Competency-based Approaches to Community Health

NCT ID: NCT03141151

Last Updated: 2020-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-16
• Study Completion Date: 2018-08-31

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.

Conditions

Obesity, Childhood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

COACH: Healthy Bodies

This will be a staged intensity behavioral intervention. The intensive phase will last 15 weeks and consist of weekly, 90 minute, skills-building sessions. The content will focus on diet, physical activity, sleep, media use, and parenting. Behavior change techniques will include goal-setting, self-monitoring, and problem solving. Following the intensive phase, participants will enter a maintenance phase, consisting of monthly phone calls from a health coach for 3 months.

Group Type: EXPERIMENTAL

COACH: Healthy Bodies

Intervention Type: BEHAVIORAL

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

COACH: Strong minds

This will be a school-readiness intervention for the 3-5 year old children involved, which will meet twice a month for 3 months. Group sessions will focus on building social support around literacy skills for parents and children, as well as school advocacy.

Group Type: ACTIVE_COMPARATOR

COACH: Strong Minds

Intervention Type: BEHAVIORAL

School Readiness Intervention focusing on literacy and parent skills

Interventions

COACH: Healthy Bodies

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

Intervention Type: BEHAVIORAL

COACH: Strong Minds

School Readiness Intervention focusing on literacy and parent skills

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Bill Heerman

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William Heerman, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

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 Preschool-Aged Children. Child Obes. 2019 Dec;15(8):519-531. doi: 10.1089/chi.2019.0064. Epub 2019 Aug 5.

Reference Type: RESULT

PMID: 31381365 (View on PubMed)

Adams LE, Sommer EC, Truesdale KP, Barkin SL, Heerman WJ. Validation of a new scoring approach of a child dietary questionnaire for use in early childhood among low-income, Latino populations. BMC Nutr. 2022 Oct 31;8(1):125. doi: 10.1186/s40795-022-00618-4.

Reference Type: DERIVED

PMID: 36316788 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

170420

Identifier Type: -

Identifier Source: org_study_id