NCT00428805

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
980

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2007

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

4.3 years

First QC Date

January 26, 2007

Last Update Submit

March 1, 2024

Conditions

Obesity

Keywords

body compositionphysical activitydietary intakechildren

Outcome Measures

Primary Outcomes (5)

  • Increase physical activity

    2010

  • Increase the intake of fiber

    2010

  • Decrease fat intake

    2010

  • Decrease television and other screen time

    2010

  • Decrease obesity

    2010

Secondary Outcomes (6)

  • Changes in Head Start and community policy in regards to physical activity

    2010

  • Changes in Head Start and community policy in regards to school food service

    2010

  • Changes in Head Start and community policy in regards to school snacks

    2010

  • Changes in Head Start and community policy in regards to availability of healthful options

    2010

  • Examine the role of community leaders in raising awareness of obesity prevention

    2010

  • +1 more secondary outcomes

Study Arms (2)

intervention 1

EXPERIMENTAL

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 curriculumBehavioral: In-service training for Head Start teachers/aidesBehavioral: Training for Head Start food serviceBehavioral: Family intervention componentBehavioral: Food sourceBehavioral: Health care providersBehavioral: CHILE Head Start Intervention

control 2

NO INTERVENTION

measurement only control arm

Interventions

classroom curriculumBEHAVIORAL

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.

intervention 1
In-service training for Head Start teachers/aidesBEHAVIORAL

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.

intervention 1
Training for Head Start food serviceBEHAVIORAL

Food service workers are trained (quarterly) to modify food ordering, food preparation, and food serving to match the aims of the study

intervention 1
Family intervention componentBEHAVIORAL

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.

intervention 1
Food sourceBEHAVIORAL

The grocery store component includes field trips, self labeling, and taste testing of promoted foods.

intervention 1
Health care providersBEHAVIORAL

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.

intervention 1
CHILE Head Start InterventionBEHAVIORAL

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.

intervention 1

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • years of age or more at beginning of intervention for each cohort (2)
  • not enrolled in a participating Head Start
  • informed consent not provided

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 871331, United States

Location

Related Publications (3)

  • Morshed AB, Davis SM, Keane PC, Myers OB, Mishra SI. The Impact of the CHILE Intervention on the Food Served in Head Start Centers in Rural New Mexico. J Sch Health. 2016 Jun;86(6):414-23. doi: 10.1111/josh.12393.

    PMID: 27122141DERIVED

  • Cruz TH, Davis SM, Myers OB, O'Donald ER, Sanders SG, Sheche JN. Effects of an Obesity Prevention Intervention on Physical Activity Among Preschool Children: The CHILE Study. Health Promot Pract. 2016 Sep;17(5):693-701. doi: 10.1177/1524839916629974. Epub 2016 Apr 18.

    PMID: 27091603DERIVED

  • Cruz TH, Davis SM, FitzGerald CA, Canaca GF, Keane PC. Engagement, recruitment, and retention in a trans-community, randomized controlled trial for the prevention of obesity in rural American Indian and Hispanic children. J Prim Prev. 2014 Jun;35(3):135-49. doi: 10.1007/s10935-014-0340-9.

    PMID: 24549525DERIVED

MeSH Terms

Conditions

ObesityMotor Activity

Interventions

Health Personnel

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

  • Sally M Davis, Ph.D.

    University of New Mexico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 26, 2007

First Posted

January 30, 2007

Study Start

March 1, 2006

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

March 5, 2024

Record last verified: 2024-03

Locations

US(1)