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Preschool Based Obesity Prevention Effectiveness Trial

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ClinicalTrials.gov Identifier: NCT00241878
Recruitment Status : Completed
First Posted : October 19, 2005
Last Update Posted : May 5, 2016
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Cardiovascular Diseases Heart Diseases Obesity Behavioral: Teacher-Delivered Weight Control Intervention Behavioral: Teacher-Delivered General Health 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 648 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preschool Based Obesity Prevention Effectiveness Trial
Study Start Date : September 2006
Primary Completion Date : May 2009
Study Completion Date : May 2010
Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Teacher-Delivered Weight Control Intervention
Behavioral: Teacher-Delivered Weight Control Intervention
The teacher-delivered weight control intervention (TD-WCI) is implemented over 14 weeks with three lessons per week. Many lessons include the use of colorful, friendly, hand-made puppets that represent the seven food groups of the food pyramid (Miss Grain, Miss Fruit, Mr. Vegetable, Mr. Protein, Miss Dairy, Mr. Fat and Miss Sugar). Please see Appendix IX for complete curriculum and pictures of puppets. There are three 40-minute lessons per week that consist of a 15-20 minutes interactive healthy eating and exercise didactic session and then 20 minutes of ongoing physical activity (5 minutes warm-up, 15 minutes aerobic activity composed of a number of games and dances with music, 5 minutes cool-down). In addition to the child-based curriculum the WCI has parent newsletters. These newsletters are distributed on a weekly basis and provide information that parallels the children's curriculum
2
Teacher-Delivered General Health Intervention
Behavioral: Teacher-Delivered General Health Intervention
The teacher-delivered general health intervention (TD-GHI) serves as the control group in the proposed study. TD-GHI is a general health intervention that is similar in structure and length to TD-WCI. Topics include those related to general health and safety, such as car safety, being a good friend, poison safety, disease prevention, etc. An example of an activity is the 911 emergency call. The children learn what 911 is and what would be an appropriate call. They then practice calling 911 on play telephones and relating the important information: nature of the emergency, their name, their address, etc. They learn also to stay on the phone with the 911 dispatcher until someone comes to help them. In addition to the child-based curriculum the GHI has parent newsletters. Like TD-WCI these newsletters are distributed on a weekly basis and provide information that parallels the children's curriculum


Outcome Measures

Primary Outcome Measures :
  1. Body height and weight [ Time Frame: Sept 2006- May 2009 ]
  2. Healthy Start Knowledge Quiz [ Time Frame: Sept 2006- May 2009 ]
  3. 24-hour diet observation and recall [ Time Frame: Sept 2006- May 2009 ]
  4. Physical activity [ Time Frame: Sept 2006- May 2009 ]
  5. Television viewing (child outcomes, measured immediately after the study and at a 1-year follow-up visit) [ Time Frame: Sept 2006- May 2009 ]
  6. Score on short Acculturation Scale (parent outcome, measured immediately after the study and at a 1-year follow-up visit) [ Time Frame: Sept 2006- May 2009 ]
  7. Nutrition and exercise knowledge [ Time Frame: Sept 2006- May 2009 ]
  8. Self-efficacy for eating and exercise behaviors [ Time Frame: Sept 2006- May 2009 ]
  9. Score on Nutrition Attitudes Scale [ Time Frame: Sept 2006- May 2009 ]
  10. Support and role modeling for healthy eating (teacher outcomes, measured immediately after the study and at a 1-year follow-up visit) [ Time Frame: Sept 2006- May 2009 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00241878


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Marian Fitzgibbon University of Illinois at Chicago
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eric Gislason, Office of Research Services, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT00241878     History of Changes
Other Study ID Numbers: 334
R01HL081645 ( U.S. NIH Grant/Contract )
First Posted: October 19, 2005    Key Record Dates
Last Update Posted: May 5, 2016
Last Verified: December 2007

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