Competency-based Approaches to Community Health

Obesity, Childhood Clinical Trial

— COACH  

Official title:

Competency-based Approaches to Community Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03141151
• Other study ID #: 170420
• Status: Completed
• Phase: N/A
• Start date: May 16, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: March 2020
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Childhood
• Pediatric Obesity

Intervention

Behavioral:
• COACH: Healthy Bodies
Staged intensity behavioral intervention focusing on healthy lifestyles in the context of family.
• COACH: Strong Minds
School Readiness Intervention focusing on literacy and parent skills

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Heerman WJ, Teeters L, Sommer EC, Burgess LE, Escarfuller J, Van Wyk C, Barkin SL, Duhon AA, Cole J, Samuels LR, Singer-Gabella M. Competency-Based Approaches to Community Health: A Randomized Controlled Trial to Reduce Childhood Obesity among Latino Pres — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Child Body Mass Index	child BMI trajectory across 12 months; BMI differences over time are estimates from the longitudinal mixed-effects regression model	Baseline, 4 months, 7 months, 1 year
Secondary	Child Diet: Soda	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.)	4 months
Secondary	Child Physical Activity	Parent-reported survey data	4 months
Secondary	Parent BMI		4 months
Secondary	Parent Diet Practices	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.	4 months
Secondary	Parenting Practices: Engagement	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.	4 months