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Competency Based Approaches for Community Health 2 (COACH)

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COACH
School Readiness Intervention
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Childhood Obesity, Behavioral Intervention, Parent-Child Pairs, Low-Income, Minority Populations, Hispanic/Latino Populations

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 <40 kg/m2, establishing risk for obesity without existing severe obesity;
  • include a child with a body mass index ≥5th percentile percentile for age and gender on standardized CDC growth curves;
  • reside within 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)
  • 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 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 ≥40kg/m2 (as that degree of morbid obesity represents a different phenotype where behavioral intervention alone may not be sufficient to achieve weight loss)
  • 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

Sites / Locations

  • Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

COACH Intervention

Educational Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Child Body Mass Index
Measured prospectively and calculated from child weight/height measures

Secondary Outcome Measures

Parent Body Mass Index
Measured prospectively and calculated from parent weight/height measures
Child Obesity
Percent of children with BMI ≥95th percentile on standardized CDC growth curves
Child Overweight
Percent of children with BMI percentile ≥85th but less than <95th percentile on standardized CDC growth curves
Child Body Mass Index Percentage of the 95th Percentile
Child BMI percentage of the 95th percentile on standardized CDC growth curves
Child Body Mass Index z-Scores
Child BMI z-scores on standardized CDC growth reference charts

Full Information

First Posted
October 26, 2020
Last Updated
April 12, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
National Institutes of Health (NIH), University of North Carolina, Chapel Hill, Vanderbilt University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04971044
Brief Title
Competency Based Approaches for Community Health 2
Acronym
COACH
Official Title
COACH: Competency Based Approaches for Community Health 2
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 18, 2021 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
National Institutes of Health (NIH), University of North Carolina, Chapel Hill, Vanderbilt University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Childhood Obesity, Behavioral Intervention, Parent-Child Pairs, Low-Income, Minority Populations, Hispanic/Latino Populations

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
COACH Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Educational Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
COACH
Intervention Description
Multi-Level Behavioral Intervention
Intervention Type
Behavioral
Intervention Name(s)
School Readiness Intervention
Intervention Description
Multi-Level Language and School Readiness Intervention (Control Group)
Primary Outcome Measure Information:
Title
Child Body Mass Index
Description
Measured prospectively and calculated from child weight/height measures
Time Frame
24-month follow-up
Secondary Outcome Measure Information:
Title
Parent Body Mass Index
Description
Measured prospectively and calculated from parent weight/height measures
Time Frame
24-month follow-up
Title
Child Obesity
Description
Percent of children with BMI ≥95th percentile on standardized CDC growth curves
Time Frame
24-month follow-up
Title
Child Overweight
Description
Percent of children with BMI percentile ≥85th but less than <95th percentile on standardized CDC growth curves
Time Frame
24-month follow-up
Title
Child Body Mass Index Percentage of the 95th Percentile
Description
Child BMI percentage of the 95th percentile on standardized CDC growth curves
Time Frame
24-month follow-up
Title
Child Body Mass Index z-Scores
Description
Child BMI z-scores on standardized CDC growth reference charts
Time Frame
24-month follow-up
Other Pre-specified Outcome Measures:
Title
Child Diet
Description
Parent reported diet quality based on survey measures
Time Frame
24-month follow-up
Title
Parent Diet
Description
Self-report diet quality based on survey measures
Time Frame
24-month follow-up
Title
Parent Physical Activity
Description
Parent reported physical activity for themselves based on survey measures
Time Frame
24-month follow-up
Title
Child Media Use
Description
Parent reported media use by child based on survey measures
Time Frame
24-month follow-up
Title
Child Sleep
Description
Parent reported sleep times based on survey measures
Time Frame
24-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 <40 kg/m2, establishing risk for obesity without existing severe obesity; 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 ≥40kg/m2 (as that degree of morbid obesity represents a different phenotype where behavioral intervention alone may not be sufficient to achieve weight loss) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
William J Heerman, MD MPH
Phone
615-322-7080
Email
Bill.Heerman@vumc.org
First Name & Middle Initial & Last Name or Official Title & Degree
LauraBeth Adams, RD, MBA
Phone
615-875-7298
Email
laura.e.adams@vumc.org
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Heerman, MD MPH
Phone
615-322-7080
Email
Bill.Heerman@vanderbilt.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We will plan to upload a de-identified dataset to the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH) database (this upload also includes study protocols).
IPD Sharing 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.
IPD Sharing Access Criteria
Determined by NIH DASH website
IPD Sharing URL
https://dash.nichd.nih.gov/

Learn more about this trial

Competency Based Approaches for Community Health 2

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