Competency Based Approaches for Community Health 2

Obesity Clinical Trial

— COACH  

Official title:

COACH: Competency Based Approaches for Community Health 2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04971044
• Other study ID #: 1R01HD100458
• Secondary ID: 3R01HD100458-03S
• Status: Recruiting
• Phase: N/A
• Start date: November 18, 2021
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: Vanderbilt University Medical Center
• Contact: William J Heerman, MD MPH
• Phone: 615-322-7080
• Email: Bill.Heerman[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years and older

Eligibility

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;
• 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)

Child exclusion criteria:

• 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

Caregiver exclusion criteria include:

• 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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• COACH
Multi-Level Behavioral Intervention
• School Readiness Intervention
Multi-Level Language and School Readiness Intervention (Control Group)

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (5)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), University of North Carolina, Chapel Hill, Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Child Diet	Parent reported diet quality based on survey measures	24-month follow-up
Other	Parent Diet	Self-report diet quality based on survey measures	24-month follow-up
Other	Parent Physical Activity	Parent reported physical activity for themselves based on survey measures	24-month follow-up
Other	Child Media Use	Parent reported media use by child based on survey measures	24-month follow-up
Other	Child Sleep	Parent reported sleep times based on survey measures	24-month follow-up
Primary	Child Body Mass Index	Measured prospectively and calculated from child weight/height measures	24-month follow-up
Secondary	Parent Body Mass Index	Measured prospectively and calculated from parent weight/height measures	24-month follow-up
Secondary	Child Obesity	Percent of children with BMI =95th percentile on standardized CDC growth curves	24-month follow-up
Secondary	Child Overweight	Percent of children with BMI percentile =85th but less than <95th percentile on standardized CDC growth curves	24-month follow-up
Secondary	Child Body Mass Index Percentage of the 95th Percentile	Child BMI percentage of the 95th percentile on standardized CDC growth curves	24-month follow-up
Secondary	Child Body Mass Index z-Scores	Child BMI z-scores on standardized CDC growth reference charts	24-month follow-up