Packaging and Disseminating the JOIN for ME Program in Low-Income Settings

NCT04647760 | Completed DMC

• 1 other identifier: 5U18DP006429-02
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

One in five children in the United States have obesity, and under-served populations are differentially impacted by both obesity and its related health consequences. Thus, community-based programs that improve the dissemination of effective obesity treatments are needed within low income settings. The current study aims to test the effectiveness of an evidence-based, community centered program, JOIN for ME, in two types of community settings: housing authorities and patient-centered medical homes. Children between the ages of 6-12 years old and who meet study eligibility criteria will be enrolled in the study and participate in the JOIN for ME weight control intervention. Participants will be assigned to active or delayed treatment conditions (4-month delay) but all participants will receive the JOIN for ME program. The program will be delivered in English or Spanish. Primary outcomes include change in child and parent weight status and health-related quality of life.

Conditions

Pediatric Obesity

Keywords

Pediatric; Pediatric obesity; Pediatric overweight; Community-based; Behavioral weight loss

Outcome Measures

Primary Outcomes (4)

• Patient Outcome - Change in child weight status

  Change in Body Mass Index (BMI, kg/m2)-for age-percentile

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

• Patient Outcome - Change in parent weight status

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

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

• Patient Outcome - Change in child health-related quality of life (HRQL)

  Obesity-specific child self-report measure, Size Me Up

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

• Patient Outcome - Change in parent health-related quality of life (HRQL)

  Obesity-specific parent self-report measure, Sizing Them Up

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

Study Arms (2)

Active treatment

OTHER

Participants will start the intervention immediately upon study enrollment.

Behavioral: JOIN for ME

Delayed treatment

OTHER

Participants will start the intervention 4-months post enrollment.

Behavioral: JOIN for ME

Interventions

JOIN for ME BEHAVIORAL

JOIN for ME is an empirically tested, effective weight management program for children ages 6-12 years.The curriculum includes 16 weekly in person sessions followed by 4 biweekly and 4 monthly maintenance sessions for a 10-month program. Weekly meetings are attended by the parent/caregiver and child, and occur at a location within their community setting (public housing or patient-centered medical home). Each session is 60 minutes and led by a certified Community Health Worker, with a private weigh-in for each dyad prior to the start of each session. Key behavioral targets include self-monitoring of dietary intake and physical activity, limiting LESS foods, limiting screen time, and weekly attendance. A family-based incentive structure is incorporated into the program such that parents/caregivers reinforce their children for achieving goals. Due to the COVID-19 pandemic, in-person sessions will be conducted virtually until it is safe to resume in-person group sessions.

Active treatment; Delayed treatment

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• be 6 to 12 years old
• have a BMI \> 85th percentile
• have at least one caregiver available to provide consent and participate in sessions
• speak English or Spanish
• agree to study participation and delayed treatment onset if applicable.

You may not qualify if:

• either the child or the parent is currently involved in another weight loss program
• have a medical condition that would interfere with the prescribed dietary plan or participation in physical activity
• are developmentally delayed such that the intervention materials will not be appropriate
• are in treatment for or diagnosed with a major psychiatric disorder, including an eating disorder

Sponsors & Collaborators

• The Miriam Hospital: lead
• Brown University: collaborator
• University of North Carolina, Chapel Hill: collaborator
• Tufts University: collaborator
• Brandeis University: collaborator

Study Sites (1)

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

Providence, Rhode Island, 02903, United States

Location

Related Publications (2)

• Darling KE, Hayes JF, Evans EW, Seifer R, Elwy AR, Jelalian E. Implementation of the JOIN for ME Program for Families from Low-Income Backgrounds: The Use of Theory-Driven Formative Evaluation: Rhode Island CORD 3.0. Child Obes. 2021 Sep;17(S1):S22-S29. doi: 10.1089/chi.2021.0172.

  PMID: 34569847 DERIVED

• Jelalian E, Evans W, Darling KE, Seifer R, Vivier P, Goldberg J, Wright C, Tanskey L, Warnick J, Hayes J, Shepard D, Tuttle H, Elwy AR. Protocol for the Rhode Island CORD 3.0 Study: Adapting, Testing, and Packaging the JOIN for ME Family-Based Childhood Obesity Program in Low-Income Communities. Child Obes. 2021 Sep;17(S1):S11-S21. doi: 10.1089/chi.2021.0179.

  PMID: 34569839 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elissa Jelalian, PhD

  The Miriam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor; Associate Director, Weight Control & Diabetes Research Center

Model Details: Hybrid-implementation effectiveness design incorporating a delayed-treatment design for treatment group assignment

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 1, 2020
• Study Start: January 25, 2021
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be submitted to a repository or otherwise made available within 12 months of completion of the grant or coincident with publication of a manuscript based on the study findings, whichever is sooner. Long-term preservation will be described once a repository/website for deidentified data has been identified and the details are known.
• Access Criteria: Access criteria will be provided once a repository/wesbite for deidentified data has been identified and the details are known.

Locations

US (1)