NCT02197390

Brief Summary

Our Choice is one of three CORD (Childhood Obesity Research Demonstration) studies funded by the Centers for Disease Control and Prevention in 2011 to test multi-sector, multi-level approaches to prevent and control childhood obesity. Our Choice is translating evidence-based approaches for modifying behaviors, policies, systems, and environments to promote fruit and vegetable consumption, physical activity, water consumption, and quality sleep. The ultimate goal is to assist Children's Health Insurance Program-eligible children between 2-12 years old attain a healthy weight. In addition to site-specific intervention and evaluation activities, Our Choice is working with the University of Houston Evaluation Center to conduct a cross-site evaluation on a set of shared measures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 22, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

3.8 years

First QC Date

July 11, 2014

Last Update Submit

July 15, 2025

Conditions

Childhood Obesity

Keywords

Childhood obesityLatinoHispanic

Outcome Measures

Primary Outcomes (1)

  • BMI z-score change in 1184 children, 2-11 years old, assigned to a Health Care plus Public Health intervention, a Health Care intervention only, a Public Health intervention only, or a control condition

    12-month and 18-month post baseline evaluation; December 2015

Secondary Outcomes (4)

  • Child waist circumference

    12-month and 18-month post baseline evaluation; December 2015

  • Parent waist circumference

    12-month and 18-month post baseline evaluation; December 2015

  • Parent body mass index

    12-month and 18-month post baseline evaluation; December 2015

  • Parent blood pressure

    12-month and 18-month post baseline evaluation; December 2015

Other Outcomes (4)

  • Health clinic health policy adoption

    12-month and 24-month post baseline sector evaluation; October 2015

  • Health clinic implementation of the assessment and treatment of child overweight and obesity guidelines at a specific percentile

    12-month and 24-month post baseline evaluation; October 2015

  • Body mass index in early care and education centers

    Year 1 and Year 2 of intervention; July 2014

  • +1 more other outcomes

Study Arms (4)

Health Care plus Public Health

EXPERIMENTAL

The Health Care intervention involves the implementation of an obesity care model within a Federally Qualified Health Center (FQHC) and includes a Family Wellness Program delivered by Community Health Workers (CHWs). The Public Health intervention involves working with early care and education centers, schools, community recreation organizations, and restaurants to promote four health behaviors: fruit and vegetable consumption, physical activity, water consumption, and quality sleep.

Behavioral: Family wellness workshopsBehavioral: Obesity chronic care modelBehavioral: Physical activity, healthy eating, water drinking, healthy sleep promotionBehavioral: Environment, policy, systems changes in clinic setting onlyBehavioral: Environment, policy, and systems changes in schools, early child care education & recreation

Health Care

EXPERIMENTAL

The Health Care intervention involves the implementation of an obesity care model within a Federally Qualified Health Center (FQHC) and includes a Family Wellness Program delivered by Community Health Workers (CHWs).

Behavioral: Family wellness workshopsBehavioral: Obesity chronic care modelBehavioral: Physical activity, healthy eating, water drinking, healthy sleep promotionBehavioral: Environment, policy, systems changes in clinic setting only

Public Health

EXPERIMENTAL

The Public Health intervention involves working with early care and education centers, schools, community recreation organizations, and restaurants to promote four health behaviors: fruit and vegetable consumption, physical activity, water consumption, and quality sleep.

Behavioral: Physical activity, healthy eating, water drinking, healthy sleep promotionBehavioral: Environment, policy, systems changes in clinic setting only

Control

EXPERIMENTAL

No intervention.

Behavioral: No intervention

Interventions

Family wellness workshopsBEHAVIORAL

Nine family wellness workshops and eight family physical activity sessions facilitated by community health workers.

Health CareHealth Care plus Public Health
Obesity chronic care modelBEHAVIORAL
Health CareHealth Care plus Public Health
Physical activity, healthy eating, water drinking, healthy sleep promotionBEHAVIORAL
Health CareHealth Care plus Public HealthPublic Health
Environment, policy, systems changes in clinic setting onlyBEHAVIORAL
Health CareHealth Care plus Public HealthPublic Health
No interventionBEHAVIORAL

No intervention.

Control
Environment, policy, and systems changes in schools, early child care education & recreationBEHAVIORAL
Health Care plus Public Health

Eligibility Criteria

Age2 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • If family had school-age child, child must attend one of the designated Our Choice schools located in one of three designated cities.
  • If family had preschool-age child, family must reside in one of three designated cities.
  • Children ages 2-11 years old
  • Maximum two children per household
  • Children above the 5th percentile body mass index
  • Family agrees to remain in the area throughout the duration of the study
  • Participating parent had to understand English or Spanish

You may not qualify if:

  • Child has any condition that significantly limits eating or physical activity in a way that interventions would be impacted

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Our Choice

El Centro, California, 92243, United States

Location

San Diego State University Research Foundation

San Diego, California, 92123, United States

Location

Related Publications (4)

  • Chuang E, Ayala GX, Schmied E, Ganter C, Gittelsohn J, Davison KK. Evaluation protocol to assess an integrated framework for the implementation of the Childhood Obesity Research Demonstration project at the California (CA-CORD) and Massachusetts (MA-CORD) sites. Child Obes. 2015 Feb;11(1):48-57. doi: 10.1089/chi.2014.0049. Epub 2014 Nov 25.

    PMID: 25423618BACKGROUND

  • Ayala GX, Ibarra L, Binggeli-Vallarta A, Moody J, McKenzie TL, Angulo J, Hoyt H, Chuang E, Ganiats TG, Gahagan S, Ji M, Zive M, Schmied E, Arredondo EM, Elder JP. Our Choice/Nuestra Opcion: the Imperial County, California, Childhood Obesity Research Demonstration study (CA-CORD). Child Obes. 2015 Feb;11(1):37-47. doi: 10.1089/chi.2014.0080. Epub 2015 Jan 13.

    PMID: 25584664BACKGROUND

  • Chuang E, Brunner J, Moody J, Ibarra L, Hoyt H, McKenzie TL, Binggeli-Vallarta A, Cervantes G, Finlayson TL, Ayala GX. Factors Affecting Implementation of the California Childhood Obesity Research Demonstration (CA-CORD) Project, 2013. Prev Chronic Dis. 2016 Oct 20;13:E147. doi: 10.5888/pcd13.160238.

    PMID: 27763831BACKGROUND

  • Schmied EA, Madanat H, Chuang E, Moody J, Ibarra L, Cervantes G, Strong D, Boutelle K, Ayala GX. Factors predicting parent engagement in a family-based childhood obesity prevention and control program. BMC Public Health. 2023 Mar 8;23(1):457. doi: 10.1186/s12889-023-15359-7.

    PMID: 36890461DERIVED

Related Links

MeSH Terms

Conditions

Pediatric Obesity

Interventions

ExerciseDiet, HealthyWaterEnvironmentPolicySchools

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsEcological and Environmental PhenomenaBiological PhenomenaEnvironment and Public HealthHealth Care Economics and OrganizationsNon-Medical Public and Private Facilities

Study Officials

  • Guadalupe X Ayala, PhD, MPH

    San Diego State University

    PRINCIPAL INVESTIGATOR

  • Leticia Ibarra, MPH

    Clinicas de Salud del Pueblo, Inc.

    STUDY DIRECTOR

  • Amy Binggeli-Vallarta, DrPH, RD

    Imperial County Public Health Department

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2014

First Posted

July 22, 2014

Study Start

May 1, 2012

Primary Completion

February 1, 2016

Study Completion

September 1, 2021

Last Updated

July 18, 2025

Record last verified: 2025-07

Locations

US(2)