Clinical trial NCT04971044: Competency Based Approaches for Community Health 2
Official title: COACH: Competency Based Approaches for Community Health 2
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Childhood Obesity
Behavioral Intervention
Parent-Child Pairs
Low-Income, Minority Populations
Hispanic/Latino Populations
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: University of North Carolina, Chapel Hill
name: Vanderbilt University
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-07-21
Enrollment: 301
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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;
* 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

Primary outcomes:
measure: Child Body Mass Index
timeFrame: 24-month follow-up
Secondary outcomes:
measure: Parent Body Mass Index
timeFrame: 24-month follow-up
measure: Child Obesity
timeFrame: 24-month follow-up
measure: Child Overweight
timeFrame: 24-month follow-up
measure: Child Body Mass Index Percentage of the 95th Percentile
timeFrame: 24-month follow-up
measure: Child Body Mass Index z-Scores
timeFrame: 24-month follow-up
Other outcomes:
measure: Child Diet
timeFrame: 24-month follow-up
measure: Parent Diet
timeFrame: 24-month follow-up
measure: Parent Physical Activity
timeFrame: 24-month follow-up
measure: Child Media Use
timeFrame: 24-month follow-up
measure: Child Sleep
timeFrame: 24-month follow-up
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References: