Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Pediatric Obesity
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Hybrid-implementation effectiveness design incorporating a delayed-treatment design for treatment group assignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 6 years and 12 years
Gender
Both males and females

Description

The U.S. Preventive Services Task Force (USPSTF) recently reissued a Grade B recommendation, initially made in 2010, for clinicians to screen children ages 6-18 years for obesity and refer identified youth to comprehensive, multi-component programs with >26 contact hours that include nutrition and p...

The U.S. Preventive Services Task Force (USPSTF) recently reissued a Grade B recommendation, initially made in 2010, for clinicians to screen children ages 6-18 years for obesity and refer identified youth to comprehensive, multi-component programs with >26 contact hours that include nutrition and physical activity targets and are supported by behavioral strategies. Re-issue of this recommendation highlights the continued importance of comprehensive family-based obesity treatment programs with broad accessibility. The challenge in meeting this objective is the lack of community-based obesity treatments for children. The majority of children in the U.S. do not receive evidence-based treatment of obesity, with few such programs available to youth from low-income backgrounds. There are multiple efforts underway to broaden both the empirical support for, and accessibility of, pediatric weight management interventions. One such strategy is implementation within the primary care setting as families are already accustomed to attending visits for medical concerns and because physicians are important drivers of health behavior change. An alternative strategy, also with high impact potential, is embedding interventions in established organizations within the communities in which families live, thereby decreasing logistical barriers (e.g. transportation) and enhancing program credibility. The JOIN for ME program, developed as a collaboration between United HealthGroup and Y-USA, is an empirically tested, effective pediatric weight control intervention for children ages 6-12 years that is delivered by facilitators within a community setting and potentially scalable nationally. The primary aim of this study is to test the effectiveness of the the JOIN for ME intervention in two different types of community setting, housing authorities and patient-centered medical homes, with the intention to increase equity and access to care for families in low-income settings. To accomplish this aim, formative qualitative work was conducted during 2019-2020 with key community stakeholders and families within the targeted community settings. The formative work resulted in adapting "participant facing" intervention materials and tools as well as the development of systems to connect families with local community resources. These developments will be implemented in intervention delivery as a means of increasing acceptability of the intervention and assessing its potential for broader scale dissemination within community settings. Further, certified Community Health Workers (CHWs) will deliver the proposed intervention given their ability to serve as intermediaries between healthcare systems and the community. A total of 128 children (ages 6-12) with BMI > 85th% will be enrolled in this study and receive the JOIN for ME weight control intervention. Participants will be assigned to active or delayed treatment conditions (4-month delay) based on an a priori set of rules pertaining to recruitment strategies and timeline. Evaluation of primary outcomes, change in child and parent weight status and health-related quality of life (HRQL), will be obtained at baseline, 4 months, and 10 months. The following hypotheses will be tested: Children who receive the JOIN for ME program immediately will demonstrate greater decreases in percent over median BMI and zBMI from baseline to 4 months compared to those in the delayed treatment onset prior to receiving the intervention. Children who receive the JOIN for ME program immediately will demonstrate improvements in HRQL from baseline to 4 months compared to those in the delayed treatment onset.

Tracking Information

NCT #
NCT04647760
Collaborators
  • Brown University
  • University of North Carolina, Chapel Hill
  • Tufts University
  • Brandeis University
Investigators
Principal Investigator: Elissa Jelalian, PhD The Miriam Hospital