An Ecological Approach to Addressing Childhood Obesity Issues in Imperial County (Our Choice)

July 15, 2025 updated by: San Diego State University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Our Choice is a partnership between a university-affiliated research institute, a federally qualified health center, and a county public health department. We used formative research, advisory committee members' recommendations, and previous research to inform the development of the Our Choice project. Our theory-informed multi-sector, multi-level intervention targets improvements in four health behaviors: fruit, vegetable, and water consumption, physical activity, and sleep. Intervention partners include 1200 families, a federally qualified health center (including three clinics), 26 early care and education centers, two elementary school districts (and 20 elementary schools), three community recreation centers, and three restaurants. Intervention components in all sectors target changes in behaviors, policies, systems, and the social and physical environment. Evaluation activities include assessment of the primary outcome, BMI z-score, at baseline, 12- and 18-months post-baseline, and sector evaluations at baseline, 12, and 24-months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1184

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • El Centro, California, United States, 92243
        • Our Choice
      • San Diego, California, United States, 92123
        • San Diego State University Research Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Health Care plus Public Health
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 workshops
Nine family wellness workshops and eight family physical activity sessions facilitated by community health workers.
Behavioral: Obesity chronic care model
Behavioral: Physical activity, healthy eating, water drinking, healthy sleep promotion
Behavioral: Environment, policy, systems changes in clinic setting only
Behavioral: Environment, policy, and systems changes in schools, early child care education & recreation
Experimental: Health Care
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 workshops
Nine family wellness workshops and eight family physical activity sessions facilitated by community health workers.
Behavioral: Obesity chronic care model
Behavioral: Physical activity, healthy eating, water drinking, healthy sleep promotion
Behavioral: Environment, policy, systems changes in clinic setting only
Experimental: Public Health
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 promotion
Behavioral: Environment, policy, systems changes in clinic setting only
Experimental: Control
No intervention.
Behavioral: No intervention
No intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Time Frame: 12-month and 18-month post baseline evaluation; December 2015
12-month and 18-month post baseline evaluation; December 2015

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Child waist circumference
Time Frame: 12-month and 18-month post baseline evaluation; December 2015
12-month and 18-month post baseline evaluation; December 2015
Parent waist circumference
Time Frame: 12-month and 18-month post baseline evaluation; December 2015
12-month and 18-month post baseline evaluation; December 2015
Parent body mass index
Time Frame: 12-month and 18-month post baseline evaluation; December 2015
Weight and height
12-month and 18-month post baseline evaluation; December 2015
Parent blood pressure
Time Frame: 12-month and 18-month post baseline evaluation; December 2015
12-month and 18-month post baseline evaluation; December 2015

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Health clinic health policy adoption
Time Frame: 12-month and 24-month post baseline sector evaluation; October 2015
Clinic manager interviews
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
Time Frame: 12-month and 24-month post baseline evaluation; October 2015
Electronic health records (EHR), attendance sheets of trainings attended by health clinic staff, chronic care days in place at each clinic, EHR modifications for assessment and treatment of childhood overweight and obesity, health message posters installed, satisfaction with aspects of the intervention
12-month and 24-month post baseline evaluation; October 2015
Body mass index in early care and education centers
Time Frame: Year 1 and Year 2 of intervention; July 2014
Height and weight measures of children in 23 early child care and education centers.
Year 1 and Year 2 of intervention; July 2014
Body mass index in elementary schools
Time Frame: Year 1 and year 2 of intervention
Height and weight measures were collected from Kindergarten, 2nd or 3rd, and 5th grade students from 13 elementary schools.
Year 1 and year 2 of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
San Diego State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centers for Disease Control and Prevention

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guadalupe X Ayala, PhD, MPH, San Diego State University
  • Study Director: Leticia Ibarra, MPH, Clinicas de Salud del Pueblo, Inc.
  • Study Director: Amy Binggeli-Vallarta, DrPH, RD, Imperial County Public Health Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1U18DP003377-03 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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