- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02426346
A Scalable Weight Control Intervention for Adolescents (TEEN JOIN)
TEEN JOIN: A Scalable Weight Control Intervention for Adolescents
연구 개요
상태
정황
상세 설명
In 2010, the U.S. Preventive Services Task Force (USPSTF) provided a Grade recommendation B (i.e. the service is recommended with moderate/high certainty of benefit) for clinicians to screen children ages 6-17 years for obesity and refer identified youth to comprehensive behavioral programs. The challenge in meeting this objective is the lack of community-based obesity treatments to which to refer, particularly for adolescents. The JOIN program, developed as a collaboration between United HealthGroup and Y-USA is a pediatric weight control intervention targeted toward a broad age range of youth from 6-17 years that is: 1) based on well established and evidence based principles; 2) delivered by YMCA facilitators within a community setting: and 3) potentially scalable nationally. Findings from a 6-month pilot study examining the effectiveness of JOIN demonstrated impressive changes in weight status for school age children, but more modest results for adolescents. The primary aim of this study is to modify the JOIN program to increase its effectiveness with adolescents while retaining its potential for scalability.
A total of 120 adolescents (ages 13-17) with BMI > 85th% and < 50 will be randomly assigned to a 16-week targeted program (TEEN JOIN), or the traditional JOIN intervention, followed by biweekly and monthly maintenance sessions. Evaluation of adolescent height, weight, objective physical activity and psychosocial outcomes will be obtained at baseline, 4 months, and 10 months. Additional outcomes will include treatment feasibility, including attendance, completion of diet and physical activity monitoring logs, and exit interviews with adolescents and parents regarding the intervention. The investigators will also obtain preliminary indicators of cost effectiveness. It is hypothesized that adolescents who are randomized to TEEN JOIN will demonstrate greater decrease in BMI at 4 and 10 months than those randomized to JOIN. It is further hypothesized that adolescents randomized to TEEN JOIN will demonstrate greater increases in participation in moderate-vigorous physical activity and greater improvements in self-concept, self-efficacy related to physical activity, and group cohesion than adolescents who receive the standard JOIN condition.
연구 유형
등록 (예상)
단계
- 2 단계
연락처 및 위치
연구 장소
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Rhode Island
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Providence, Rhode Island, 미국, 02903
- 모병
- Weight Management and Diabetes Research Center, The Miriam Hospital/Alpert Medical School of Brown University
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연락하다:
- Kim Mailloux, BS
- 전화번호: 401-793-8320
- 이메일: kkent1@lifespan.org
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 13 to 17 years
- BMI > 85th percentile and absolute BMI < 50
- have at least one parent available to provide consent and participate in sessions
- speak English
- agree to study participation and random assignment
Exclusion Criteria:
- currently involved in another weight loss program
- have a medical condition that would interfere with the prescribed dietary plan or participation in physical activity
- developmentally delayed such that the intervention materials will not be appropriate
- in treatment for a major psychiatric disorder, including an eating disorder, or are diagnosed with a major psychiatric disorder at the time of screening.
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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활성 비교기: JOIN FOR ME
The JOIN for ME curriculum includes 16 weekly in person sessions followed by 4 biweekly and 4 monthly maintenance sessions for a 10-month program.
Weekly meetings are scheduled for 60 minutes and are facilitated by a YMCA coach.
Interventions include behavioral weight control and parent-based incentives.
Parents attend group at weeks 1, 2 and 16 with their teen.
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Prescription of diet & physical activity and behavioral strategies for weight control
Adolescents earn reinforcements from their parents (outside of group)
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실험적: TEEN JOIN
Similar to the JOIN FOR ME condition, adolescents in the TEEN JOIN condition attend 16 weekly in person sessions followed by 4 biweekly and 4 monthly maintenance sessions for a 10-month program.
Interventions include behavioral weight control, group-based physical activity, and group-based incentives.
Parents attend separate meetings at weeks 1, 2, and 16.
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Prescription of diet & physical activity and behavioral strategies for weight control
Teens exercise for 60 minutes with their group
Adolescents earn reinforcements within group
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Change in Body Mass Index (BMI, kg/m2)
기간: Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)
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Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Objective time spent in moderate and vigorous physical activity measured by the Senswear Mini (MINI) armband
기간: Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)
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Objectively-measured moderate and vigorous physical activity
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Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)
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Self-Efficacy Questionnaire
기간: Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)
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Adolescents' confidence in their ability to lose weight and engage in physical activity
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Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
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. .
Behavioral weight control에 대한 임상 시험
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University of North Carolina, Chapel HillWeight Watchers International완전한
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Medical University of South CarolinaWeight Watchers International완전한
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The Miriam HospitalUniversity of Tennessee; Weight Watchers International완전한
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Education University of Hong KongUniversity of Texas at Austin; City University of Hong Kong모병
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Gonzalo Jorquera, PhDUniversidad de Valparaiso완전한
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Anglia Ruskin UniversityDanone Global Research & Innovation Center완전한
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Hacettepe University아직 모집하지 않음