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Completed

NCT Number: NCT01848353

Financial Incentives to Exercise for Adolescents

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.

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Key information

Age range

11 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Choctaw Nation of Oklahoma Healthcare, Hugo, Oklahoma, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Training

Behavioral

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

Primary outcomes

  1. Change From Baseline in Volume of Exercise (Total Time)

    Time frame: at baseline (week 0) and weeks 16, 32, and 48.

    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).

Secondary outcomes

  1. Insulin Resistance

    Time frame: at baseline (week 0) and weeks 16, 32, and 48.

    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.

  2. Exercise Fitness

    Time frame: at baseline (week 0) and weeks 16, 32, and 48.

    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.

  3. Body Composition

    Time frame: at baseline (week 0) and weeks 16, 32, and 48.

    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.

Other outcomes

  1. Physical Activity

    Time frame: at baseline (week 0) and weeks 16, 32, and 48.

    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.

  2. Blood Lipids

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

Incentivizing Behavior: Promoting More Physical Activity in American Indian Youth

Acronym: MOVE

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
May 7, 2013
Registry last updated
Apr 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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