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A Scalable Weight Control Intervention for Adolescents (TEEN JOIN)

Primary Purpose

Pediatric Obesity

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Behavioral weight control
Group-based physical activity
Group-based incentives
Parent-based incentives
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obesity focused on measuring Adolescent; Adolescent obesity; Community-based; Overweight

Eligibility Criteria

13 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

JOIN FOR ME

TEEN JOIN

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Body Mass Index (BMI, kg/m2)

Secondary Outcome Measures

Objective time spent in moderate and vigorous physical activity measured by the Senswear Mini (MINI) armband
Objectively-measured moderate and vigorous physical activity
Self-Efficacy Questionnaire
Adolescents' confidence in their ability to lose weight and engage in physical activity

Full Information

First Posted
April 21, 2015
Last Updated
April 20, 2017
Sponsor
The Miriam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02426346
Brief Title
A Scalable Weight Control Intervention for Adolescents
Acronym
TEEN JOIN
Official Title
TEEN JOIN: A Scalable Weight Control Intervention for Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Miriam Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
Keywords
Adolescent; Adolescent obesity; Community-based; Overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
JOIN FOR ME
Arm Type
Active Comparator
Arm Description
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.
Arm Title
TEEN JOIN
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral weight control
Intervention Description
Prescription of diet & physical activity and behavioral strategies for weight control
Intervention Type
Behavioral
Intervention Name(s)
Group-based physical activity
Intervention Description
Teens exercise for 60 minutes with their group
Intervention Type
Behavioral
Intervention Name(s)
Group-based incentives
Intervention Description
Adolescents earn reinforcements within group
Intervention Type
Behavioral
Intervention Name(s)
Parent-based incentives
Intervention Description
Adolescents earn reinforcements from their parents (outside of group)
Primary Outcome Measure Information:
Title
Change in Body Mass Index (BMI, kg/m2)
Time Frame
Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)
Secondary Outcome Measure Information:
Title
Objective time spent in moderate and vigorous physical activity measured by the Senswear Mini (MINI) armband
Description
Objectively-measured moderate and vigorous physical activity
Time Frame
Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)
Title
Self-Efficacy Questionnaire
Description
Adolescents' confidence in their ability to lose weight and engage in physical activity
Time Frame
Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elissa Jelalian, PhD
Phone
401 793 9716
Email
elissa_jelalian@brown.edu
Facility Information:
Facility Name
Weight Management and Diabetes Research Center, The Miriam Hospital/Alpert Medical School of Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Mailloux, BS
Phone
401-793-8320
Email
kkent1@lifespan.org

12. IPD Sharing Statement

Citations:
PubMed Identifier
31855057
Citation
Jelalian E, Evans EW, Rancourt D, Ranzenhofer L, Taylor N, Hart C, Seifer R, Klinepier K, Foster GD. JOIN for ME: Testing a Scalable Weight Control Intervention for Adolescents. Child Obes. 2020 Apr;16(3):192-203. doi: 10.1089/chi.2019.0053. Epub 2019 Dec 18.
Results Reference
derived

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A Scalable Weight Control Intervention for Adolescents

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