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Preschool Based Obesity Prevention Effectiveness Trial

Not Applicable
Completed
Conditions
Heart Diseases
Obesity
Cardiovascular Diseases
Interventions
Behavioral: Teacher-Delivered Weight Control Intervention
Behavioral: Teacher-Delivered General Health Intervention
Registration Number
NCT00241878
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Brief Summary

The purpose of this study is to compare changes in body mass index (BMI) among 3- to 5-year-old minority children randomized to a weight control intervention (WCI) or a general health control intervention.

Detailed Description

BACKGROUND:

Obesity is epidemic in the U.S. and is associated with increased risk for numerous medical problems. Many obesity-related risk factors are strikingly apparent in minority populations. Ethnic differences in obesity related risk factors begin as early as six to nine years of age. Thus, the need for overweight prevention efforts as early as the preschool years is critical.

This study builds upon the findings of the "Hip-Hop to Health" program. The primary aim of Hip-Hop was to compare changes in body mass index (BMI \[kg/m2\]) in two groups of 3- to 5-year-old minority children randomized to a Weight Control Intervention (WCI) or a General Health Control Intervention (GHI). Results for the children at the Year 1 and 2 follow-ups showed that children in the WCI had significantly smaller relative changes in BMI compared to children in the GHI control group. The success was among the schools that served predominantly Black children. Hip-Hop to Health was an efficacy trial delivered by trained specialists in early childhood education, and the first efficacy trial to document change in BMI in preschool children.

DESIGN NARRATIVE:

This study will test a 14-week teacher-delivered weight control intervention (TD-WCI) to a 14-week teacher delivered general health control intervention (TD-GHI) in a randomized community trial occurring in 16 preschools in the Chicago School District. The study has the following aims: 1) to compare children in these two conditions on changes in BMI post intervention and at Year 1 follow-up; 2) to compare children in these two conditions on changes in television viewing, physical activity, and fat, fiber, fruit and vegetable intake at post-intervention and Year 1 follow-up; and 3) to compare classroom teachers in these two conditions on nutrition and exercise knowledge, nutrition attitudes, and support for healthy eating post-intervention and Year 1 follow-up.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
648
Inclusion Criteria
  • Have received an annual physical
  • Parent or guardian willing to give informed consent
  • Parent or guardian willing to provide demographic and anthropometric data and agree to complete food intake and physical activity information for their child
Exclusion Criteria
  • Requires a specialized diet outside of that served by the Chicago Public Schools
  • Has a chronic physical or behavioral disorder that requires participant to be under close medical psychological supervision and routinely absent from the study

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1Teacher-Delivered Weight Control InterventionTeacher-Delivered Weight Control Intervention
2Teacher-Delivered General Health InterventionTeacher-Delivered General Health Intervention
Primary Outcome Measures
NameTimeMethod
Television viewing (child outcomes, measured immediately after the study and at a 1-year follow-up visit)Sept 2006- May 2009
Score on Nutrition Attitudes ScaleSept 2006- May 2009
Score on short Acculturation Scale (parent outcome, measured immediately after the study and at a 1-year follow-up visit)Sept 2006- May 2009
Self-efficacy for eating and exercise behaviorsSept 2006- May 2009
Support and role modeling for healthy eating (teacher outcomes, measured immediately after the study and at a 1-year follow-up visit)Sept 2006- May 2009
Body height and weightSept 2006- May 2009
Healthy Start Knowledge QuizSept 2006- May 2009
24-hour diet observation and recallSept 2006- May 2009
Physical activitySept 2006- May 2009
Nutrition and exercise knowledgeSept 2006- May 2009
Secondary Outcome Measures
NameTimeMethod
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