Clinical trial NCT02426346: A Scalable Weight Control Intervention for Adolescents
Official title: TEEN JOIN: A Scalable Weight Control Intervention for Adolescents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pediatric Obesity
Keywords: Adolescent; Adolescent obesity; Community-based; Overweight
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2015-04-24
Enrollment: 120
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Body Mass Index (BMI, kg/m2)
timeFrame: Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)
Secondary outcomes:
measure: Objective time spent in moderate and vigorous physical activity measured by the Senswear Mini (MINI) armband
timeFrame: Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)
measure: Self-Efficacy Questionnaire
timeFrame: Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)
Other outcomes:
Locations:
city: Providence
country: United States
facility: Weight Management and Diabetes Research Center, The Miriam Hospital/Alpert Medical School of Brown University
state: Rhode Island
Study officials:
References:
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.