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Clinical Trials/NCT04971044
NCT04971044
Active, not recruiting
Not Applicable

COACH: Competency Based Approaches for Community Health 2

Vanderbilt University Medical Center1 site in 1 country301 target enrollmentNovember 18, 2021
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Vanderbilt University Medical Center
Enrollment
301
Locations
1
Primary Endpoint
Child Body Mass Index
Status
Active, not recruiting
Last Updated
5 months ago

Overview

Brief Summary

One-size-fits-all approaches have failed to demonstrate sustained effects on childhood obesity, especially among low-income minority families, who experience constantly changing barriers to engaging in health behavior. Addressing obesity in these populations requires intervening in early childhood and situating interventions in the context of families and communities. Developing personalized childhood obesity prevention interventions with sustained effectiveness that support families in health behaviors despite dynamic barriers could address chronic disease risk and health disparities in low-income and minority communities.

Detailed Description

Despite the recognition of health disparities in obesity, behavioral interventions among low-income and minority populations have consistently met with limited success. This is partially explained by social determinants of health. Constantly changing barriers at the household and community levels impede consistent engagement in healthy behaviors. The current proposal tests a novel, culturally-tailored and multi-level intervention designed to teach families to overcome dynamic barriers as the logical next step to address obesity among low-income Latino families. It is based on the premise that by implementing a personalized multi-level intervention that simultaneously addresses healthy weight for parents and children, we will improve body mass index (BMI) among Latino parent-child pairs. COACH (COmpetency-Based Approaches to Community Health) implements a personally tailored approach, equipping families to engage in health behaviors despite dynamic barriers. COACH is a multi-level intervention targeting 1) the individual child through developmentally appropriate health behavior curriculum, 2) the family by addressing parent weight loss directly and engaging parents as agents of change for their children, and 3) the community by building capacity of Parks and Rec centers to offer parent-child programming. Using novel multi-component assessments throughout the study, the intervention identifies individual, family, and community barriers to healthy behaviors and delivers structured yet personalized intervention content in 7 domains: fruits/vegetables, snacks, sugary drinks, physical activity, sleep, media use, and parenting. Building on a successful pilot, this proposal will implement a randomized controlled trial to test the effectiveness of COACH compared to an attention-matched school-readiness control group. We will enroll 300 parent-child pairs from Latino communities in Nashville, TN. The goals of COACH are to 1) implement a novel personalized behavioral intervention, 2) test a two-generation solution to obesity, 3) address health disparities by reducing obesity among Latino families, and 4) develop a scalable and widely accessible approach to behavioral obesity interventions by delivering them in Parks and Rec centers.

Registry
clinicaltrials.gov
Start Date
November 18, 2021
End Date
October 1, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bill Heerman

Assistant Professor of Pediatrics

Vanderbilt University Medical Center

Eligibility Criteria

Inclusion Criteria

  • child with an age ≥4 years and \<7 years;
  • index parent/legal guardian with an age ≥18 years;
  • English- or Spanish-speaking;
  • self-identify as Hispanic/Latino;
  • live in a home where Spanish is spoken;
  • include an index parent/legal guardian with a body mass index of ≥25kg/m2 and \<55 kg/m2;
  • include a child with a body mass index ≥5th percentile percentile for age and gender on standardized CDC growth curves;
  • for participants intending to attend intervention sessions in person: reside within or frequent (i.e. work in or regularly visit) one of the following zip codes: South Nashville/Regions 1 and 2 (37013, 37204, 37210, 37211, 37217, 37220, 37076, 37086, 37167): surrounding the Coleman Recreation Center and Southeast Recreation Center; and Northeast Nashville/Madison/Region 3 (37115, 37138, 37072, 37207, 37216); for participants intending to attend intervention sessions via videoconference: participants may reside in any zip code;
  • have parental commitment to participate in a two-year research study;
  • have consistent mobile phone access;

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Child Body Mass Index

Time Frame: 24-month follow-up

Measured prospectively and calculated from child weight/height measures

Secondary Outcomes

  • Parent Body Mass Index(24-month follow-up)
  • Child Body Mass Index Percentage of the 95th Percentile(24-month follow-up)
  • Child Obesity(24-month follow-up)
  • Child Overweight(24-month follow-up)
  • Child Body Mass Index z-Scores(24-month follow-up)

Study Sites (1)

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