures
Measure
Diabetes Education
n=26 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
Positive Psychology + Motivational Interviewing
n=28 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions.
Change in Weight
0.09 pounds
Standard Deviation 4.88
-2.08 pounds
Standard Deviation 5.68

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from Baseline to Week 16

Measured during in-person visit at baseline and post-intervention.

Outcome measures

Outcome measures
Measure
Diabetes Education
n=26 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
Positive Psychology + Motivational Interviewing
n=27 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions.
Change in Body Mass Index (BMI)
0.00 kg/m^2
Standard Deviation 0.73
-0.28 kg/m^2
Standard Deviation 1.11

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from Baseline to Week 16

Measured during in-person visit at baseline and post-intervention.

Outcome measures

Outcome measures
Measure
Diabetes Education
n=25 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
Positive Psychology + Motivational Interviewing
n=27 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions.
Change in Blood Pressure (Systolic)
-1.08 millimeters of mercury
Standard Deviation 17.21
-5.52 millimeters of mercury
Standard Deviation 15.99

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from Baseline to Week 16

Measured during in-person visit at baseline and post-intervention.

Outcome measures

Outcome measures
Measure
Diabetes Education
n=25 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
Positive Psychology + Motivational Interviewing
n=27 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions.
Change in Blood Pressure (Diastolic)
-0.36 millimeters of mercury
Standard Deviation 11.28
-3.00 millimeters of mercury
Standard Deviation 7.76

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from Baseline to Week 16

Measured during in-person visit at baseline and post-intervention.

Outcome measures

Outcome measures
Measure
Diabetes Education
n=26 Participants
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
Positive Psychology + Motivational Interviewing
n=28 Participants
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions.
Change in Hemoglobin A1c
0.10 mg/dL
Standard Deviation 0.44
0.10 mg/dL
Standard Deviation 1.09

Adverse Events

Positive Psychology + Motivational Interviewing

Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths

Diabetes Education

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Positive Psychology + Motivational Interviewing
n=35 participants at risk
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions.
Diabetes Education
n=35 participants at risk
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
Infections and infestations
Leg infection
2.9%
1/35 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
0.00%
0/35 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
Cardiac disorders
Unexpected Atrial Fibrillation
5.7%
2/35 • Number of events 2 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
0.00%
0/35 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
Respiratory, thoracic and mediastinal disorders
Unexpected acute respiratory failure
2.9%
1/35 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
0.00%
0/35 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."

Other adverse events

Other adverse events
Measure
Positive Psychology + Motivational Interviewing
n=35 participants at risk
Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions.
Diabetes Education
n=35 participants at risk
Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
Endocrine disorders
Unexpected hypoglycemia
2.9%
1/35 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
5.7%
2/35 • Number of events 4 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
Injury, poisoning and procedural complications
Cat bite
2.9%
1/35 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
0.00%
0/35 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
General disorders
Unexpected abdominal pain and diarrhea
0.00%
0/35 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
2.9%
1/35 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
General disorders
Unexpected nose bleed
0.00%
0/35 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
2.9%
1/35 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
Ear and labyrinth disorders
Unexpected ear fullness
2.9%
1/35 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
0.00%
0/35 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
General disorders
Unexpected dizziness and abdominal pain
0.00%
0/35 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
2.9%
1/35 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
General disorders
Unexpected fall
8.6%
3/35 • Number of events 5 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
0.00%
0/35 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
General disorders
Unexpected leg cramps
5.7%
2/35 • Number of events 2 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
0.00%
0/35 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
General disorders
Unexpected kidney stone
2.9%
1/35 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
0.00%
0/35 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
General disorders
Unexpected flank pain
2.9%
1/35 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
0.00%
0/35 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
Gastrointestinal disorders
Unexpected gastrointestinal problems
0.00%
0/35 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
2.9%
1/35 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
General disorders
Unexpected shortness of breath
2.9%
1/35 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
0.00%
0/35 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
General disorders
Unexpected ankle injury
2.9%
1/35 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
0.00%
0/35 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
General disorders
Unexpected episode of high blood pressure
2.9%
1/35 • Number of events 1 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
0.00%
0/35 • 24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."

Additional Information

Dr. Jeff Huffman

Massachusetts General Hospital

Phone: 617-724-2910

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place