Financial Incentives to Exercise for Adolescents (MOVE)

University of Oklahoma (OU)

Status: Completed

Conditions: Insulin Resistance; Obesity; Sedentary Lifestyle

Treatments: Behavioral: Exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT01848353

P20 MD000528-RP2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 142 patients

Sex: All

Ages: 11 to 20 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 8 patient groups

Standard payment, phase 1

Active Comparator 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.

Treatment:

Behavioral: Exercise training

Standard payment, phase 2

Active Comparator 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 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.

Treatment:

Behavioral: Exercise training

Ramp-down payment, phase 3

Active Comparator group

Description:

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.

Treatment:

Behavioral: Exercise training

Incentivized payment, phase 1

Experimental group

Description:

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

Treatment:

Behavioral: Exercise training

Incentivized payment, phase 2

Experimental group

Description:

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

Treatment:

Behavioral: Exercise training

Raffle payment, phase 3

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise training

Normal weight, low activity group

No Intervention group

Description:

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 group

Description:

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.