Clinical Trials Directory

Trials / Completed

CompletedNCT03141151

Competency-based Approaches to Community Health

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
117 (actual)
Sponsor
Vanderbilt University Medical Center · Academic / Other
Sex
All
Age
3 Years – 5 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCOACH: Healthy BodiesStaged intensity behavioral intervention focusing on healthy lifestyles in the context of family.
BEHAVIORALCOACH: Strong MindsSchool Readiness Intervention focusing on literacy and parent skills

Timeline

Start date
2017-05-16
Primary completion
2018-08-31
Completion
2018-08-31
First posted
2017-05-04
Last updated
2020-03-20
Results posted
2020-03-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03141151. Inclusion in this directory is not an endorsement.