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| ID | Type | Description | Link |
|---|---|---|---|
| P20MD000528 | U.S. NIH Grant/Contract | View source |
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Among youth populations, American Indians have the highest prevalence of diabetes in the United States. This study will use exercise as the principal lifestyle modification approach to reduce the risk of diabetes in this population. The Choctaw Nation of Oklahoma has several excellent, but underutilized wellness facilities in their Health Services Area in rural Southeast Oklahoma, a low socioeconomic region. It has been established that exercise lowers diabetes risk, and many overweight/obese, insulin resistant American Indian youth who live in this region would benefit from an increase in regular exercise. The challenge is to modify behavior so that routine exercise is established and maintained. The proposed study will test whether monetary incentives can elicit greater frequency and duration of exercise in American Indian youth when transportation and access barriers are reduced.
Study participants in the intervention arm of the study will be asked to exercise on 3 days per week for 48 weeks. Clinical and physical assessments will be performed at baseline and after 16, 32 and 48 weeks. Participants will be randomized into one of two groups. Each group will receive payment for exercise sessions completed but one group will be on a fixed schedule of compensation and the other will have a schedule that incentivizes frequency or duration of exercise. In addition, two reference groups of age-matched participants who are normal weight and subclassified as having either low or high levels of physical activity and fitness will be tested. The reference groups will complete baseline tests and will not enter the exercise intervention program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard payment, phase 1 | Active Comparator | 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. |
|
| Standard payment, phase 2 | Active Comparator | 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. |
|
| Ramp-down payment, phase 3 | Active Comparator | 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. |
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| Incentivized payment, phase 1 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise training | Behavioral | All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Volume of Exercise (Total Time) | 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). | at baseline (week 0) and weeks 16, 32, and 48. |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Resistance | 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. | at baseline (week 0) and weeks 16, 32, and 48. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity | 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. | at baseline (week 0) and weeks 16, 32, and 48. |
| Blood Lipids |
Inclusion Criteria for exercise intervention cohort:
Inclusion Criteria for reference group cohort:
Exclusion Criteria for all participants:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin R Short, PhD | University of Oklahoma | Principal Investigator |
| Kenneth C Copeland, MD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Choctaw Nation of Oklahoma Healthcare | Hugo | Oklahoma | 74743 | United States | ||
| Choctaw Nation Diabetes Wellness Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29856832 | Derived | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 |
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| Phase 2 |
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| Phase 3 |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Payment, Phase 1 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Volume of Exercise (Total Time) | 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). | 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. | Posted | Mean | Standard Deviation | hours | at baseline (week 0) and weeks 16, 32, and 48. |
|
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.
Injury or illness due to exercise performed as part of the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Payment, Phase 1 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Short, PhD, Associate Professor | University of Oklahoma Health Sciences Center | (405) 271-8001 | 43094 | kevin-short@ouhsc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 4, 2016 | Nov 12, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D009765 | Obesity |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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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
|
| Incentivized payment, phase 2 | Experimental | 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 |
|
| Raffle payment, phase 3 | Experimental | 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. |
|
| Normal weight, low activity group | No Intervention | 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 | No Intervention | 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 | 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. | at baseline (week 0) and weeks 16, 32, and 48. |
| Body Composition | 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. | at baseline (week 0) and weeks 16, 32, and 48. |
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. |
| at baseline (week 0) and weeks 16, 32, and 48. |
| Talihina |
| Oklahoma |
| 74571 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| BG001 | Incentivized Payment, Phase 1 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Standard Payment, Phase 1 |
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. |
| OG001 | Incentivized Payment, Phase 1 | 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. |
| OG002 | Standard Payment, Phase 2 | 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. |
| OG003 | Incentivized Payment, Phase 2 | 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. |
| OG004 | Ramp-down Payment, Phase 3 | 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. |
| OG005 | Raffle Payment, Phase 3 | 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. |
|
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| Secondary | Insulin Resistance | 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. | 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. | Posted | Mean | Standard Deviation | % of sensitivity | at baseline (week 0) and weeks 16, 32, and 48. |
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| Secondary | Exercise Fitness | 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. | 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. | Posted | Mean | Standard Deviation | ml/kg fat free mass/minute | at baseline (week 0) and weeks 16, 32, and 48. |
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| Secondary | Body Composition | 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. | 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. | Posted | Mean | Standard Deviation | Total body fat percentage | at baseline (week 0) and weeks 16, 32, and 48. |
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| Other Pre-specified | Physical Activity | 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. | 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). | Posted | Mean | Standard Deviation | steps per day | at baseline (week 0) and weeks 16, 32, and 48. |
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| Other Pre-specified | Blood Lipids | 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. | 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. | Posted | Mean | Standard Deviation | mg/dl | at baseline (week 0) and weeks 16, 32, and 48. |
|
|
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| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Incentivized Payment, Phase 1 | 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. | 0 | 43 | 0 | 43 | 0 | 43 |
| EG002 | Standard Payment, Phase 2 | 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. | 0 | 23 | 0 | 23 | 0 | 23 |
| EG003 | Incentivized Payment, Phase 2 | 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. | 0 | 28 | 0 | 28 | 0 | 28 |
| EG004 | Ramp-down Payment, Phase 3 | 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. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG005 | Raffle Payment, Phase 3 | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG006 | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG007 | 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. | 0 | 19 | 0 | 19 | 0 | 19 |
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| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |