Recruiting
Phase 2

Weight Control

Sponsor:

The Miriam Hospital

Code:

NCT02426346

Conditions

Pediatric Obesity

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Accepted

Interventions

Behavioral weight control

Group-based physical activity

Group-based incentives

Parent-based incentives

Study Details

Brief summary:

Community-based programs are needed to improve dissemination of efficacious treatment for adolescent obesity. The current study aims to modify a community-based program, delivered through the YMCA, to increase its effectiveness with adolescents. Adolescents will be randomized to either a 16-week standard program (JOIN) or a targeted intervention tailored for adolescents (TEEN JOIN). Primary outcomes include changes in BMI, objectively measured physical activity, and self-efficacy, assessed at 4 months and 10 months following randomization.

Conditions

Pediatric Obesity

Study ID

NCT02426346

Start date

Sep, 2014

Status verified date

Apr, 2017

Completion date

Dec, 2017

Anticipated

Primary completion date

Jul, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

experimental: 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.

Interventions

Behavioral weight control

Prescription of diet \& physical activity and behavioral strategies for weight control

Group-based physical activity

Teens exercise for 60 minutes with their group

Group-based incentives

Adolescents earn reinforcements within group

Parent-based incentives

Adolescents earn reinforcements from their parents (outside of group)

Primary outcome measure

  • Change in Body Mass Index (BMI, kg/m2) [ Time Frame: Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months) ]

Central Contacts and Locations

Central contacts

Elissa Jelalian, PhD

401 793 9716elissa_jelalian@brown.edu

Locations

Weight Management and Diabetes Research Center, The Miriam Hospital/Alpert Medical School of Brown University

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Kim Mailloux, BS

401-793-8320kkent1@lifespan.org

More Information

Sponsor

The Miriam Hospital

Last update posted

Apr 21, 2017

Last verified

Apr, 2017

Keywords

  • Adolescent; Adolescent obesity; Community-based; Overweight

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Miriam Hospital on 2017-04-21.