Competency-based Approaches to Community Health

Not Applicable

Completed

• Conditions: Obesity, Childhood

• Registration Number: NCT03141151
• Lead Sponsor: Vanderbilt University Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-05-01
• Study First Submitted QC: 2017-05-03
• Study First Posted: 2017-05-04
• Study Start: 2017-05-16
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Results First Submitted: 2019-08-30
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-05
• Last Update Submitted: 2020-03-05
• Results First Posted: 2020-03-20
• Last Update Posted: 2020-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

1. Three-to-five year old child
2. Spanish or English-speaking
3. Child's BMI ≥ 50%
4. Parental commitment to participate in a year long study
5. Consistent phone access
6. Parent age ≥ 18 years
7. Child completion of baseline data collection on height, weight, and waist circumference and all willing survey items completed by the parent
8. Parents and children must be healthy (parents with controlled medical conditions will also be eligible).
9. 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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Child Body Mass Index	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 Outcome Measures

Name	Time	Method
Child Physical Activity	4 months	Parent-reported survey data
Parent Diet Practices	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.
Parenting Practices: Engagement	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.
Child Diet: Soda	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.)
Parent BMI	4 months

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States