- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02197390
An Ecological Approach to Addressing Childhood Obesity Issues in Imperial County (Our Choice)
April 18, 2020 updated by: Guadalupe X. Ayala, 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
Unknown
Conditions
Intervention / Treatment
- Behavioral: Family wellness workshops
- 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
- Behavioral: No intervention
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
Interventional
Enrollment (Actual)
1184
Phase
- 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
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California
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El Centro, California, United States, 92243
- Our Choice
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San Diego, California, United States, 92123
- San Diego State University Research Foundation
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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
Ages Eligible for Study
2 years to 11 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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 |
Intervention / Treatment |
---|---|
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.
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Nine family wellness workshops and eight family physical activity sessions facilitated by community health workers.
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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).
|
Nine family wellness workshops and eight family physical activity sessions facilitated by community health workers.
|
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.
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Experimental: Control
No intervention.
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No intervention.
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What is the study measuring?
Primary Outcome Measures
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
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12-month and 18-month post baseline evaluation; December 2015
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child waist circumference
Time Frame: 12-month and 18-month post baseline evaluation; December 2015
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12-month and 18-month post baseline evaluation; December 2015
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Parent waist circumference
Time Frame: 12-month and 18-month post baseline evaluation; December 2015
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12-month and 18-month post baseline evaluation; December 2015
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Parent body mass index
Time Frame: 12-month and 18-month post baseline evaluation; December 2015
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Weight and height
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12-month and 18-month post baseline evaluation; December 2015
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Parent blood pressure
Time Frame: 12-month and 18-month post baseline evaluation; December 2015
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12-month and 18-month post baseline evaluation; December 2015
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health clinic health policy adoption
Time Frame: 12-month and 24-month post baseline sector evaluation; October 2015
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Clinic manager interviews
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12-month and 24-month post baseline sector evaluation; October 2015
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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
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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
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12-month and 24-month post baseline evaluation; October 2015
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Body mass index in early care and education centers
Time Frame: Year 1 and Year 2 of intervention; July 2014
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Height and weight measures of children in 23 early child care and education centers.
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Year 1 and Year 2 of intervention; July 2014
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Body mass index in elementary schools
Time Frame: Year 1 and year 2 of intervention
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Height and weight measures were collected from Kindergarten, 2nd or 3rd, and 5th grade students from 13 elementary schools.
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Year 1 and year 2 of intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- 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
- 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.
- 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.
- 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.
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
May 1, 2012
Primary Completion (Actual)
February 1, 2016
Study Completion (Anticipated)
September 1, 2020
Study Registration Dates
First Submitted
July 11, 2014
First Submitted That Met QC Criteria
July 18, 2014
First Posted (Estimate)
July 22, 2014
Study Record Updates
Last Update Posted (Actual)
April 21, 2020
Last Update Submitted That Met QC Criteria
April 18, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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