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Competency Based Approaches for Community Health 2

COACH: Competency Based Approaches for Community Health 2

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04971044
Acronym
COACH
Enrollment
301
Registered
2021-07-21
Start date
2021-11-18
Completion date
2026-10-31
Last updated
2025-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

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

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.

Interventions

BEHAVIORALCOACH

Multi-Level Behavioral Intervention

BEHAVIORALSchool Readiness Intervention

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Child Body Mass Index24-month follow-upMeasured prospectively and calculated from child weight/height measures

Secondary

MeasureTime frameDescription
Child Body Mass Index z-Scores24-month follow-upChild BMI z-scores on standardized CDC growth reference charts
Parent Body Mass Index24-month follow-upMeasured prospectively and calculated from parent weight/height measures
Child Obesity24-month follow-upPercent of children with BMI ≥95th percentile on standardized CDC growth curves
Child Overweight24-month follow-upPercent of children with BMI percentile ≥85th but less than \<95th percentile on standardized CDC growth curves
Child Body Mass Index Percentage of the 95th Percentile24-month follow-upChild BMI percentage of the 95th percentile on standardized CDC growth curves

Other

MeasureTime frameDescription
Parent Diet24-month follow-upSelf-report diet quality based on survey measures
Parent Physical Activity24-month follow-upParent reported physical activity for themselves based on survey measures
Child Media Use24-month follow-upParent reported media use by child based on survey measures
Child Sleep24-month follow-upParent reported sleep times based on survey measures
Child Diet24-month follow-upParent reported diet quality based on survey measures

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026