Preschool Based Obesity Prevention Effectiveness Trial
Recruitment status was Active, not recruiting
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Purpose
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 | Intervention |
|---|---|
|
Cardiovascular Diseases Heart Diseases Obesity |
Behavioral: Teacher-Delivered Weight Control Intervention Behavioral: Teacher-Delivered General Health Intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Preschool Based Obesity Prevention Effectiveness Trial |
- Body height and weight [ Time Frame: Sept 2006- May 2009 ] [ Designated as safety issue: No ]
- Healthy Start Knowledge Quiz [ Time Frame: Sept 2006- May 2009 ] [ Designated as safety issue: No ]
- 24-hour diet observation and recall [ Time Frame: Sept 2006- May 2009 ] [ Designated as safety issue: No ]
- Physical activity [ Time Frame: Sept 2006- May 2009 ] [ Designated as safety issue: No ]
- Television viewing (child outcomes, measured immediately after the study and at a 1-year follow-up visit) [ Time Frame: Sept 2006- May 2009 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Nutrition and exercise knowledge [ Time Frame: Sept 2006- May 2009 ] [ Designated as safety issue: No ]
- Self-efficacy for eating and exercise behaviors [ Time Frame: Sept 2006- May 2009 ] [ Designated as safety issue: No ]
- Score on Nutrition Attitudes Scale [ Time Frame: Sept 2006- May 2009 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 648 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | May 2009 |
| Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 3 Years to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 More Information
No publications provided
| 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, R01 HL81645 |
| Study First Received: | October 17, 2005 |
| Last Updated: | January 18, 2008 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Heart Diseases Obesity Overnutrition |
Nutrition Disorders Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013