A Scalable Weight Control Intervention for Adolescents (TEEN JOIN)
TEEN JOIN: A Scalable Weight Control Intervention for Adolescents
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Rhode Island
-
Providence、Rhode Island、アメリカ、02903
- 募集
- Weight Management and Diabetes Research Center, The Miriam Hospital/Alpert Medical School of Brown University
-
コンタクト:
- Kim Mailloux, BS
- 電話番号:401-793-8320
- メール:kkent1@lifespan.org
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ: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.
|
Prescription of diet & physical activity and behavioral strategies for weight control
Adolescents earn reinforcements from their parents (outside of group)
|
|
実験的: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.
|
Prescription of diet & physical activity and behavioral strategies for weight control
Teens exercise for 60 minutes with their group
Adolescents earn reinforcements within group
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change in Body Mass Index (BMI, kg/m2)
時間枠:Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)
|
Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Objective time spent in moderate and vigorous physical activity measured by the Senswear Mini (MINI) armband
時間枠:Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)
|
Objectively-measured moderate and vigorous physical activity
|
Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)
|
|
Self-Efficacy Questionnaire
時間枠:Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)
|
Adolescents' confidence in their ability to lose weight and engage in physical activity
|
Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)
|
協力者と研究者
スポンサー
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Behavioral weight controlの臨床試験
-
University Hospital, Ghent完了
-
University of Rochester完了肥満 | 太りすぎ | 健康的な生活様式 | 心血管リスク | 実装研究アメリカ
-
Medical University of South CarolinaWeight Watchers International完了
-
The Miriam HospitalUniversity of Tennessee; Weight Watchers International完了
-
Semra TUNCAY YILMAZSemra TUNCAY YILMAZ完了
-
University of Southern MississippiMilitary Suicide Research Consortium招待による登録
-
Square2 Systems, Inc.National Institute on Drug Abuse (NIDA)積極的、募集していない