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Financial Incentives to Exercise for Adolescents (MOVE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Oklahoma
Sponsor:
Information provided by (Responsible Party):
Kevin Short, University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01848353
First received: April 25, 2013
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

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 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.


Condition Intervention
Insulin Resistance
Obesity
Sedentary Lifestyle
Behavioral: Exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Incentivizing Behavior: Promoting More Physical Activity in American Indian Youth

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Change from baseline in volume of exercise (total time) [ Time Frame: at baseline (week 0) and weeks 16, 32, and 48. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Insulin resistance [ Time Frame: at baseline (week 0) and weeks 16, 32, and 48. ] [ Designated as safety issue: No ]
    Fasting blood glucose and insulin concentration will be measured and used to calculate the homeostatic model of assessment for insulin resistance (HOMA-IR). 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.

  • Exercise fitness [ Time Frame: at baseline (week 0) and weeks 16, 32, and 48. ] [ Designated as safety issue: No ]
    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.

  • Body composition [ Time Frame: at baseline (week 0) and weeks 16, 32, and 48. ] [ Designated as safety issue: No ]
    Body fat and lean 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 Outcome Measures:
  • Physical activity [ Time Frame: at baseline (week 0) and weeks 16, 32, and 48. ] [ Designated as safety issue: No ]
    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.

  • Blood lipids [ Time Frame: at baseline (week 0) and weeks 16, 32, and 48. ] [ Designated as safety issue: No ]
    Standard assessment of fasting cholesterol, HDL-C, LDL-C, triglycerides, free fatty acids. 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.


Estimated Enrollment: 86
Study Start Date: May 2013
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

Study participants 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.

  Eligibility

Ages Eligible for Study:   11 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 11-17 years old
  • obese
  • family history of diabetes (primary or secondary relative)
  • not in sports or exercise program (3 or fewer days per week of MVPA)for prior 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01848353

Locations
United States, Oklahoma
Choctaw Nation of Oklahoma Healthcare Recruiting
Hugo, Oklahoma, United States, 74743
Contact: Kevin Short, PhD    405-271-8001 ext 43094    kevin-short@ouhsc.edu   
Principal Investigator: Kenneth C Copeland, MD         
Principal Investigator: Kevin R Short, PhD         
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Kevin R Short, PhD University of Oklahoma
Principal Investigator: Kenneth C Copeland, MD University of Oklahoma
  More Information

No publications provided

Responsible Party: Kevin Short, Assistant Professor, University of Oklahoma
ClinicalTrials.gov Identifier: NCT01848353     History of Changes
Other Study ID Numbers: P20 MD000528-RP2
Study First Received: April 25, 2013
Last Updated: September 9, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014