Financial Incentives to Exercise for Adolescents

Obesity Clinical Trial

— MOVE  

Official title:

Incentivizing Behavior: Promoting More Physical Activity in American Indian Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01848353
• Other study ID #: P20 MD000528-RP2
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: May 2017

Study information

• Verified date: March 2019
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity
• Sedentary Lifestyle

Intervention

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

Locations

Country	Name	City	State
United States	Choctaw Nation of Oklahoma Healthcare	Hugo	Oklahoma
United States	Choctaw Nation Diabetes Wellness Center	Talihina	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical Activity	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.	at baseline (week 0) and weeks 16, 32, and 48.
Other	Blood Lipids	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.	at baseline (week 0) and weeks 16, 32, and 48.
Primary	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).	at baseline (week 0) and weeks 16, 32, and 48.
Secondary	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.	at baseline (week 0) and weeks 16, 32, and 48.
Secondary	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.	at baseline (week 0) and weeks 16, 32, and 48.
Secondary	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.	at baseline (week 0) and weeks 16, 32, and 48.