Financial Incentives to Exercise for Adolescents (MOVE)

• ClinicalTrials.gov Identifier: NCT01848353
• Recruitment Status: Completed
• First Posted: May 7, 2013
• Results First Posted: March 14, 2019
• Last Update Posted: April 3, 2019
• Sponsor: University of Oklahoma
• Information provided by (Responsible Party): University of Oklahoma

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other
• Conditions: Insulin Resistance; Obesity; Sedentary Lifestyle
• Intervention: Behavioral: Exercise training
• Enrollment: 142

Participant Flow

Recruitment Details	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.
Pre-assignment Details	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.

Arm/Group Title	Standard Payment	Incentivized Payment	Normal Weight, Low Activity Group	Normal Weight, High Activity Group
Arm/Group Description	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.	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.	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.	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.
Period Title: Phase 1
Started	38	43	20	19
Completed	35	42	20	19
Not Completed	3	1	0	0
Reason Not Completed
Withdrawal by Subject	3	1	0	0
Period Title: Phase 2
Started	23 [1]	28 [1]	0 [2]	0 [2]
Completed	20	26	0	0
Not Completed	3	2	0	0
Reason Not Completed
Withdrawal by Subject	3	2	0	0
[1] 26 participants from Phase 1 intervention (both groups) withdrew and did not complete Phase 2; [2] Normal weight participants only completed baseline testing in Phase 1.
Period Title: Phase 3
Started	5 [1]	10 [1]	0 [2]	0 [2]
Completed	4	9	0	0
Not Completed	1	1	0	0
Reason Not Completed
Withdrawal by Subject	1	1	0	0
[1] 31 participants from Phase 2 intervention (both groups) withdrew and did not complete Phase 3; [2] Normal weight participants only completed baseline testing in Phase 1.

Baseline Characteristics

Arm/Group Title		Standard Payment, Phase 1	Incentivized Payment, Phase 1	Normal Weight, Low Activity Group	Normal Weight, High Activity Group	Total
Arm/Group Description		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.	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.	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.	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 of all reporting groups
Overall Number of Baseline Participants		38	43	20	19	120
Baseline Analysis Population Description		Normal weight groups completed only the baseline testing. The overweight/obese group entered the exercise program at phase 1, and then continued on to phases 2 and 3 if they remained enrolled.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	38 participants	43 participants	20 participants	19 participants	120 participants
		13.8 (2.2)	14.2 (2.2)	14.6 (2.3)	14.3 (1.9)	14.4 (2.3)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	38 participants	43 participants	20 participants	19 participants	120 participants
	Female	21 55.3%	25 58.1%	11 55.0%	7 36.8%	64 53.3%
	Male	17 44.7%	18 41.9%	9 45.0%	12 63.2%	56 46.7%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	38 participants	43 participants	20 participants	19 participants	120 participants
	American Indian or Alaska Native	38 100.0%	43 100.0%	20 100.0%	19 100.0%	120 100.0%
	Asian	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	White	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	38 participants	43 participants	20 participants	19 participants	120 participants
		38	43	20	19	186
Body mass index; Mean (Standard Deviation); Unit of measure: Kg/m^2
	Number Analyzed	38 participants	43 participants	20 participants	19 participants	120 participants
		33.4 (7.0)	34.8 (6.1)	20.8 (1.9)	20.1 (2.4)	30.1 (9.0)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Volume of Exercise (Total Time)
Description	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).
Time Frame	at baseline (week 0) and weeks 16, 32, and 48.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Standard Payment, Phase 1	Incentivized Payment, Phase 1	Standard Payment, Phase 2	Incentivized Payment, Phase 2	Ramp-down Payment, Phase 3	Raffle Payment, Phase 3
Arm/Group Description:	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.	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.	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.	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.	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.	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.
Overall Number of Participants Analyzed	35	42	20	26	4	9
Mean (Standard Deviation); Unit of Measure: hours
	15.2 (10.1)	15.0 (8.1)	8.0 (5.5)	12.4 (11.1)	10.2 (3.8)	8.8 (4.7)

2. Secondary Outcome

Title	Insulin Resistance
Description	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.
Time Frame	at baseline (week 0) and weeks 16, 32, and 48.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Standard Payment, Phase 1	Incentivized Payment, Phase 1	Standard Payment, Phase 2	Incentivized Payment, Phase 2	Ramp-down Payment, Phase 3	Raffle Payment, Phase 3	Normal Weight, Low Activity Group	Normal Weight, High Activity Group
Arm/Group Description:	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.	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.	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.	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.	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.	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.	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.	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.
Overall Number of Participants Analyzed	25	32	9	11	4	6	20	19
Mean (Standard Deviation); Unit of Measure: % of sensitivity
	75 (49)	69 (44)	66 (36)	77 (45)	57 (28)	65 (35)	170 (75)	179 (92)

3. Secondary Outcome

Title	Exercise Fitness
Description	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.
Time Frame	at baseline (week 0) and weeks 16, 32, and 48.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Standard Payment, Phase 1	Incentivized Payment, Phase 1	Standard Payment, Phase 2	Incentivized Payment, Phase 2	Ramp-down Payment, Phase 3	Raffle Payment, Phase 3	Normal Weight, Low Activity Group	Normal Weight, High Activity Group
Arm/Group Description:	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.	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.	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.	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.	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.	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.	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.	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.
Overall Number of Participants Analyzed	24	31	9	11	4	6	19	19
Mean (Standard Deviation); Unit of Measure: ml/kg fat free mass/minute
	36.9 (8.0)	37.4 (8.6)	39.0 (10.8)	39.2 (12.9)	39.2 (5.8)	43.0 (6.6)	61.7 (7.5)	45.1 (5.4)

4. Secondary Outcome

Title	Body Composition
Description	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.
Time Frame	at baseline (week 0) and weeks 16, 32, and 48.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Standard Payment, Phase 1	Incentivized Payment, Phase 1	Standard Payment, Phase 2	Incentivized Payment, Phase 2	Ramp-down Payment, Phase 3	Raffle Payment, Phase 3	Normal Weight, Low Activity Group	Normal Weight, High Activity Group
Arm/Group Description:	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.	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.	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.	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.	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.	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.	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.	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.
Overall Number of Participants Analyzed	25	32	9	11	4	6	19	19
Mean (Standard Deviation); Unit of Measure: Total body fat percentage
	43.9 (7.8)	44.4 (7.7)	40.8 (4.4)	40.9 (7.1)	40.4 (3.5)	44.9 (9.1)	21.2 (6.3)	23.3 (7.7)

5. Other Pre-specified Outcome

Title	Physical Activity
Description	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.
Time Frame	at baseline (week 0) and weeks 16, 32, and 48.

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Standard Payment, Phase 1	Incentivized Payment, Phase 1	Standard Payment, Phase 2	Incentivized Payment, Phase 2	Ramp-down Payment, Phase 3	Raffle Payment, Phase 3	Normal Weight, Low Activity Group	Normal Weight, High Activity Group
Arm/Group Description:	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.	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.	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.	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.	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.	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.	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.	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.
Overall Number of Participants Analyzed	21	27	7	8	3	4	19	18
Mean (Standard Deviation); Unit of Measure: steps per day
	6048 (2711)	6028 (3136)	4862 (1217)	6787 (4273)	4166 (1882)	6863 (2321)	9492 (3176)	8338 (3103)

6. Other Pre-specified Outcome

Title	Blood Lipids
Description	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.
Time Frame	at baseline (week 0) and weeks 16, 32, and 48.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Standard Payment, Phase 1	Incentivized Payment, Phase 1	Standard Payment, Phase 2	Incentivized Payment, Phase 2	Ramp-down Payment, Phase 3	Raffle Payment, Phase 3	Normal Weight, Low Activity Group	Normal Weight, High Activity Group
Arm/Group Description:	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.	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.	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.	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.	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.	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.	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.	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.
Overall Number of Participants Analyzed	25	32	9	11	4	6	20	19
Mean (Standard Deviation); Unit of Measure: mg/dl
	92 (56)	97 (68)	64 (30)	114 (87)	83 (50)	102 (80)	51 (24)	60 (30)

Adverse Events

Time Frame	Adverse events were monitored for each participant for as long as they were actively enrolled in the study, a period of up to 48 weeks for the exercise intervention group.
Adverse Event Reporting Description	Injury or illness due to exercise performed as part of the study
Arm/Group Title	Standard Payment, Phase 1	Incentivized Payment, Phase 1	Standard Payment, Phase 2	Incentivized Payment, Phase 2	Ramp-down Payment, Phase 3	Raffle Payment, Phase 3	Normal Weight, Low Activity Group	Normal Weight, High Activity Group
Arm/Group Description	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.	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.	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.	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.	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.	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.	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.	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.
All-Cause Mortality
	Standard Payment, Phase 1	Incentivized Payment, Phase 1	Standard Payment, Phase 2	Incentivized Payment, Phase 2	Ramp-down Payment, Phase 3	Raffle Payment, Phase 3	Normal Weight, Low Activity Group	Normal Weight, High Activity Group
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/38 (0.00%)	0/43 (0.00%)	0/23 (0.00%)	0/28 (0.00%)	0/5 (0.00%)	0/10 (0.00%)	0/20 (0.00%)	0/19 (0.00%)
Serious Adverse Events
	Standard Payment, Phase 1	Incentivized Payment, Phase 1	Standard Payment, Phase 2	Incentivized Payment, Phase 2	Ramp-down Payment, Phase 3	Raffle Payment, Phase 3	Normal Weight, Low Activity Group	Normal Weight, High Activity Group
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/38 (0.00%)	0/43 (0.00%)	0/23 (0.00%)	0/28 (0.00%)	0/5 (0.00%)	0/10 (0.00%)	0/20 (0.00%)	0/19 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Standard Payment, Phase 1	Incentivized Payment, Phase 1	Standard Payment, Phase 2	Incentivized Payment, Phase 2	Ramp-down Payment, Phase 3	Raffle Payment, Phase 3	Normal Weight, Low Activity Group	Normal Weight, High Activity Group
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/38 (0.00%)	0/43 (0.00%)	0/23 (0.00%)	0/28 (0.00%)	0/5 (0.00%)	0/10 (0.00%)	0/20 (0.00%)	0/19 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Kevin Short, PhD, Associate Professor
• Organization: University of Oklahoma Health Sciences Center
• Phone: (405) 271-8001 ext 43094
• EMail: kevin-short@ouhsc.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Short KR, Chadwick JQ, Cannady TK, Branam DE, Wharton DF, Tullier MA, Thompson DM, Copeland KC. Using financial incentives to promote physical activity in American Indian adolescents: A randomized controlled trial. PLoS One. 2018 Jun 1;13(6):e0198390. doi: 10.1371/journal.pone.0198390. eCollection 2018. Erratum in: PLoS One. 2020 Mar 25;15(3):e0231075.

• Responsible Party: University of Oklahoma
• ClinicalTrials.gov Identifier: NCT01848353
• Other Study ID Numbers: P20 MD000528-RP2
• First Submitted: April 25, 2013
• First Posted: May 7, 2013
• Results First Submitted: April 10, 2018
• Results First Posted: March 14, 2019
• Last Update Posted: April 3, 2019