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Preschool Based Obesity Prevention Effectiveness Trial

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status

Completed

Conditions

Obesity
Cardiovascular Diseases
Heart Diseases

Treatments

Behavioral: Teacher-Delivered Weight Control Intervention
Behavioral: Teacher-Delivered General Health Intervention

Study type

Interventional

Funder types

NIH

Identifiers

NCT00241878
R01HL081645 (U.S. NIH Grant/Contract)
334

Details and patient eligibility

About

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.

Full 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.

Enrollment

648 estimated patients

Sex

All

Ages

3 to 5 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

648 participants in 2 patient groups

1
Experimental group
Description:
Teacher-Delivered Weight Control Intervention
Treatment:
Behavioral: Teacher-Delivered Weight Control Intervention
2
Other group
Description:
Teacher-Delivered General Health Intervention
Treatment:
Behavioral: Teacher-Delivered General Health Intervention

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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