- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00285558
Peer-enhanced Intervention to Support Teen Weight Loss
Peer-Enhanced Intervention to Support Teen Weight Loss
연구 개요
상세 설명
The prevalence of overweight in children and adolescents has increased significantly during the last two decades. While there are empirically supported weight management interventions for school age children, treatment findings with overweight adolescents are not as consistent. A potential limitation of weight control interventions for adolescents is the minimal attention given to the peer group as an active component of treatment. We have promising findings from a pilot study that involves adding an innovative peer-based intervention (peer-based skills training; PBST) to cognitive- behavioral weight management treatment for adolescents. The purpose of the proposed study is to expand the pilot by: 1) increasing our sample size, 2) assessing weight loss over a longer time period, and 3) evaluating the role of psychosocial variables, as well as physical activity and diet, in mediating treatment outcome. It is hypothesized that overweight adolescents randomized to cognitive-behavioral treatment with peer enhancement will demonstrate greater weight loss at long term follow-up than adolescents randomized to cognitive-behavioral treatment with exercise.
One hundred and fifty adolescents between the ages of 13 and 16 years and 20% and 90% overweight will be randomized to one of two treatment conditions: 1) Cognitive-Behavioral Weight Loss Treatment with Peer-Based Skills Training (CBT+PBST) or 2) Cognitive-Behavioral Weight Loss Treatment with Exercise (CBT+EXER). Measures of height, weight, physical activity, diet, and psychosocial functioning will be obtained at baseline, end of treatment, 12 months, and 24 months after randomization. A between-groups t-test will be conducted to evaluate group differences in change in percent overweight between baseline and 24-month follow-up. Hierarchical linear modeling will be used to assess the pattern of weight loss for the two treatment groups across four time points: baseline, end of treatment, 12 month, and 24 month follow-up. Effects of treatment on psychosocial measures will be analyzed using mixed analysis of variance with treatment condition as the between subjects factor and a within subject factor of time. Finally, a series of regression analyses will be conducted to evaluate the role of psychosocial variables, physical activity, and diet, as mediators of treatment outcome.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Rhode Island
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Providence, Rhode Island, 미국, 02903
- Bradley Hasbro Children's Research Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adolescents 13-16 years old
- 20-90% overweight with reference gender and age
- At least 1 parent who can participate
- English speaking
- Agree to study participation and random assignment
- Be available for long-term follow-up
Exclusion Criteria:
- Current involvement in another weight loss program
- Unable to adhere to prescribed dietary plan and physical activity due to medical condition
- Unable to understand intervention materials
- In treatment for or diagnosed with psychiatric disorder
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: CBT with peer-enhanced activities
Cognitive behavioral treatment (CBT) with peer-enhanced adventure therapy.
The peer intervention, ''adventure therapy,'' is based on the principles of Outward Bound and was expected to affect weight status through a positive effect on self-concept.
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활성 비교기: CBT with supervised aerobic exercise
Cognitive behavioral treatment (CBT) with supervised aerobic exercise.
Activities for the supervised exercise intervention included use of treadmills, stationary bicycles, and other aerobic activities selected by participants, including dance videos and brisk walking within the clinic setting.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Change in Adolescent Body Mass Index (BMI)
기간: 12 and 24 months
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12 and 24 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Self concept
기간: 12 and 24 months
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Self- Perception Profile for Adolescents and the Physical Self-Worth Scale
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12 and 24 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Elissa Jelalian, PhD, Brown University Medical School; Lifespan Corporation
간행물 및 유용한 링크
일반 간행물
- Rancourt D, Barker DH, Jelalian E. Sex as a Moderator of Adolescents' Weight Loss Treatment Outcomes. J Adolesc Health. 2018 May;62(5):591-597. doi: 10.1016/j.jadohealth.2017.12.002. Epub 2018 Mar 7.
- Jelalian E, Lloyd-Richardson EE, Mehlenbeck RS, Hart CN, Flynn-O'Brien K, Kaplan J, Neill M, Wing RR. Behavioral weight control treatment with supervised exercise or peer-enhanced adventure for overweight adolescents. J Pediatr. 2010 Dec;157(6):923-928.e1. doi: 10.1016/j.jpeds.2010.05.047. Epub 2010 Jul 23.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .