Clinical trial NCT01848353: Financial Incentives to Exercise for Adolescents
Official title: Incentivizing Behavior: Promoting More Physical Activity in American Indian Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Obesity
Sedentary Lifestyle
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2013-05-07
Enrollment: 142
Sex: ALL
Minimum age (years): 11
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change From Baseline in Volume of Exercise (Total Time)
timeFrame: at baseline (week 0) and weeks 16, 32, and 48.
Secondary outcomes:
measure: Insulin Resistance
timeFrame: at baseline (week 0) and weeks 16, 32, and 48.
measure: Exercise Fitness
timeFrame: at baseline (week 0) and weeks 16, 32, and 48.
measure: Body Composition
timeFrame: at baseline (week 0) and weeks 16, 32, and 48.
Other outcomes:
measure: Physical Activity
timeFrame: at baseline (week 0) and weeks 16, 32, and 48.
measure: Blood Lipids
timeFrame: at baseline (week 0) and weeks 16, 32, and 48.
Locations:
city: Hugo
country: United States
facility: Choctaw Nation of Oklahoma Healthcare
state: Oklahoma
city: Talihina
country: United States
facility: Choctaw Nation Diabetes Wellness Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Kevin R Short, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oklahoma
name: Kenneth C Copeland, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.