An Ecological Approach to Addressing Childhood Obesity Issues in Imperial County

Childhood Obesity Clinical Trial

— Our Choice  

Official title:

An Ecological Approach to Addressing Childhood Obesity Issues in Imperial County

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02197390
• Other study ID #: 1U18DP003377-03
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2012
• Est. completion date: September 2020

Study information

• Verified date: April 2020
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1184
• Est. completion date: September 2020
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Family wellness workshops
Nine family wellness workshops and eight family physical activity sessions facilitated by community health workers.
• Obesity chronic care model

• Physical activity, healthy eating, water drinking, healthy sleep promotion

• Environment, policy, systems changes in clinic setting only

• No intervention
No intervention.
• Environment, policy, and systems changes in schools, early child care education & recreation

Locations

Country	Name	City	State
United States	Our Choice	El Centro	California
United States	San Diego State University Research Foundation	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
San Diego State University	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 Opción: 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health clinic health policy adoption	Clinic manager interviews	12-month and 24-month post baseline sector evaluation; October 2015
Other	Health clinic implementation of the assessment and treatment of child overweight and obesity guidelines at a specific percentile	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
Other	Body mass index in early care and education centers	Height and weight measures of children in 23 early child care and education centers.	Year 1 and Year 2 of intervention; July 2014
Other	Body mass index in elementary schools	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
Primary	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	Child waist circumference		12-month and 18-month post baseline evaluation; December 2015
Secondary	Parent waist circumference		12-month and 18-month post baseline evaluation; December 2015
Secondary	Parent body mass index	Weight and height	12-month and 18-month post baseline evaluation; December 2015
Secondary	Parent blood pressure		12-month and 18-month post baseline evaluation; December 2015

External Links

•   Click here for more information about the San Diego State University investigators at the Institute for Behavioral & Community Health.