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Clinical Trials/NCT03141151
NCT03141151
Completed
N/A

Competency-based Approaches to Community Health

Vanderbilt University Medical Center1 site in 1 country117 target enrollmentMay 16, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obesity, Childhood
Sponsor
Vanderbilt University Medical Center
Enrollment
117
Locations
1
Primary Endpoint
Change in Child Body Mass Index
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 16, 2017
End Date
August 31, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bill Heerman

Assistant Professor of Pediatrics

Vanderbilt University Medical Center

Eligibility Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • Child Physical Activity(4 months)
  • Parent Diet Practices(4 months)
  • Parenting Practices: Engagement(4 months)
  • Child Diet: Soda(4 months)
  • Parent BMI(4 months)

Study Sites (1)

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