Financial Incentives to Exercise for Adolescents

NCT ID: NCT01848353

Last Updated: 2019-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2017-05-31

Brief Summary

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.

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.

Conditions

Insulin Resistance; Obesity; Sedentary Lifestyle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Exercise training

Intervention Type: BEHAVIORAL

All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

Standard payment, phase 2

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.

Group Type: ACTIVE_COMPARATOR

Exercise training

Intervention Type: BEHAVIORAL

All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

Ramp-down payment, phase 3

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.

Group Type: ACTIVE_COMPARATOR

Exercise training

Intervention Type: BEHAVIORAL

All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

Incentivized payment, phase 1

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

Group Type: EXPERIMENTAL

Exercise training

Intervention Type: BEHAVIORAL

All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

Incentivized payment, phase 2

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

Group Type: EXPERIMENTAL

Exercise training

Intervention Type: BEHAVIORAL

All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

Raffle payment, phase 3

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.

Group Type: EXPERIMENTAL

Exercise training

Intervention Type: BEHAVIORAL

All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

Normal weight, low activity group

This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have low physical activity and fitness like the intervention group. Therefore differences in their results with the intervention group will reflect the effects of overweight/obesity on the variables of interest.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise training

All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin R Short, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Kenneth C Copeland, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

Choctaw Nation of Oklahoma Healthcare

Hugo, Oklahoma, United States

Choctaw Nation Diabetes Wellness Center

Talihina, Oklahoma, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29856832 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

P20MD000528

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P20 MD000528-RP2

Identifier Type: -

Identifier Source: org_study_id