Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Financial Incentives to Exercise for Adolescents (MOVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01848353
Recruitment Status : Completed
First Posted : May 7, 2013
Results First Posted : March 14, 2019
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

Tracking Information
First Submitted Date  ICMJE April 25, 2013
First Posted Date  ICMJE May 7, 2013
Results First Submitted Date  ICMJE April 10, 2018
Results First Posted Date  ICMJE March 14, 2019
Last Update Posted Date April 3, 2019
Actual Study Start Date  ICMJE May 2013
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2013)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2018)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2013)
  • Oral glucose tolerance [ Time Frame: at baseline (week 0) and weeks 16, 32, and 48. ]
    Blood glucose and insulin responses to standard oral glucose challenge. 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. ]
    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. ]
    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.
Current Other Pre-specified Outcome Measures
 (submitted: November 21, 2018)
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: May 6, 2013)
  • 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.
  • Blood Lipids [ Time Frame: at baseline (week 0) and weeks 16, 32, and 48. ]
    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.
 
Descriptive Information
Brief Title  ICMJE Financial Incentives to Exercise for Adolescents
Official Title  ICMJE Incentivizing Behavior: Promoting More Physical Activity in American Indian Youth
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Insulin Resistance
  • Obesity
  • Sedentary Lifestyle
Intervention  ICMJE Behavioral: Exercise training
All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Exercise training
  • 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.
    Intervention: Behavioral: Exercise training
  • 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.
    Intervention: Behavioral: Exercise training
  • 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
    Intervention: Behavioral: Exercise training
  • 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
    Intervention: Behavioral: Exercise training
  • 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.
    Intervention: Behavioral: Exercise training
  • 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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2017)
142
Original Estimated Enrollment  ICMJE
 (submitted: May 6, 2013)
86
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01848353
Other Study ID Numbers  ICMJE P20 MD000528-RP2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Oklahoma
Study Sponsor  ICMJE University of Oklahoma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kevin R Short, PhD University of Oklahoma
Principal Investigator: Kenneth C Copeland, MD University of Oklahoma
PRS Account University of Oklahoma
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP