Obesity Clinical Trial
— MOVEOfficial title:
Incentivizing Behavior: Promoting More Physical Activity in American Indian Youth
NCT number | NCT01848353 |
Other study ID # | P20 MD000528-RP2 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2013 |
Est. completion date | May 2017 |
Verified date | March 2019 |
Source | University of Oklahoma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Choctaw Nation of Oklahoma Healthcare | Hugo | Oklahoma |
United States | Choctaw Nation Diabetes Wellness Center | Talihina | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
University of Oklahoma |
United States,
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. |
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