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

Primary Purpose

Childhood Obesity

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
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
Environment, policy, and systems changes in schools, early child care education & recreation
Sponsored by
San Diego State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring Childhood obesity, Latino, Hispanic

Eligibility Criteria

2 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Our Choice
  • San Diego State University Research Foundation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Health Care plus Public Health

Health Care

Public Health

Control

Arm Description

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.

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.

No intervention.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Child waist circumference
Parent waist circumference
Parent body mass index
Weight and height
Parent blood pressure

Full Information

First Posted
July 11, 2014
Last Updated
April 18, 2020
Sponsor
San Diego State University
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT02197390
Brief Title
An Ecological Approach to Addressing Childhood Obesity Issues in Imperial County
Acronym
Our Choice
Official Title
An Ecological Approach to Addressing Childhood Obesity Issues in Imperial County
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Diego State University
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Childhood obesity, Latino, Hispanic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health Care plus Public Health
Arm Type
Experimental
Arm Description
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.
Arm Title
Health Care
Arm Type
Experimental
Arm Description
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).
Arm Title
Public Health
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Experimental
Arm Description
No intervention.
Intervention Type
Behavioral
Intervention Name(s)
Family wellness workshops
Intervention Description
Nine family wellness workshops and eight family physical activity sessions facilitated by community health workers.
Intervention Type
Behavioral
Intervention Name(s)
Obesity chronic care model
Intervention Type
Behavioral
Intervention Name(s)
Physical activity, healthy eating, water drinking, healthy sleep promotion
Intervention Type
Behavioral
Intervention Name(s)
Environment, policy, systems changes in clinic setting only
Intervention Type
Behavioral
Intervention Name(s)
No intervention
Intervention Description
No intervention.
Intervention Type
Behavioral
Intervention Name(s)
Environment, policy, and systems changes in schools, early child care education & recreation
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Child waist circumference
Time Frame
12-month and 18-month post baseline evaluation; December 2015
Title
Parent waist circumference
Time Frame
12-month and 18-month post baseline evaluation; December 2015
Title
Parent body mass index
Description
Weight and height
Time Frame
12-month and 18-month post baseline evaluation; December 2015
Title
Parent blood pressure
Time Frame
12-month and 18-month post baseline evaluation; December 2015
Other Pre-specified Outcome Measures:
Title
Health clinic health policy adoption
Description
Clinic manager interviews
Time Frame
12-month and 24-month post baseline sector evaluation; October 2015
Title
Health clinic implementation of the assessment and treatment of child overweight and obesity guidelines at a specific percentile
Description
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
Time Frame
12-month and 24-month post baseline evaluation; October 2015
Title
Body mass index in early care and education centers
Description
Height and weight measures of children in 23 early child care and education centers.
Time Frame
Year 1 and Year 2 of intervention; July 2014
Title
Body mass index in elementary schools
Description
Height and weight measures were collected from Kindergarten, 2nd or 3rd, and 5th grade students from 13 elementary schools.
Time Frame
Year 1 and year 2 of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guadalupe X Ayala, PhD, MPH
Organizational Affiliation
San Diego State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leticia Ibarra, MPH
Organizational Affiliation
Clinicas de Salud del Pueblo, Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Amy Binggeli-Vallarta, DrPH, RD
Organizational Affiliation
Imperial County Public Health Department
Official's Role
Study Director
Facility Information:
Facility Name
Our Choice
City
El Centro
State/Province
California
ZIP/Postal Code
92243
Country
United States
Facility Name
San Diego State University Research Foundation
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25423618
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.
Results Reference
background
PubMed Identifier
25584664
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.
Results Reference
background
PubMed Identifier
27763831
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.
Results Reference
background
Links:
URL
http://www.ibachsd.org
Description
Click here for more information about the San Diego State University investigators at the Institute for Behavioral & Community Health.

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An Ecological Approach to Addressing Childhood Obesity Issues in Imperial County

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