Clinical trial NCT02197390: An Ecological Approach to Addressing Childhood Obesity Issues in Imperial County
Official title: An Ecological Approach to Addressing Childhood Obesity Issues in Imperial County
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Childhood Obesity
Keywords: Childhood obesity
Latino
Hispanic
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2014-07-22
Enrollment: 1184
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: 12-month and 18-month post baseline evaluation; December 2015
Secondary outcomes:
measure: Child waist circumference
timeFrame: 12-month and 18-month post baseline evaluation; December 2015
measure: Parent waist circumference
timeFrame: 12-month and 18-month post baseline evaluation; December 2015
measure: Parent body mass index
timeFrame: 12-month and 18-month post baseline evaluation; December 2015
measure: Parent blood pressure
timeFrame: 12-month and 18-month post baseline evaluation; December 2015
Other outcomes:
measure: Health clinic health policy adoption
timeFrame: 12-month and 24-month post baseline sector evaluation; October 2015
measure: Health clinic implementation of the assessment and treatment of child overweight and obesity guidelines at a specific percentile
timeFrame: 12-month and 24-month post baseline evaluation; October 2015
measure: Body mass index in early care and education centers
timeFrame: Year 1 and Year 2 of intervention; July 2014
measure: Body mass index in elementary schools
timeFrame: Year 1 and year 2 of intervention
Locations:
city: El Centro
country: United States
facility: Our Choice
state: California
city: San Diego
country: United States
facility: San Diego State University Research Foundation
state: California
Study officials:
affiliation: San Diego State University
name: Guadalupe X Ayala, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinicas de Salud del Pueblo, Inc.
name: Leticia Ibarra, MPH
role: STUDY_DIRECTOR
affiliation: Imperial County Public Health Department
name: Amy Binggeli-Vallarta, DrPH, RD
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.