Financial Incentives to Exercise for Adolescents (MOVE)
2019년 3월 25일 업데이트: University of Oklahoma
Incentivizing Behavior: Promoting More Physical Activity in American Indian Youth
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.
연구 개요
상태
상태
완전한
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
중재적
등록 (실제)
등록
142
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Oklahoma
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Hugo, Oklahoma, 미국, 74743
- Choctaw Nation of Oklahoma Healthcare
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Talihina, Oklahoma, 미국, 74571
- Choctaw Nation Diabetes Wellness Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
11년 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
8
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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활성 비교기: 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.
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All participants will perform exercise training at the wellness center.
Exercise duration and intensity will be recorded with heart rate monitors.
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활성 비교기: 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.
|
All participants will perform exercise training at the wellness center.
Exercise duration and intensity will be recorded with heart rate monitors.
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활성 비교기: 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.
|
All participants will perform exercise training at the wellness center.
Exercise duration and intensity will be recorded with heart rate monitors.
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실험적: 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
|
All participants will perform exercise training at the wellness center.
Exercise duration and intensity will be recorded with heart rate monitors.
|
|
실험적: 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
|
All participants will perform exercise training at the wellness center.
Exercise duration and intensity will be recorded with heart rate monitors.
|
|
실험적: 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.
|
All participants will perform exercise training at the wellness center.
Exercise duration and intensity will be recorded with heart rate monitors.
|
|
간섭 없음: 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.
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간섭 없음: 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change From Baseline in Volume of Exercise (Total Time)
기간: at baseline (week 0) and weeks 16, 32, and 48.
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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).
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at baseline (week 0) and weeks 16, 32, and 48.
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Insulin Resistance
기간: at baseline (week 0) and weeks 16, 32, and 48.
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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.
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at baseline (week 0) and weeks 16, 32, and 48.
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Exercise Fitness
기간: at baseline (week 0) and weeks 16, 32, and 48.
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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.
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at baseline (week 0) and weeks 16, 32, and 48.
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Body Composition
기간: at baseline (week 0) and weeks 16, 32, and 48.
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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.
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at baseline (week 0) and weeks 16, 32, and 48.
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Physical Activity
기간: at baseline (week 0) and weeks 16, 32, and 48.
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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.
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at baseline (week 0) and weeks 16, 32, and 48.
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Blood Lipids
기간: at baseline (week 0) and weeks 16, 32, and 48.
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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.
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at baseline (week 0) and weeks 16, 32, and 48.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 수석 연구원: Kevin R Short, PhD, University of Oklahoma
- 수석 연구원: Kenneth C Copeland, MD, University of Oklahoma
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
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추가 정보
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