Financial Incentives to Exercise for Adolescents (MOVE)

Incentivizing Behavior: Promoting More Physical Activity in American Indian Youth

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 Overview

• Status: Completed
• Conditions: Obesity; Sedentary Lifestyle; Insulin Resistance
• Intervention / Treatment: Behavioral: Exercise training

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Hugo, Oklahoma, United States, 74743
      • Choctaw Nation of Oklahoma Healthcare
    • Talihina, Oklahoma, United States, 74571
      • Choctaw Nation Diabetes Wellness Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria for exercise intervention cohort:

• 11.0-20.9 years old
• overweight or obese
• family history of diabetes (primary or secondary relative)
• not in sports or exercise program (3 or fewer days per week of moderate-to-vigorous intensity physical activity, MVPA) for prior 3 months
• Tanner stage 2 or above

Inclusion Criteria for reference group cohort:

• 11.0-20.9 years old
• normal weight
• For low physical activity subgroup: not in sports or exercise program (3 or fewer days per week of MVPA) for prior 3 months
• For high physical activity subgroup: >30 minutes of structured MVPA on >3 days/week over the preceding 3 months
• Tanner stage 2 or above

Exclusion Criteria for all participants:

• metabolic, endocrine, cardiovascular, kidney disease
• orthopedic problems that limit physical activity
• medications or treatments that would interfere with the outcomes and interpretations
• smoking or tobacco use
• alcohol or illicit drug use
• pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: Exercise training; All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
Active Comparator: 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.	Behavioral: Exercise training; All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
Active Comparator: 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.	Behavioral: Exercise training; All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
Experimental: 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	Behavioral: Exercise training; All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
Experimental: 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	Behavioral: Exercise training; All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
Experimental: 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.	Behavioral: Exercise training; All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
No Intervention: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.
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.

Other Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Kevin R Short, PhD, University of Oklahoma; Principal Investigator: Kenneth C Copeland, MD, University of Oklahoma

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: April 25, 2013
• First Submitted That Met QC Criteria: May 6, 2013
• First Posted (Estimate): May 7, 2013

Study Record Updates

• Last Update Posted (Actual): April 3, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: P20 MD000528-RP2