Skip to main content
OpenTrials
Completed

NCT Number: NCT03141151

Competency-based Approaches to Community Health

This study is a family-centered, community-based intervention to prevent and treat childhood obesity among 3-5 year old children from undeserved communities. Half of participants will receive a healthy lifestyle intervention and half of participants will receive a school-readiness intervention.

Completed

Looking for future studies?

Notify Me

Key information

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

About this study

The complex multi-level determinants of childhood obesity necessitate a personalized approach. One of the main challenges to effective behavior change interventions is the complexity of the systems in which these behaviors are situated. Namely, health behaviors are the result of the confluence of macro-level influences (e.g., the built environment, family, etc.) and micro-level influences (e.g., stress). Furthermore, it is imperative that attempts to support healthy childhood growth consider the foundational contribution of a person's culture to their health behaviors, especially as children from traditionally underserved minorities are often hardest hit by obesity.

This program will test a 15 week behavioral intervention followed by 3 months of coaching calls that uses principles from the learning sciences and health behavior change to help shape healthy behaviors in the context of family. The follow-up of the study will last 1 year. The content of the intervention will focus on health behavior change, including teaching goal-setting and self monitoring skills, as well as parenting strategies.

The primary outcome of interest will be early childhood BMI trajectory over 1 year. Additional measures will include survey data to measure parent and child health behaviors (e.g., diet, physical activity, sleep, media use) that are associated with obesity.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Three-to-five year old child
  • Spanish or English-speaking
  • Child's BMI ≥ 50%
  • Parental commitment to participate in a year long study
  • Consistent phone access
  • Parent age ≥ 18 years
  • Child completion of baseline data collection on height, weight, and waist circumference and all willing survey items completed by the parent
  • Parents and children must be healthy (parents with controlled medical conditions will also be eligible).
  • Dyad must be considered underserved which will be indicated by the parents self-reporting if they or someone in their household participate in one of these programs or services: TennCare, CoverKids, WIC, Food Stamps (SNAP), Free and Reduced Price School Lunch and Breakfast, Families First (TANF), and/or subsidized housing

Treatment and study plan

COACH: Healthy Bodies

Behavioral

Staged intensity behavioral intervention focusing on healthy lifestyles in the context of family.

COACH: Strong Minds

Behavioral

School Readiness Intervention focusing on literacy and parent skills

Primary outcomes

  1. Change in Child Body Mass Index

    Time frame: Baseline, 4 months, 7 months, 1 year

    child BMI trajectory across 12 months; BMI differences over time are estimates from the longitudinal mixed-effects regression model

Secondary outcomes

  1. Child Diet: Soda

    Time frame: 4 months

    Parent-reported survey data; Child diet: Soda was measured by a single survey item used in the Feeding Infants and Toddlers Study with higher values representing higher frequency of consumption per day. (citation: Ziegler P, Briefel R, Clusen N, et al. Feeding Infants and Toddlers Study (FITS): Development of the FITS survey in comparison to other dietary survey methods. J Am Diet Assoc 2006;106:S12-S27.)

  2. Child Physical Activity

    Time frame: 4 months

    Parent-reported survey data

  3. Parent BMI

    Time frame: 4 months

  4. Parent Diet Practices

    Time frame: 4 months

    Self-reported survey data; Parent diet practices were measured by using a summed score of a 4-item questionnaire of eating behaviors, including overeating, unplanned eating, making poor food choices, and emotional eating. Higher scores represent more unhealthy parent dieting practices. Items ranged on a scale from 0-5 and were summed to create the scale which ranged from 0-20.

  5. Parenting Practices: Engagement

    Time frame: 4 months

    Self-reported survey data; Parenting practices around child physical activity were measured by the Preschooler Physical Activity Parenting Practices (PPAPP) scale which has an engagement subscale. Parenting practices: Engagement was a 15 item subscale of the PPAPP survey with higher scores representing higher parent engagement practices. Items ranged on a scale from 1-5 and were summed to create the subscale which ranged from 15-75.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Acronym: COACH

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 4, 2017
Registry last updated
Mar 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.