Clinical trial NCT00241878: Preschool Based Obesity Prevention Effectiveness Trial
Official title: Preschool Based Obesity Prevention Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Heart Diseases
Obesity
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2005-10-19
Enrollment: 648
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Body height and weight
timeFrame: Sept 2006- May 2009
measure: Healthy Start Knowledge Quiz
timeFrame: Sept 2006- May 2009
measure: 24-hour diet observation and recall
timeFrame: Sept 2006- May 2009
measure: Physical activity
timeFrame: Sept 2006- May 2009
measure: Television viewing (child outcomes, measured immediately after the study and at a 1-year follow-up visit)
timeFrame: Sept 2006- May 2009
measure: Score on short Acculturation Scale (parent outcome, measured immediately after the study and at a 1-year follow-up visit)
timeFrame: Sept 2006- May 2009
measure: Nutrition and exercise knowledge
timeFrame: Sept 2006- May 2009
measure: Self-efficacy for eating and exercise behaviors
timeFrame: Sept 2006- May 2009
measure: Score on Nutrition Attitudes Scale
timeFrame: Sept 2006- May 2009
measure: Support and role modeling for healthy eating (teacher outcomes, measured immediately after the study and at a 1-year follow-up visit)
timeFrame: Sept 2006- May 2009
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Illinois at Chicago
name: Marian Fitzgibbon
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kong A, Buscemi J, Stolley MR, Schiffer LA, Kim Y, Braunschweig CL, Gomez-Perez SL, Blumstein LB, Van Horn L, Dyer AR, Fitzgibbon ML. Hip-Hop to Health Jr. Randomized Effectiveness Trial: 1-Year Follow-up Results. Am J Prev Med. 2016 Feb;50(2):136-44. doi: 10.1016/j.amepre.2015.07.008. Epub 2015 Sep 16.