Child Health Initiative for Lifelong Eating and Exercise (CHILE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by University of New Mexico.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00428805
First received: January 26, 2007
Last updated: January 11, 2010
Last verified: July 2009
  Purpose

Child Health Initiative for Lifelong Eating and Exercise (CHILE) is a trans-community multidisciplinary site-specific intervention and evaluation plan for a Head Start and family-based culturally and developmentally appropriate intervention. The primary goals are to increase physical activity and improve dietary intake through increased consumption of fruits, vegetables and whole grain and decrease consumption of sweetened drinks and high-fat foods,decrease television and other screen time, and decrease obesity in three to five year old Hispanic and American Indian children enrolled in Head Start programs in rural New Mexico. The trans-community intervention includes: A classroom curriculum for children; an in-service training program for Head Start teachers and educational aides; a school food service component; a family intervention; a community leader/local health care provider component; and a grocery store component.

Participants include 16 Head Start programs serving Hispanic and Native American children and families from underserved communities in rural New Mexico. This is a randomized trial with an Intervention Condition and Control Condition. One cohort of three-year old Head Start students will be followed and measured for two years. During the two years in Head Start those children, their teachers, and families enrolled in the Intervention Condition will receive a program of activities to modify their dietary, physical activity, and screen viewing behaviors. Also addressed are the Head Start and community environments and policies, local grocery stores, and health care providers.

CHILE uses an ecological framework including social cognitive theory, intervention mapping, environmental and policy changes, developmental theory, and sound educational practices. The approach includes in from the community to ensure acceptability, cultural appropriateness, feasibility, sustainability, and later transferability to similar communities.

The primary outcome measures include changes in physical activity levels, dietary fiber intake, dietary fat intake, intake of sugared drinks, television viewing and other screen time, in BMI. Secondary measures include changes in the Head Start and community environments and policies related to physical activity, school food service, school snacks, and availability of healthful options. We will also examine the role of community leaders, especially health care providers, in raising awareness and creating a supportive and sustainable environment for the prevention of obesity.


Condition Intervention
Obesity
Behavioral: classroom curriculum
Behavioral: In-service training for Head Start teachers/aides
Behavioral: Training for Head Start food service
Behavioral: Family intervention component
Behavioral: Food source
Behavioral: Health care providers
Behavioral: CHILE Head Start Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Site Specific Approaches to Prevention or Management of Pediatric Obesity: Child Health Initiative for Lifelong Eating and Exercise--CHILE

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • Increase physical activity [ Time Frame: 2010 ] [ Designated as safety issue: No ]
  • Increase the intake of fiber [ Time Frame: 2010 ] [ Designated as safety issue: No ]
  • Decrease fat intake [ Time Frame: 2010 ] [ Designated as safety issue: No ]
  • Decrease television and other screen time [ Time Frame: 2010 ] [ Designated as safety issue: No ]
  • Decrease obesity [ Time Frame: 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in Head Start and community policy in regards to physical activity [ Time Frame: 2010 ] [ Designated as safety issue: No ]
  • Changes in Head Start and community policy in regards to school food service [ Time Frame: 2010 ] [ Designated as safety issue: No ]
  • Changes in Head Start and community policy in regards to school snacks [ Time Frame: 2010 ] [ Designated as safety issue: No ]
  • Changes in Head Start and community policy in regards to availability of healthful options [ Time Frame: 2010 ] [ Designated as safety issue: No ]
  • Examine the role of community leaders in raising awareness of obesity prevention [ Time Frame: 2010 ] [ Designated as safety issue: No ]
  • Examine the role of community leaders in creating a supportive environment for the prevention of obesity [ Time Frame: 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 640
Study Start Date: March 2006
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intervention 1
This transcommunity study has one intervention and one control group. The intervention, described elsewhere has 6 components--classroom curriculum, family component,grocery store component, health care provider component, training for Head Start food service workers,and training for Head Start teachers/aides.
Behavioral: classroom curriculum

classroom curriculum for 3 & 4 year old children includes activities to increase intake of fruits, vegetables, & whole grains; increase physical activity; decrease intake of fats and sugared drinks; and decrease screen time following monthly learning modules.

Teachers are trained to carry out the classroom curriculum.

Behavioral: In-service training for Head Start teachers/aides
Teachers and teacher aides are trained quarterly by certified trainers and receive a certificate for participating in the training. Topics include the content as well as developmental concepts.
Behavioral: Training for Head Start food service
Food service workers are trained (quarterly) to modify food ordering, food preparation, and food serving to match the aims of the study
Behavioral: Family intervention component
Families receive the CHILE intervention quarterly at Family Events. These include family activities to increase intake of fruits, vegetables, whole grains, decrease intake of fats and sugared drinks, increase of physical activity and decrease screen time. Parenting skills are also included.
Behavioral: Food source
The grocery store component includes field trips, self labeling, and taste testing of promoted foods.
Behavioral: Health care providers
The health care provider component includes the health care providers presenting at the Family Events and reinforcing the CHILE intervention message in the practice setting when talking with families of head start children.
Behavioral: CHILE Head Start Intervention
There are six components of this transcommunity social-ecological intervention including a classroom curriculum, health care provider component, family component, training of Head Start teachers/aides, training of food service staff and grocery store component.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 3 years of age of beginning of intervention for each cohort (2)
  • enrolled in participating Head Start
  • informed consent signed by parent or legal guardian

Exclusion Criteria:

  • 4 years of age or more at beginning of intervention for each cohort (2)
  • not enrolled in a participating Head Start
  • informed consent not provided
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00428805

Contacts
Contact: Sally M Davis, Ph.D. 505 272-4462

Locations
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 871331
Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Sally M Davis, Ph.D. University of New Mexico
  More Information

No publications provided

Responsible Party: Sally M. Davis, University of New Mexico Prevention Research Center
ClinicalTrials.gov Identifier: NCT00428805     History of Changes
Other Study ID Numbers: DK72958, R01DK072958
Study First Received: January 26, 2007
Last Updated: January 11, 2010
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of New Mexico:
body composition
physical activity
dietary intake
children

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 14, 2014