Competency Based Approaches for Community Health 2

NCT04971044 | Active Not Recruiting DMC

• 2 other identifiers: 1R01HD1004583R01HD100458-03S1
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Childhood Obesity; Behavioral Intervention; Parent-Child Pairs; Low-Income, Minority Populations; Hispanic/Latino Populations

Outcome Measures

Primary Outcomes (1)

• Child Body Mass Index

  Measured prospectively and calculated from child weight/height measures

  24-month follow-up

Secondary Outcomes (5)

• Parent Body Mass Index

  24-month follow-up

• Child Obesity

  24-month follow-up

• Child Overweight

  24-month follow-up

• Child Body Mass Index Percentage of the 95th Percentile

  24-month follow-up

• Child Body Mass Index z-Scores

  24-month follow-up

Other Outcomes (5)

• Child Diet

  24-month follow-up

• Parent Diet

  24-month follow-up

• Parent Physical Activity

  24-month follow-up

Study Arms (2)

COACH Intervention

EXPERIMENTAL

COACH is a multi-level intervention, consisting of 1) developmentally appropriate health curriculum for 4-6 year old children; 2) family-based content that both targets parent weight loss and leverages a shared parent-child experience to improve family health behaviors; 3) community-level intervention to improve access and quality of family-based programming at local Parks and Rec centers.

Behavioral: COACH

Educational Control

ACTIVE COMPARATOR

The control arm will consist of a school readiness intervention developed by education and literacy experts on our team and implemented at local libraries. It will include 1) child lessons from Puente de Cuentos, a systematic, language-based curriculum focused on dual language storytelling (narrative language), and 2) parent sessions designed to improve parents' knowledge and skills related to improving children's language production and storytelling skills, to ultimately support school readiness.

Behavioral: School Readiness Intervention

Interventions

COACH BEHAVIORAL

Multi-Level Behavioral Intervention

COACH Intervention

School Readiness Intervention BEHAVIORAL

Multi-Level Language and School Readiness Intervention (Control Group)

Educational Control

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• are without medical conditions necessitating limited physical activity as evaluated by a pre-screen;
• complete baseline data collection, including parent and child height and weight and at least 90% of baseline survey items;
• are considered underserved, measured by parent-self reporting that they or someone in their household are eligible for or participate in one of these programs or services: TennCare, CoverKids, WIC, Food Stamps (SNAP), Free and Reduced Price School Lunch and Breakfast, and/or Families First (TANF)

You may not qualify if:

• Children outside the specified age range
• Children who are \<5th percentile on standardized CDC growth curves
• Children who do not speak English or Spanish
• Children who are diagnosed with medical illnesses where regular exercise might be contraindicated
• Children who display dissenting behaviors during baseline assent or anthropometric data collection
• Children who do not otherwise meet the eligibility criteria listed in section above as determined by pre-screen
• Children who are diagnosed with autism
• Parents/legal guardians who are \<18 years old;
• Parents/legal guardians with serious mental or neurologic illness that impairs ability to consent/participate;
• Parents/legal guardians with poor visual acuity (corrected vision worse than 20/50 with Rosenbaum Screener).
• Parents/legal guardians with BMI \<25kg/m2 or BMI ≥55kg/m2
• Parents/legal guardians who are diagnosed with medical illnesses where regular exercise might be contraindicated
• Lack of parental commitment to participate consistently for a two-year period
• Lack of telephone contact
• Parents/legal guardians who do not otherwise meet the eligibility criteria listed in section above as determined by pre-screen

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institutes of Health (NIH): collaborator
• University of North Carolina, Chapel Hill: collaborator
• Vanderbilt University: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Obesity; Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: July 21, 2021
• Study Start: November 18, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: In accordance with NIH policy, we will make these data available no later than 3 years after the end of the trial (final patient follow-up) or 2 years after the main paper of the trial has been published, whichever comes first.
• Access Criteria: Determined by NIH DASH website

Locations

US (1)