NCT02426346

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 21, 2017

Status Verified

April 1, 2017

Enrollment Period

2.8 years

First QC Date

April 21, 2015

Last Update Submit

April 20, 2017

Conditions

Pediatric Obesity

Keywords

Adolescent; Adolescent obesity; Community-based; Overweight

Outcome Measures

Primary Outcomes (1)

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

    Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)

Secondary Outcomes (2)

  • Objective time spent in moderate and vigorous physical activity measured by the Senswear Mini (MINI) armband

    Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)

  • Self-Efficacy Questionnaire

    Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)

Study Arms (2)

JOIN FOR ME

ACTIVE COMPARATOR

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.

Behavioral: Behavioral weight controlBehavioral: Parent-based incentives

TEEN JOIN

EXPERIMENTAL

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.

Behavioral: Behavioral weight controlBehavioral: Group-based physical activityBehavioral: Group-based incentives

Interventions

Behavioral weight controlBEHAVIORAL

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

JOIN FOR METEEN JOIN
Group-based physical activityBEHAVIORAL

Teens exercise for 60 minutes with their group

TEEN JOIN
Group-based incentivesBEHAVIORAL

Adolescents earn reinforcements within group

TEEN JOIN
Parent-based incentivesBEHAVIORAL

Adolescents earn reinforcements from their parents (outside of group)

JOIN FOR ME

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Providence, Rhode Island, 02903, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31855057DERIVED

MeSH Terms

Conditions

Pediatric ObesityOverweight

Condition Hierarchy (Ancestors)

ObesityOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Elissa Jelalian, PhD

CONTACT

401 793 9716elissa_jelalian@brown.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 21, 2015

First Posted

April 24, 2015

Study Start

September 1, 2014

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

April 21, 2017

Record last verified: 2017-04

Locations

US(1)