Trial Outcomes & Findings for Financial Incentives to Exercise for Adolescents (NCT NCT01848353)
NCT ID: NCT01848353
Last Updated: 2019-04-03
Results Overview
Frequency and duration of moderate-to-vigorous physical activity will be measured using heart rate monitors. The monitors will be worn each exercise session. Participants are asked to complete 3 exercise sessions per week throughout the 48-week period of enrollment. The primary comparison between the experimental and active comparator groups will be the volume of exercise (total time) accumulated. Comparisons will be made for accumulated exercise volume at 16, 32, and 48 weeks and the change from baseline (week 0).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
142 participants
Primary outcome timeframe
at baseline (week 0) and weeks 16, 32, and 48.
Results posted on
2019-04-03
Participant Flow
Recruitment for the exercise intervention was July 2013 - April 2016. Recruitment for the reference group was July 2015 - April 2017. All participants were were recruited from medical clinics, schools, or community settings in Southeast Oklahoma.
142 people enrolled (completed informed consent). During screening, 4 OW/Ob and 8 NW people were disqualified, and 5 OW/Ob and 5 NW people voluntarily withdrew. Baseline data were thus available for 120 people. After baseline testing was complete, 81 OW/Ob participants were randomly assigned to either standard pay or incentive group for Phase 1.
Participant milestones
| Measure |
Standard Payment
All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes. All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Incentivized Payment
All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they increase exercise frequency (number of days) during weeks 1-16 (phase 1), or increase exercise duration (minutes per session) during weeks 17-32 (phase 2). In phase 3 the payment will be a lottery, with the number of lottery chances based on exercise frequency and duration. All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Normal Weight, Low Activity Group
This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have low physical activity and fitness like the intervention group. Therefore differences in their results with the intervention group will reflect the effects of overweight/obesity on the variables of interest.
|
Normal Weight, High Activity Group
This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have higher physical activity and fitness than the intervention group. They will therefore serve as a healthy reference group and differences in their results with the intervention group will reflect the effects of both overweight/obesity and physical activity on the variables of interest.
|
|---|---|---|---|---|
|
Phase 1
STARTED
|
38
|
43
|
20
|
19
|
|
Phase 1
COMPLETED
|
35
|
42
|
20
|
19
|
|
Phase 1
NOT COMPLETED
|
3
|
1
|
0
|
0
|
|
Phase 2
STARTED
|
23
|
28
|
0
|
0
|
|
Phase 2
COMPLETED
|
20
|
26
|
0
|
0
|
|
Phase 2
NOT COMPLETED
|
3
|
2
|
0
|
0
|
|
Phase 3
STARTED
|
5
|
10
|
0
|
0
|
|
Phase 3
COMPLETED
|
4
|
9
|
0
|
0
|
|
Phase 3
NOT COMPLETED
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Standard Payment
All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes. All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Incentivized Payment
All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they increase exercise frequency (number of days) during weeks 1-16 (phase 1), or increase exercise duration (minutes per session) during weeks 17-32 (phase 2). In phase 3 the payment will be a lottery, with the number of lottery chances based on exercise frequency and duration. All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Normal Weight, Low Activity Group
This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have low physical activity and fitness like the intervention group. Therefore differences in their results with the intervention group will reflect the effects of overweight/obesity on the variables of interest.
|
Normal Weight, High Activity Group
This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have higher physical activity and fitness than the intervention group. They will therefore serve as a healthy reference group and differences in their results with the intervention group will reflect the effects of both overweight/obesity and physical activity on the variables of interest.
|
|---|---|---|---|---|
|
Phase 1
Withdrawal by Subject
|
3
|
1
|
0
|
0
|
|
Phase 2
Withdrawal by Subject
|
3
|
2
|
0
|
0
|
|
Phase 3
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Financial Incentives to Exercise for Adolescents
Baseline characteristics by cohort
| Measure |
Standard Payment, Phase 1
n=38 Participants
All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Incentivized Payment, Phase 1
n=43 Participants
All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they increase exercise frequency (number of days) during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Normal Weight, Low Activity Group
n=20 Participants
This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have low physical activity and fitness like the intervention group. Therefore differences in their results with the intervention group will reflect the effects of overweight/obesity on the variables of interest.
|
Normal Weight, High Activity Group
n=19 Participants
This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have higher physical activity and fitness than the intervention group. They will therefore serve as a healthy reference group and differences in their results with the intervention group will reflect the effects of both overweight/obesity and physical activity on the variables of interest.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
13.8 years
STANDARD_DEVIATION 2.2 • n=93 Participants
|
14.2 years
STANDARD_DEVIATION 2.2 • n=4 Participants
|
14.6 years
STANDARD_DEVIATION 2.3 • n=27 Participants
|
14.3 years
STANDARD_DEVIATION 1.9 • n=483 Participants
|
14.4 years
STANDARD_DEVIATION 2.3 • n=36 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
64 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
56 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
38 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
120 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=93 Participants
|
43 participants
n=4 Participants
|
20 participants
n=27 Participants
|
19 participants
n=483 Participants
|
186 participants
n=36 Participants
|
|
Body mass index
|
33.4 kg/m^2
STANDARD_DEVIATION 7.0 • n=93 Participants
|
34.8 kg/m^2
STANDARD_DEVIATION 6.1 • n=4 Participants
|
20.8 kg/m^2
STANDARD_DEVIATION 1.9 • n=27 Participants
|
20.1 kg/m^2
STANDARD_DEVIATION 2.4 • n=483 Participants
|
30.1 kg/m^2
STANDARD_DEVIATION 9.0 • n=36 Participants
|
PRIMARY outcome
Timeframe: at baseline (week 0) and weeks 16, 32, and 48.Population: In Phase 1, 81 people were randomized, but 4 withdrew after assignment so 77 people had exercise behavior data for analyses. In Phase 2, 51 were randomized, but 5 withdrew after assignment, leaving 46 for behavior analyses. In Phase 3, 15 were randomized, 2 withdrew after assignment, leaving 13 for behavior analyses.
Frequency and duration of moderate-to-vigorous physical activity will be measured using heart rate monitors. The monitors will be worn each exercise session. Participants are asked to complete 3 exercise sessions per week throughout the 48-week period of enrollment. The primary comparison between the experimental and active comparator groups will be the volume of exercise (total time) accumulated. Comparisons will be made for accumulated exercise volume at 16, 32, and 48 weeks and the change from baseline (week 0).
Outcome measures
| Measure |
Standard Payment, Phase 1
n=35 Participants
All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Incentivized Payment, Phase 1
n=42 Participants
All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they increase exercise frequency (number of days) during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Standard Payment, Phase 2
n=20 Participants
All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Incentivized Payment, Phase 2
n=26 Participants
All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they exercise for longer than 20 minutes per session during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Ramp-down Payment, Phase 3
n=4 Participants
All participants will perform exercise training. This phase will last from weeks 33-48 (phase 3). Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes, but the value of the payments will decrease weekly (ramp-down) until reaching zero in week 41. All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Raffle Payment, Phase 3
n=9 Participants
All participants will perform exercise training. In weeks 33-48 (phase 3)participants in this arm will receive fewer financial incentives than in the prior 32 weeks but they will be delivered through a raffle system to utilize a variable reinforcement approach. All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Normal Weight, Low Activity Group
This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have low physical activity and fitness like the intervention group. Therefore differences in their results with the intervention group will reflect the effects of overweight/obesity on the variables of interest.
|
Normal Weight, High Activity Group
This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have higher physical activity and fitness than the intervention group. They will therefore serve as a healthy reference group and differences in their results with the intervention group will reflect the effects of both overweight/obesity and physical activity on the variables of interest.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Volume of Exercise (Total Time)
|
15.2 hours
Standard Deviation 10.1
|
15.0 hours
Standard Deviation 8.1
|
8.0 hours
Standard Deviation 5.5
|
12.4 hours
Standard Deviation 11.1
|
10.2 hours
Standard Deviation 3.8
|
8.8 hours
Standard Deviation 4.7
|
—
|
—
|
SECONDARY outcome
Timeframe: at baseline (week 0) and weeks 16, 32, and 48.Population: In Phase 1, 20 out of 77 people who started were lost to follow-up so post-test data were not available. In Phase 2, 26 out of 46 people who started were lost to follow-up. In Phase 3, 3 out of 13 people who started were lost to follow-up.
Fasting blood glucose and insulin concentration will be measured and used to calculate the homeostatic model of assessment for insulin resistance (iHOMA2, %S). Testing will be performed at baseline (week 0) and weeks 16, 32, and 48. Data analysis will focus on the change from baseline and whether that change differs between groups.
Outcome measures
| Measure |
Standard Payment, Phase 1
n=25 Participants
All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Incentivized Payment, Phase 1
n=32 Participants
All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they increase exercise frequency (number of days) during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Standard Payment, Phase 2
n=9 Participants
All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Incentivized Payment, Phase 2
n=11 Participants
All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they exercise for longer than 20 minutes per session during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Ramp-down Payment, Phase 3
n=4 Participants
All participants will perform exercise training. This phase will last from weeks 33-48 (phase 3). Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes, but the value of the payments will decrease weekly (ramp-down) until reaching zero in week 41. All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Raffle Payment, Phase 3
n=6 Participants
All participants will perform exercise training. In weeks 33-48 (phase 3)participants in this arm will receive fewer financial incentives than in the prior 32 weeks but they will be delivered through a raffle system to utilize a variable reinforcement approach. All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Normal Weight, Low Activity Group
n=20 Participants
This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have low physical activity and fitness like the intervention group. Therefore differences in their results with the intervention group will reflect the effects of overweight/obesity on the variables of interest.
|
Normal Weight, High Activity Group
n=19 Participants
This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have higher physical activity and fitness than the intervention group. They will therefore serve as a healthy reference group and differences in their results with the intervention group will reflect the effects of both overweight/obesity and physical activity on the variables of interest.
|
|---|---|---|---|---|---|---|---|---|
|
Insulin Resistance
|
75 % of sensitivity
Standard Deviation 49
|
69 % of sensitivity
Standard Deviation 44
|
66 % of sensitivity
Standard Deviation 36
|
77 % of sensitivity
Standard Deviation 45
|
57 % of sensitivity
Standard Deviation 28
|
65 % of sensitivity
Standard Deviation 35
|
170 % of sensitivity
Standard Deviation 75
|
179 % of sensitivity
Standard Deviation 92
|
SECONDARY outcome
Timeframe: at baseline (week 0) and weeks 16, 32, and 48.Population: In Phase 1, 20 out of 77 people who started were lost to follow-up so post-test data were not available. In Phase 2, 26 out of 46 people who started were lost to follow-up. In Phase 3, 3 out of 13 people who started were lost to follow-up. Missing data: 2 people in Phase 1 (1 in each group), 1 person in NW low activity group.
Peak oxygen uptake (VO2max) during a progressive intensity bicycle test to fatigue. Testing will be performed at baseline (week 0) and weeks 16, 32, and 48. Data analysis will focus on the change from baseline and whether that change differs between groups.
Outcome measures
| Measure |
Standard Payment, Phase 1
n=24 Participants
All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Incentivized Payment, Phase 1
n=31 Participants
All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they increase exercise frequency (number of days) during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Standard Payment, Phase 2
n=9 Participants
All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Incentivized Payment, Phase 2
n=11 Participants
All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they exercise for longer than 20 minutes per session during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Ramp-down Payment, Phase 3
n=4 Participants
All participants will perform exercise training. This phase will last from weeks 33-48 (phase 3). Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes, but the value of the payments will decrease weekly (ramp-down) until reaching zero in week 41. All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Raffle Payment, Phase 3
n=6 Participants
All participants will perform exercise training. In weeks 33-48 (phase 3)participants in this arm will receive fewer financial incentives than in the prior 32 weeks but they will be delivered through a raffle system to utilize a variable reinforcement approach. All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Normal Weight, Low Activity Group
n=19 Participants
This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have low physical activity and fitness like the intervention group. Therefore differences in their results with the intervention group will reflect the effects of overweight/obesity on the variables of interest.
|
Normal Weight, High Activity Group
n=19 Participants
This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have higher physical activity and fitness than the intervention group. They will therefore serve as a healthy reference group and differences in their results with the intervention group will reflect the effects of both overweight/obesity and physical activity on the variables of interest.
|
|---|---|---|---|---|---|---|---|---|
|
Exercise Fitness
|
36.9 ml/kg fat free mass/minute
Standard Deviation 8.0
|
37.4 ml/kg fat free mass/minute
Standard Deviation 8.6
|
39.0 ml/kg fat free mass/minute
Standard Deviation 10.8
|
39.2 ml/kg fat free mass/minute
Standard Deviation 12.9
|
39.2 ml/kg fat free mass/minute
Standard Deviation 5.8
|
43.0 ml/kg fat free mass/minute
Standard Deviation 6.6
|
61.7 ml/kg fat free mass/minute
Standard Deviation 7.5
|
45.1 ml/kg fat free mass/minute
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: at baseline (week 0) and weeks 16, 32, and 48.Population: In Phase 1, 20 out of 77 people who started were lost to follow-up so post-test data were not available. In Phase 2, 26 out of 46 people who started were lost to follow-up. In Phase 3, 3 out of 13 people who started were lost to follow-up. Missing data: 1 person in NW Lo fit group.
Body fat content. Testing will be performed at baseline (week 0) and weeks 16, 32, and 48. Data analysis will focus on the change from baseline and whether that change differs between groups.
Outcome measures
| Measure |
Standard Payment, Phase 1
n=25 Participants
All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Incentivized Payment, Phase 1
n=32 Participants
All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they increase exercise frequency (number of days) during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Standard Payment, Phase 2
n=9 Participants
All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Incentivized Payment, Phase 2
n=11 Participants
All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they exercise for longer than 20 minutes per session during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Ramp-down Payment, Phase 3
n=4 Participants
All participants will perform exercise training. This phase will last from weeks 33-48 (phase 3). Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes, but the value of the payments will decrease weekly (ramp-down) until reaching zero in week 41. All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Raffle Payment, Phase 3
n=6 Participants
All participants will perform exercise training. In weeks 33-48 (phase 3)participants in this arm will receive fewer financial incentives than in the prior 32 weeks but they will be delivered through a raffle system to utilize a variable reinforcement approach. All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Normal Weight, Low Activity Group
n=19 Participants
This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have low physical activity and fitness like the intervention group. Therefore differences in their results with the intervention group will reflect the effects of overweight/obesity on the variables of interest.
|
Normal Weight, High Activity Group
n=19 Participants
This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have higher physical activity and fitness than the intervention group. They will therefore serve as a healthy reference group and differences in their results with the intervention group will reflect the effects of both overweight/obesity and physical activity on the variables of interest.
|
|---|---|---|---|---|---|---|---|---|
|
Body Composition
|
43.9 Total body fat percentage
Standard Deviation 7.8
|
44.4 Total body fat percentage
Standard Deviation 7.7
|
40.8 Total body fat percentage
Standard Deviation 4.4
|
40.9 Total body fat percentage
Standard Deviation 7.1
|
40.4 Total body fat percentage
Standard Deviation 3.5
|
44.9 Total body fat percentage
Standard Deviation 9.1
|
21.2 Total body fat percentage
Standard Deviation 6.3
|
23.3 Total body fat percentage
Standard Deviation 7.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at baseline (week 0) and weeks 16, 32, and 48.Population: In Phase 1, 20 of 77 starters lost to follow-up (no post-test data). In Phase 2, 26 of 46 starters lost to follow-up. In Phase 3, 3 of 13 starters lost to follow-up. Missing data: Phase 1 (4 std, 5 incentive), Phase 2 (2 std, 3 incentive), Phase 3 (1 std, 2 incentive), NW (1 Low, 1 High).
Daily step counts measured with accelerometers. Testing will be performed at baseline (week 0) and weeks 16, 32, and 48. Data analysis will focus on the change from baseline and whether that change differs between groups.
Outcome measures
| Measure |
Standard Payment, Phase 1
n=21 Participants
All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Incentivized Payment, Phase 1
n=27 Participants
All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they increase exercise frequency (number of days) during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Standard Payment, Phase 2
n=7 Participants
All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Incentivized Payment, Phase 2
n=8 Participants
All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they exercise for longer than 20 minutes per session during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Ramp-down Payment, Phase 3
n=3 Participants
All participants will perform exercise training. This phase will last from weeks 33-48 (phase 3). Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes, but the value of the payments will decrease weekly (ramp-down) until reaching zero in week 41. All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Raffle Payment, Phase 3
n=4 Participants
All participants will perform exercise training. In weeks 33-48 (phase 3)participants in this arm will receive fewer financial incentives than in the prior 32 weeks but they will be delivered through a raffle system to utilize a variable reinforcement approach. All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Normal Weight, Low Activity Group
n=19 Participants
This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have low physical activity and fitness like the intervention group. Therefore differences in their results with the intervention group will reflect the effects of overweight/obesity on the variables of interest.
|
Normal Weight, High Activity Group
n=18 Participants
This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have higher physical activity and fitness than the intervention group. They will therefore serve as a healthy reference group and differences in their results with the intervention group will reflect the effects of both overweight/obesity and physical activity on the variables of interest.
|
|---|---|---|---|---|---|---|---|---|
|
Physical Activity
|
6048 steps per day
Standard Deviation 2711
|
6028 steps per day
Standard Deviation 3136
|
4862 steps per day
Standard Deviation 1217
|
6787 steps per day
Standard Deviation 4273
|
4166 steps per day
Standard Deviation 1882
|
6863 steps per day
Standard Deviation 2321
|
9492 steps per day
Standard Deviation 3176
|
8338 steps per day
Standard Deviation 3103
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at baseline (week 0) and weeks 16, 32, and 48.Population: In Phase 1, 20 out of 77 people who started were lost to follow-up so post-test data were not available. In Phase 2, 26 out of 46 people who started were lost to follow-up. In Phase 3, 3 out of 13 people who started were lost to follow-up.
Standard assessment of fasting triglycerides. Testing will be performed at baseline (week 0) and weeks 16, 32, and 48. Data analysis will focus on the change from baseline and whether that change differs between groups.
Outcome measures
| Measure |
Standard Payment, Phase 1
n=25 Participants
All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Incentivized Payment, Phase 1
n=32 Participants
All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they increase exercise frequency (number of days) during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Standard Payment, Phase 2
n=9 Participants
All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Incentivized Payment, Phase 2
n=11 Participants
All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they exercise for longer than 20 minutes per session during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Ramp-down Payment, Phase 3
n=4 Participants
All participants will perform exercise training. This phase will last from weeks 33-48 (phase 3). Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes, but the value of the payments will decrease weekly (ramp-down) until reaching zero in week 41. All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Raffle Payment, Phase 3
n=6 Participants
All participants will perform exercise training. In weeks 33-48 (phase 3)participants in this arm will receive fewer financial incentives than in the prior 32 weeks but they will be delivered through a raffle system to utilize a variable reinforcement approach. All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
|
Normal Weight, Low Activity Group
n=20 Participants
This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have low physical activity and fitness like the intervention group. Therefore differences in their results with the intervention group will reflect the effects of overweight/obesity on the variables of interest.
|
Normal Weight, High Activity Group
n=19 Participants
This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have higher physical activity and fitness than the intervention group. They will therefore serve as a healthy reference group and differences in their results with the intervention group will reflect the effects of both overweight/obesity and physical activity on the variables of interest.
|
|---|---|---|---|---|---|---|---|---|
|
Blood Lipids
|
92 mg/dl
Standard Deviation 56
|
97 mg/dl
Standard Deviation 68
|
64 mg/dl
Standard Deviation 30
|
114 mg/dl
Standard Deviation 87
|
83 mg/dl
Standard Deviation 50
|
102 mg/dl
Standard Deviation 80
|
51 mg/dl
Standard Deviation 24
|
60 mg/dl
Standard Deviation 30
|
Adverse Events
Standard Payment, Phase 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Incentivized Payment, Phase 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Payment, Phase 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Incentivized Payment, Phase 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ramp-down Payment, Phase 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Raffle Payment, Phase 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Weight, Low Activity Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Weight, High Activity Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kevin Short, PhD, Associate Professor
University of Oklahoma Health Sciences Center
Phone: (405) 271-8001
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place