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Financial Incentives to Exercise for Adolescents (MOVE)

Primary Purpose

Insulin Resistance, Obesity, Sedentary Lifestyle

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise training
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Insulin Resistance

Eligibility Criteria

11 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Choctaw Nation of Oklahoma Healthcare
  • Choctaw Nation Diabetes Wellness Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Active Comparator

Active Comparator

Experimental

Experimental

Experimental

No Intervention

No Intervention

Arm Label

Standard payment, phase 1

Standard payment, phase 2

Ramp-down payment, phase 3

Incentivized payment, phase 1

Incentivized payment, phase 2

Raffle payment, phase 3

Normal weight, low activity group

Normal weight, high activity group

Arm 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.

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.

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.

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

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

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
April 25, 2013
Last Updated
March 25, 2019
Sponsor
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT01848353
Brief Title
Financial Incentives to Exercise for Adolescents
Acronym
MOVE
Official Title
Incentivizing Behavior: Promoting More Physical Activity in American Indian Youth
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Obesity, Sedentary Lifestyle

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard payment, phase 1
Arm Type
Active Comparator
Arm 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.
Arm Title
Standard payment, phase 2
Arm Type
Active Comparator
Arm 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.
Arm Title
Ramp-down payment, phase 3
Arm Type
Active Comparator
Arm 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.
Arm Title
Incentivized payment, phase 1
Arm Type
Experimental
Arm 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
Arm Title
Incentivized payment, phase 2
Arm Type
Experimental
Arm 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
Arm Title
Raffle payment, phase 3
Arm Type
Experimental
Arm 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.
Arm Title
Normal weight, low activity group
Arm Type
No Intervention
Arm 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.
Arm Title
Normal weight, high activity group
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Intervention Description
All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
Primary Outcome Measure Information:
Title
Change From Baseline in Volume of Exercise (Total Time)
Description
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).
Time Frame
at baseline (week 0) and weeks 16, 32, and 48.
Secondary Outcome Measure Information:
Title
Insulin Resistance
Description
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.
Time Frame
at baseline (week 0) and weeks 16, 32, and 48.
Title
Exercise Fitness
Description
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.
Time Frame
at baseline (week 0) and weeks 16, 32, and 48.
Title
Body Composition
Description
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.
Time Frame
at baseline (week 0) and weeks 16, 32, and 48.
Other Pre-specified Outcome Measures:
Title
Physical Activity
Description
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.
Time Frame
at baseline (week 0) and weeks 16, 32, and 48.
Title
Blood Lipids
Description
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.
Time Frame
at baseline (week 0) and weeks 16, 32, and 48.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin R Short, PhD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kenneth C Copeland, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
Choctaw Nation of Oklahoma Healthcare
City
Hugo
State/Province
Oklahoma
ZIP/Postal Code
74743
Country
United States
Facility Name
Choctaw Nation Diabetes Wellness Center
City
Talihina
State/Province
Oklahoma
ZIP/Postal Code
74571
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29856832
Citation
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.
Results Reference
derived

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Financial Incentives to Exercise for Adolescents

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