- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02426346
A Scalable Weight Control Intervention for Adolescents (TEEN JOIN)
TEEN JOIN: A Scalable Weight Control Intervention for Adolescents
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
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Rhode Island
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Providence, Rhode Island, Spojené státy, 02903
- Nábor
- Weight Management and Diabetes Research Center, The Miriam Hospital/Alpert Medical School of Brown University
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Kontakt:
- Kim Mailloux, BS
- Telefonní číslo: 401-793-8320
- E-mail: kkent1@lifespan.org
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: 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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Experimentální: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Change in Body Mass Index (BMI, kg/m2)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Objective time spent in moderate and vigorous physical activity measured by the Senswear Mini (MINI) armband
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 1R34DK10098101A1
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