Competency-based Approaches to Community Health

NCT03141151 | Completed Results DMC

• 1 other identifier: 170420
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Child Diet: Soda

  4 months

• Child Physical Activity

  4 months

• Parent BMI

  4 months

• Parent Diet Practices

  4 months

• Parenting Practices: Engagement

  4 months

Study Arms (2)

COACH: Healthy Bodies

EXPERIMENTAL

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.

Behavioral: COACH: Healthy Bodies

COACH: Strong minds

ACTIVE COMPARATOR

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.

Behavioral: COACH: Strong Minds

Interventions

COACH: Healthy Bodies BEHAVIORAL

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

COACH: Healthy Bodies

COACH: Strong Minds BEHAVIORAL

School Readiness Intervention focusing on literacy and parent skills

COACH: Strong minds

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (2)

• 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.

  PMID: 31381365 RESULT

• 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.

  PMID: 36316788 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study was conducted among Latino families; findings should not be generalized to other populations.

Results Point of Contact

• Title: William Heerman, MD MPH
• Organization: Vanderbilt University Medical Center

bill.heerman@vumc.org

615-322-7080

Study Officials

• William Heerman, MD MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators and data collectors will be blinded to randomization status. Because this is a behavioral intervention, the participants and interventionists will be unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 4, 2017
• Study Start: May 16, 2017
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: March 20, 2020
• Results First Posted: March 20, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)