Clinical trial NCT03141151: Competency-based Approaches to Community Health
Official title: Competency-based Approaches to Community Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 117
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Child Body Mass Index
timeFrame: Baseline, 4 months, 7 months, 1 year
Secondary outcomes:
measure: Child Diet: Soda
timeFrame: 4 months
measure: Child Physical Activity
timeFrame: 4 months
measure: Parent BMI
timeFrame: 4 months
measure: Parent Diet Practices
timeFrame: 4 months
measure: Parenting Practices: Engagement
timeFrame: 4 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: William Heerman, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.