Preschool Based Obesity Prevention Effectiveness Trial
Condition: Cardiovascular Diseases; Heart Diseases; Obesity
MeSH terms: Cardiovascular Diseases; Heart Diseases; Obesity
Study type: Interventional

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.
    

Intervention name(s): Teacher-Delivered Weight Control Intervention; Teacher-Delivered General Health Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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; 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention