Childhood ObesityOur ChoiceNCT02197390
An Ecological Approach to Addressing Childhood Obesity Issues in Imperial County
A study testing Family wellness workshops, Obesity chronic care model and Physical activity, healthy eating, water drinking, healthy sleep promotion in people with Childhood Obesity, run by San Diego State University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Family wellness workshops, Obesity chronic care model and Physical activity, healthy eating, water drinking, healthy sleep promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,184 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2012to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Child has any condition that significantly limits eating or physical activity in a way that interventions would be impacted
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Our Choice
El Centro, California, 92243
San Diego State University Research Foundation
San Diego, California, 92123
About this study
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.
Read the 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.
- Conditions
- Childhood Obesity
- Being tested
- Family wellness workshops, Obesity chronic care model, Physical activity, healthy eating, water drinking, healthy sleep promotion, Environment, policy, systems changes in clinic setting only, No intervention
- Keywords
- Childhood obesity, Latino, Hispanic
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family wellness workshopsBehavioural
Nine family wellness workshops and eight family physical activity sessions facilitated by community health workers.
Obesity chronic care modelBehavioural
Physical activity, healthy eating, water drinking, healthy sleep promotionBehavioural
Environment, policy, systems changes in clinic setting onlyBehavioural
No interventionBehavioural
No intervention.
Environment, policy, and systems changes in schools, early child care education & recreationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
| 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). Receives: 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 |
| 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. Receives: Behavioral: Physical activity, healthy eating, water drinking, healthy sleep promotion; Behavioral: Environment, policy, systems changes in clinic setting only |
| Control | Experimental | No intervention. Receives: Behavioral: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12-month and 18-month post baseline evaluation; December 2015
Secondary outcomes (4)
Child waist circumference
Measured: 12-month and 18-month post baseline evaluation; December 2015
Parent waist circumference
Measured: 12-month and 18-month post baseline evaluation; December 2015
Parent body mass index
Weight and height
Measured: 12-month and 18-month post baseline evaluation; December 2015
Parent blood pressure
Measured: 12-month and 18-month post baseline evaluation; December 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startMay 2012
- Primary completionFeb 2016
- Study completionSep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,184 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Guadalupe X Ayala, PhD, MPH, Principal investigator, San Diego State UniversityLeticia Ibarra, MPH, Study director, Clinicas de Salud del Pueblo, Inc.Amy Binggeli-Vallarta, DrPH, RD, Study director, Imperial County Public Health Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197390
- Sponsor's protocol ID
- 1U18DP003377-03
- Acronym
- Our Choice
- Status last verified
- Jul 2025
- First submitted
- 11 Jul 2014
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 25423618Ayala 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.
PubMed 25584664Chuang 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.
PubMed 27763831Schmied 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.
PubMed 36890461
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Ecological Approach to Addressing Childhood Obesity Issues in Imperial County
- ClinicalTrials.gov ID
- NCT02197390
- Acronym / sponsor ID
- Our Choice / 1U18DP003377-03
- Conditions
- Childhood Obesity
- Keywords
- Childhood obesity, Latino, Hispanic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,184 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- May 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 22 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Health Care plus Public Health | Experimental | 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 & recreationThe 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. |
| Health Care | Experimental | 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 onlyThe 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). |
| Public Health | Experimental | Behavioral: Physical activity, healthy eating, water drinking, healthy sleep promotion, Behavioral: Environment, policy, systems changes in clinic setting onlyThe 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. |
| Control | Experimental | Behavioral: No interventionNo intervention. |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Child has any condition that significantly limits eating or physical activity in a way that interventions would be impacted
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family wellness workshopsNine family wellness workshops and eight family physical activity sessions facilitated by community health workers. | Behavioural | Health Care, Health Care plus Public Health |
| Obesity chronic care model | Behavioural | Health Care, Health Care plus Public Health |
| Physical activity, healthy eating, water drinking, healthy sleep promotion | Behavioural | Health Care, Health Care plus Public Health, Public Health |
| Environment, policy, systems changes in clinic setting only | Behavioural | Health Care, Health Care plus Public Health, Public Health |
| No interventionNo intervention. | Behavioural | Control |
| Environment, policy, and systems changes in schools, early child care education & recreation | Behavioural | Health Care plus Public Health |
Primary outcome
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
4 secondary outcomes
Child waist circumference
Time frame: 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
Parent body mass index
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Background: PubMed 25423618Chuang 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.
- Background: PubMed 25584664Ayala 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.
- Background: PubMed 27763831Chuang 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.
- Derived from this study: PubMed 36890461Schmied 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guadalupe X Ayala, PhD, MPH principal investigator
San Diego State University
Leticia Ibarra, MPH study director
Clinicas de Salud del Pueblo, Inc.
Amy Binggeli-Vallarta, DrPH, RD study director
Imperial County Public Health Department
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family wellness workshops, Obesity chronic care model and Physical activity, healthy eating, water drinking, healthy sleep promotion in people with Childhood Obesity, run by San Diego State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02197390, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.