Trial Outcomes & Findings for Testing Adaptive Interventions to Improve Physical Activity for Sedentary Women (NCT NCT03558828)

NCT ID: NCT03558828

Last Updated: 2025-08-03

Results Overview

Physical activity-Steps: Average daily steps were measured with ActiGraph worn on the right hip during waking hours for one week.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

301 participants

Primary outcome timeframe

Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for steps.

Results posted on

2025-08-03

Participant Flow

Response to reviewer's comment #2- Each arm includes a specific title and time period. For Column #7 during the maintenance period, a total of 301 participants were analyzed. If we were to include "301" again in this column, the total would add up to 602, which would count the same participants twice. To avoid the double-counting and to keep the total participant number as 301, I've added column #7 but entered n as 0 in the maintenance period column. Comment #3. Response: footnote removed

Excluded: 453 * Unable to be reached: 163 * Not Interested: 193 * Ineligible: 97 * failed phone screening: 14 * failed health screening: 33 * failed physical activity screening: 50

Participant milestones

Participant milestones
Measure
Enhanced Physical Activity Monitor Only
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor only" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps. Step 2: Responder Treatment (weeks 9-34)- responders to "Enhanced Physical Activity Monitor only" treatment continued with this assigned treatment. Step 3: Maintenance (weeks 35-50)- responders to "Enhanced Physical Activity Monitor only" treatment continued with this assigned treatment.
Enhanced Physical Activity Monitor+ Motivational Text Messages
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps + Text Messages. Step 2: Responder Treatment (weeks 9-34)- responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with this assigned treatment. Step 3: Maintenance (weeks 35-50)- responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with "Enhanced Physical Activity Monitor" only .
Enhanced Physical Activity Monitor Only+ Personal Calls
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor only" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor only" treatment continued with Enhanced Physical Activity Monitor plus were randomized to receive Personal Calls. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor only" treatment continued with "Enhanced Physical Activity Monitor" only.
Enhanced Physical Activity Monitor Only+ Group Meetings
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor only" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor only" treatment continued with Enhanced Physical Activity Monitor plus were randomized to participate in Group Meetings. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor only" treatment continued with "Enhanced Physical Activity Monitor" only.
Enhanced Physical Activity Monitor+ Motivational Text Messages+ Personal Calls
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps + Text Messages. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with this assigned treatment plus were randomized to receive Personal Calls. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with "Enhanced Physical Activity Monitor" only .
Enhanced Physical Activity Monitor+ Motivational Text Messages+ Group Meetings
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps + Text Messages. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with this assigned treatment plus were randomized to participate in Group Meetings. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with "Enhanced Physical Activity Monitor" only .
Overall Study
STARTED
76
81
38
35
35
36
Overall Study
COMPLETED
71
77
35
30
33
33
Overall Study
NOT COMPLETED
5
4
3
5
2
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Enhanced Physical Activity Monitor Only
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor only" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps. Step 2: Responder Treatment (weeks 9-34)- responders to "Enhanced Physical Activity Monitor only" treatment continued with this assigned treatment. Step 3: Maintenance (weeks 35-50)- responders to "Enhanced Physical Activity Monitor only" treatment continued with this assigned treatment.
Enhanced Physical Activity Monitor+ Motivational Text Messages
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps + Text Messages. Step 2: Responder Treatment (weeks 9-34)- responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with this assigned treatment. Step 3: Maintenance (weeks 35-50)- responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with "Enhanced Physical Activity Monitor" only .
Enhanced Physical Activity Monitor Only+ Personal Calls
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor only" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor only" treatment continued with Enhanced Physical Activity Monitor plus were randomized to receive Personal Calls. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor only" treatment continued with "Enhanced Physical Activity Monitor" only.
Enhanced Physical Activity Monitor Only+ Group Meetings
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor only" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor only" treatment continued with Enhanced Physical Activity Monitor plus were randomized to participate in Group Meetings. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor only" treatment continued with "Enhanced Physical Activity Monitor" only.
Enhanced Physical Activity Monitor+ Motivational Text Messages+ Personal Calls
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps + Text Messages. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with this assigned treatment plus were randomized to receive Personal Calls. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with "Enhanced Physical Activity Monitor" only .
Enhanced Physical Activity Monitor+ Motivational Text Messages+ Group Meetings
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps + Text Messages. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with this assigned treatment plus were randomized to participate in Group Meetings. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with "Enhanced Physical Activity Monitor" only .
Overall Study
Lost to Follow-up
4
3
3
5
2
3
Overall Study
dropped before the intervention
1
1
0
0
0
0

Baseline Characteristics

Testing Adaptive Interventions to Improve Physical Activity for Sedentary Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Step1: Initial Treatment (Weeks 1-8) Enhanced Physical Activity Monitor Only
n=149 Participants
Step1: Initial Treatment (weeks 1-8) enhanced physical activity monitor only: In this group, participants were randomly assigned to an enhanced physical activity monitor only, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps. For baseline characteristics, this step includes both responders and non-responders from the physical activity monitor-only treatment group.
Step1: Initial Treatment (Weeks 1-8) Enhanced Physical Activity Monitor + Text Messages
n=152 Participants
Step1: Initial Treatment (weeks 1-8) enhanced physical activity monitor +motivational text messaging: In this group, participants were randomly assigned to an enhanced physical activity monitor (Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps) + text messages. For baseline characteristics, this step includes both responders and non-responders from the physical activity monitor + text messages treatment group.
Total
n=301 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
Age, Categorical
Between 18 and 65 years
149 Participants
n=39 Participants
152 Participants
n=41 Participants
301 Participants
n=35 Participants
Age, Categorical
>=65 years
0 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
Age, Continuous
45.1 years
STANDARD_DEVIATION 11.6 • n=39 Participants
46.1 years
STANDARD_DEVIATION 11.2 • n=41 Participants
45.6 years
STANDARD_DEVIATION 11.4 • n=35 Participants
Sex: Female, Male
Female
149 Participants
n=39 Participants
152 Participants
n=41 Participants
301 Participants
n=35 Participants
Sex: Female, Male
Male
0 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
Race (NIH/OMB)
Asian
7 Participants
n=39 Participants
16 Participants
n=41 Participants
23 Participants
n=35 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
Race (NIH/OMB)
Black or African American
44 Participants
n=39 Participants
48 Participants
n=41 Participants
92 Participants
n=35 Participants
Race (NIH/OMB)
White
78 Participants
n=39 Participants
74 Participants
n=41 Participants
152 Participants
n=35 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
Race (NIH/OMB)
Unknown or Not Reported
20 Participants
n=39 Participants
14 Participants
n=41 Participants
34 Participants
n=35 Participants
Region of Enrollment
United States
149 participants
n=39 Participants
152 participants
n=41 Participants
301 participants
n=35 Participants
Average daily steps
4913.95 Number of steps (M, 95% CI)
n=39 Participants
5082.05 Number of steps (M, 95% CI)
n=41 Participants
4998 Number of steps (M, 95% CI)
n=35 Participants
Average daily minutes of moderate/vigorous PA (MVPA)
13.5 Number pf MVPA minutes/day (M, 95% CI)
n=39 Participants
13.7 Number pf MVPA minutes/day (M, 95% CI)
n=41 Participants
13.6 Number pf MVPA minutes/day (M, 95% CI)
n=35 Participants

PRIMARY outcome

Timeframe: Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for steps.

Population: Total N=301 participants were analyzed.

Physical activity-Steps: Average daily steps were measured with ActiGraph worn on the right hip during waking hours for one week.

Outcome measures

Outcome measures
Measure
Enhanced Physical Activity Monitor Only
n=76 Participants
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor only" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps. Step 2: Responder Treatment (weeks 9-34)- responders to "Enhanced Physical Activity Monitor only" treatment continued with this assigned treatment. Step 3: Maintenance (weeks 35-50)- responders to "Enhanced Physical Activity Monitor only" treatment continued with this assigned treatment.
Enhanced Physical Activity Monitor+ Motivational Text Messages
n=81 Participants
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps + Text Messages. Step 2: Responder Treatment (weeks 9-34)- responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with this assigned treatment. Step 3: Maintenance (weeks 35-50)- responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with "Enhanced Physical Activity Monitor" only.
Enhanced Physical Activity Monitor Only+ Personal Calls
n=38 Participants
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor only" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor only" treatment continued with Enhanced Physical Activity Monitor plus were randomized to receive Personal Calls. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor only" treatment continued with "Enhanced Physical Activity Monitor" only.
Enhanced Physical Activity Monitor Only+ Group Meetings
n=35 Participants
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor only" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor only" treatment continued with Enhanced Physical Activity Monitor plus were randomized to participate in Group Meetings. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor only" treatment continued with "Enhanced Physical Activity Monitor" only.
Enhanced Physical Activity Monitor+ Motivational Text Messages+ Personal Calls
n=35 Participants
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps + Text Messages. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with this assigned treatment plus were randomized to receive Personal Calls. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with "Enhanced Physical Activity Monitor" only.
Enhanced Physical Activity Monitor+ Motivational Text Messages+ Group Meetings
n=36 Participants
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps + Text Messages. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with this assigned treatment plus were randomized to participate in Group Meetings. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with "Enhanced Physical Activity Monitor" only .
Physical Activity-Steps
5637.2 Number of steps/day
Interval 5215.0 to 6045.0
5863.3 Number of steps/day
Interval 5443.0 to 6275.0
5603.9 Number of steps/day
Interval 5164.0 to 6044.0
5631.6 Number of steps/day
Interval 5194.0 to 6070.0
5636.7 Number of steps/day
Interval 5214.0 to 6060.0
5322.0 Number of steps/day
Interval 4892.0 to 5752.0

PRIMARY outcome

Timeframe: Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for MVPA.

Population: Total N=301 participants were analyzed.

Average daily minutes of Moderate to Vigorous Physical Activity (MVPA) were measured with ActiGraph worn on the right hip during waking hours for one week.

Outcome measures

Outcome measures
Measure
Enhanced Physical Activity Monitor Only
n=76 Participants
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor only" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps. Step 2: Responder Treatment (weeks 9-34)- responders to "Enhanced Physical Activity Monitor only" treatment continued with this assigned treatment. Step 3: Maintenance (weeks 35-50)- responders to "Enhanced Physical Activity Monitor only" treatment continued with this assigned treatment.
Enhanced Physical Activity Monitor+ Motivational Text Messages
n=81 Participants
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps + Text Messages. Step 2: Responder Treatment (weeks 9-34)- responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with this assigned treatment. Step 3: Maintenance (weeks 35-50)- responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with "Enhanced Physical Activity Monitor" only.
Enhanced Physical Activity Monitor Only+ Personal Calls
n=38 Participants
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor only" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor only" treatment continued with Enhanced Physical Activity Monitor plus were randomized to receive Personal Calls. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor only" treatment continued with "Enhanced Physical Activity Monitor" only.
Enhanced Physical Activity Monitor Only+ Group Meetings
n=35 Participants
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor only" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor only" treatment continued with Enhanced Physical Activity Monitor plus were randomized to participate in Group Meetings. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor only" treatment continued with "Enhanced Physical Activity Monitor" only.
Enhanced Physical Activity Monitor+ Motivational Text Messages+ Personal Calls
n=35 Participants
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps + Text Messages. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with this assigned treatment plus were randomized to receive Personal Calls. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with "Enhanced Physical Activity Monitor" only.
Enhanced Physical Activity Monitor+ Motivational Text Messages+ Group Meetings
n=36 Participants
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps + Text Messages. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with this assigned treatment plus were randomized to participate in Group Meetings. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with "Enhanced Physical Activity Monitor" only .
Physical Activity- Moderate to Vigorous Physical Activity (MVPA)
17.4 Number of MVPA minutes/day
Interval 14.9 to 19.7
18.0 Number of MVPA minutes/day
Interval 15.2 to 21.1
18.8 Number of MVPA minutes/day
Interval 15.5 to 22.2
17.9 Number of MVPA minutes/day
Interval 14.8 to 21.0
18.6 Number of MVPA minutes/day
Interval 15.7 to 21.5
17.7 Number of MVPA minutes/day
Interval 14.1 to 21.3

SECONDARY outcome

Timeframe: Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for aerobic fitness.

Population: Total N=301 participants were analyzed.

Aerobic fitness: participants step in place to a predesignated height for 2 minutes and the average number of steps taken in 2 minutes are counted.

Outcome measures

Outcome measures
Measure
Enhanced Physical Activity Monitor Only
n=76 Participants
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor only" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps. Step 2: Responder Treatment (weeks 9-34)- responders to "Enhanced Physical Activity Monitor only" treatment continued with this assigned treatment. Step 3: Maintenance (weeks 35-50)- responders to "Enhanced Physical Activity Monitor only" treatment continued with this assigned treatment.
Enhanced Physical Activity Monitor+ Motivational Text Messages
n=81 Participants
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps + Text Messages. Step 2: Responder Treatment (weeks 9-34)- responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with this assigned treatment. Step 3: Maintenance (weeks 35-50)- responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with "Enhanced Physical Activity Monitor" only.
Enhanced Physical Activity Monitor Only+ Personal Calls
n=38 Participants
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor only" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor only" treatment continued with Enhanced Physical Activity Monitor plus were randomized to receive Personal Calls. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor only" treatment continued with "Enhanced Physical Activity Monitor" only.
Enhanced Physical Activity Monitor Only+ Group Meetings
n=35 Participants
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor only" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor only" treatment continued with Enhanced Physical Activity Monitor plus were randomized to participate in Group Meetings. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor only" treatment continued with "Enhanced Physical Activity Monitor" only.
Enhanced Physical Activity Monitor+ Motivational Text Messages+ Personal Calls
n=35 Participants
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps + Text Messages. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with this assigned treatment plus were randomized to receive Personal Calls. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with "Enhanced Physical Activity Monitor" only.
Enhanced Physical Activity Monitor+ Motivational Text Messages+ Group Meetings
n=36 Participants
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps + Text Messages. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with this assigned treatment plus were randomized to participate in Group Meetings. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with "Enhanced Physical Activity Monitor" only .
Cardiovascular Health (1)
85.7 Number of steps/2 minutes
Interval 81.5 to 90.1
87.1 Number of steps/2 minutes
Interval 82.2 to 92.2
86.3 Number of steps/2 minutes
Interval 81.2 to 91.4
89.9 Number of steps/2 minutes
Interval 85.2 to 94.7
86 Number of steps/2 minutes
Interval 81.4 to 90.6
88.7 Number of steps/2 minutes
Interval 83.9 to 93.5

SECONDARY outcome

Timeframe: Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for BMI.

Population: Total N=301 participants were analyzed.

Body composition: Average BMI (weight measured in pounds; height measured in inches) was measured utilizing BMI calculation formula: BMI = Weight (kg) / Height (m)²

Outcome measures

Outcome measures
Measure
Enhanced Physical Activity Monitor Only
n=76 Participants
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor only" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps. Step 2: Responder Treatment (weeks 9-34)- responders to "Enhanced Physical Activity Monitor only" treatment continued with this assigned treatment. Step 3: Maintenance (weeks 35-50)- responders to "Enhanced Physical Activity Monitor only" treatment continued with this assigned treatment.
Enhanced Physical Activity Monitor+ Motivational Text Messages
n=81 Participants
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps + Text Messages. Step 2: Responder Treatment (weeks 9-34)- responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with this assigned treatment. Step 3: Maintenance (weeks 35-50)- responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with "Enhanced Physical Activity Monitor" only.
Enhanced Physical Activity Monitor Only+ Personal Calls
n=38 Participants
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor only" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor only" treatment continued with Enhanced Physical Activity Monitor plus were randomized to receive Personal Calls. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor only" treatment continued with "Enhanced Physical Activity Monitor" only.
Enhanced Physical Activity Monitor Only+ Group Meetings
n=35 Participants
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor only" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor only" treatment continued with Enhanced Physical Activity Monitor plus were randomized to participate in Group Meetings. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor only" treatment continued with "Enhanced Physical Activity Monitor" only.
Enhanced Physical Activity Monitor+ Motivational Text Messages+ Personal Calls
n=35 Participants
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps + Text Messages. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with this assigned treatment plus were randomized to receive Personal Calls. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with "Enhanced Physical Activity Monitor" only.
Enhanced Physical Activity Monitor+ Motivational Text Messages+ Group Meetings
n=36 Participants
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps + Text Messages. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with this assigned treatment plus were randomized to participate in Group Meetings. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with "Enhanced Physical Activity Monitor" only .
Cardiovascular Health (2)
31.8 weight (pounds)/height (Inches)^2x703
Interval 30.4 to 33.2
32.4 weight (pounds)/height (Inches)^2x703
Interval 30.8 to 34.2
31.3 weight (pounds)/height (Inches)^2x703
Interval 29.8 to 32.8
31.6 weight (pounds)/height (Inches)^2x703
Interval 30.1 to 33.1
32.2 weight (pounds)/height (Inches)^2x703
Interval 30.6 to 33.9
32.1 weight (pounds)/height (Inches)^2x703
Interval 30.5 to 33.8

SECONDARY outcome

Timeframe: Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for waist measurement.

Population: Total N=301 participants were analyzed.

Body composition: Average waist circumference was measured in inches.

Outcome measures

Outcome measures
Measure
Enhanced Physical Activity Monitor Only
n=76 Participants
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor only" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps. Step 2: Responder Treatment (weeks 9-34)- responders to "Enhanced Physical Activity Monitor only" treatment continued with this assigned treatment. Step 3: Maintenance (weeks 35-50)- responders to "Enhanced Physical Activity Monitor only" treatment continued with this assigned treatment.
Enhanced Physical Activity Monitor+ Motivational Text Messages
n=81 Participants
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps + Text Messages. Step 2: Responder Treatment (weeks 9-34)- responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with this assigned treatment. Step 3: Maintenance (weeks 35-50)- responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with "Enhanced Physical Activity Monitor" only.
Enhanced Physical Activity Monitor Only+ Personal Calls
n=38 Participants
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor only" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor only" treatment continued with Enhanced Physical Activity Monitor plus were randomized to receive Personal Calls. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor only" treatment continued with "Enhanced Physical Activity Monitor" only.
Enhanced Physical Activity Monitor Only+ Group Meetings
n=35 Participants
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor only" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor only" treatment continued with Enhanced Physical Activity Monitor plus were randomized to participate in Group Meetings. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor only" treatment continued with "Enhanced Physical Activity Monitor" only.
Enhanced Physical Activity Monitor+ Motivational Text Messages+ Personal Calls
n=35 Participants
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps + Text Messages. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with this assigned treatment plus were randomized to receive Personal Calls. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with "Enhanced Physical Activity Monitor" only.
Enhanced Physical Activity Monitor+ Motivational Text Messages+ Group Meetings
n=36 Participants
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps + Text Messages. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with this assigned treatment plus were randomized to participate in Group Meetings. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with "Enhanced Physical Activity Monitor" only .
Cardiovascular Health (3)
38.1 Inches
Interval 36.9 to 39.4
38.7 Inches
Interval 36.9 to 40.0
38.4 Inches
Interval 37.1 to 39.7
39 Inches
Interval 37.8 to 40.2
39.8 Inches
Interval 38.4 to 41.2
38.7 Inches
Interval 37.4 to 40.0

Adverse Events

Enhanced Physical Activity Monitor Only

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Enhanced Physical Activity Monitor+ Motivational Text Messages

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

Enhanced Physical Activity Monitor Only+ Personal Calls

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

Enhanced Physical Activity Monitor Only+ Group Meetings

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

Enhanced Physical Activity Monitor+ Motivational Text Messages+ Personal Calls

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

Enhanced Physical Activity Monitor+ Motivational Text Messages+ Group Meetings

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

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Enhanced Physical Activity Monitor Only
n=76 participants at risk
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor only" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps. Step 2: Responder Treatment (weeks 9-34)- responders to "Enhanced Physical Activity Monitor only" treatment continued with this assigned treatment. Step 3: Maintenance (weeks 35-50)- responders to "Enhanced Physical Activity Monitor only" treatment continued with this assigned treatment.
Enhanced Physical Activity Monitor+ Motivational Text Messages
n=81 participants at risk
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps + Text Messages. Step 2: Responder Treatment (weeks 9-34)- responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with this assigned treatment. Step 3: Maintenance (weeks 35-50)- responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with "Enhanced Physical Activity Monitor" only.
Enhanced Physical Activity Monitor Only+ Personal Calls
n=38 participants at risk
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor only" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor only" treatment continued with Enhanced Physical Activity Monitor plus were randomized to receive Personal Calls. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor only" treatment continued with "Enhanced Physical Activity Monitor" only.
Enhanced Physical Activity Monitor Only+ Group Meetings
n=35 participants at risk
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps + Text Messages. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with this assigned treatment plus were randomized to receive Personal Calls. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with "Enhanced Physical Activity Monitor" only.
Enhanced Physical Activity Monitor+ Motivational Text Messages+ Personal Calls
n=35 participants at risk
Step1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps + Text Messages. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with this assigned treatment plus were randomized to receive Personal Calls. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with "Enhanced Physical Activity Monitor" only.
Enhanced Physical Activity Monitor+ Motivational Text Messages+ Group Meetings
n=36 participants at risk
Step 1: Initial Treatment (weeks 1-8)- participants were randomly assigned to an "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps + Text Messages. Step 2: Non-responder Treatment (weeks 9-34)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with this assigned treatment plus were randomized to participate in Group Meetings. Step 3: Maintenance (weeks 35-50)- non-responders to "Enhanced Physical Activity Monitor + Motivational Text Messages" treatment continued with "Enhanced Physical Activity Monitor" only.
Cardiac disorders
Elevated blood pressure
3.9%
3/76 • Number of events 3 • Monitored during Step 1: initial treatment period (weeks 1-8), Step 2: augmented treatment period (weeks 9-34), and Step 3: Maintenance period (weeks 35-50)
Included all participants (N=301) in initial treatment period (weeks 1-8), augmented treatment period (weeks 9-34), and Maintenance period (weeks 35-50).
0.00%
0/81 • Monitored during Step 1: initial treatment period (weeks 1-8), Step 2: augmented treatment period (weeks 9-34), and Step 3: Maintenance period (weeks 35-50)
Included all participants (N=301) in initial treatment period (weeks 1-8), augmented treatment period (weeks 9-34), and Maintenance period (weeks 35-50).
0.00%
0/38 • Monitored during Step 1: initial treatment period (weeks 1-8), Step 2: augmented treatment period (weeks 9-34), and Step 3: Maintenance period (weeks 35-50)
Included all participants (N=301) in initial treatment period (weeks 1-8), augmented treatment period (weeks 9-34), and Maintenance period (weeks 35-50).
0.00%
0/35 • Monitored during Step 1: initial treatment period (weeks 1-8), Step 2: augmented treatment period (weeks 9-34), and Step 3: Maintenance period (weeks 35-50)
Included all participants (N=301) in initial treatment period (weeks 1-8), augmented treatment period (weeks 9-34), and Maintenance period (weeks 35-50).
0.00%
0/35 • Monitored during Step 1: initial treatment period (weeks 1-8), Step 2: augmented treatment period (weeks 9-34), and Step 3: Maintenance period (weeks 35-50)
Included all participants (N=301) in initial treatment period (weeks 1-8), augmented treatment period (weeks 9-34), and Maintenance period (weeks 35-50).
0.00%
0/36 • Monitored during Step 1: initial treatment period (weeks 1-8), Step 2: augmented treatment period (weeks 9-34), and Step 3: Maintenance period (weeks 35-50)
Included all participants (N=301) in initial treatment period (weeks 1-8), augmented treatment period (weeks 9-34), and Maintenance period (weeks 35-50).

Additional Information

Manju Daniel

Rush University College of Nursing

Phone: 312.942.3460

Results disclosure agreements

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