Clinical trial NCT04647760: Packaging and Disseminating the JOIN for ME Program in Low-Income Settings
Official title: Packaging and Disseminating the JOIN for ME Program in Low-Income Settings
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pediatric Obesity
Keywords: Pediatric
Pediatric obesity
Pediatric overweight
Community-based
Behavioral weight loss
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: Brown University
name: University of North Carolina, Chapel Hill
name: Tufts University
name: Brandeis University
First posted: 2020-12-01
Enrollment: 111
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Hybrid-implementation effectiveness design incorporating a delayed-treatment design for treatment group assignment
Primary purpose: TREATMENT

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.

Detailed 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 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. The intervention will be delivered in English or Spanish. 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:

1. 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.
2. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Patient Outcome - Change in child weight status
timeFrame: Baseline, post-intensive treatment 1 (4 months), post-maintenance treatment 2 (10 months)
measure: Patient Outcome - Change in parent weight status
timeFrame: Baseline, post-intensive treatment 1 (4 months), post-maintenance treatment 2 (10 months)
measure: Patient Outcome - Change in child health-related quality of life (HRQL)
timeFrame: Baseline, post-intensive treatment 1 (4 months), post-maintenance treatment 2 (10 months)
measure: Patient Outcome - Change in parent health-related quality of life (HRQL)
timeFrame: Baseline, post-intensive treatment 1 (4 months), post-maintenance treatment 2 (10 months)
Secondary outcomes:
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:
affiliation: The Miriam Hospital
name: Elissa Jelalian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.