Preschool Based Obesity Prevention Effectiveness Trial
2 other identifiers
interventional
648
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cardiovascular-diseases
Started Sep 2006
Typical duration for not_applicable cardiovascular-diseases
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2005
CompletedFirst Posted
Study publicly available on registry
October 19, 2005
CompletedStudy Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedMay 5, 2016
December 1, 2007
2.7 years
October 17, 2005
May 4, 2016
Conditions
Outcome Measures
Primary Outcomes (10)
Body height and weight
Sept 2006- May 2009
Healthy Start Knowledge Quiz
Sept 2006- May 2009
24-hour diet observation and recall
Sept 2006- May 2009
Physical activity
Sept 2006- May 2009
Television viewing (child outcomes, measured immediately after the study and at a 1-year follow-up visit)
Sept 2006- May 2009
Score on short Acculturation Scale (parent outcome, measured immediately after the study and at a 1-year follow-up visit)
Sept 2006- May 2009
Nutrition and exercise knowledge
Sept 2006- May 2009
Self-efficacy for eating and exercise behaviors
Sept 2006- May 2009
Score on Nutrition Attitudes Scale
Sept 2006- May 2009
Support and role modeling for healthy eating (teacher outcomes, measured immediately after the study and at a 1-year follow-up visit)
Sept 2006- May 2009
Study Arms (2)
1
EXPERIMENTALTeacher-Delivered Weight Control Intervention
2
OTHERTeacher-Delivered General Health Intervention
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 26385162DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marian Fitzgibbon
University of Illinois at Chicago
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
October 17, 2005
First Posted
October 19, 2005
Study Start
September 1, 2006
Primary Completion
May 1, 2009
Study Completion
May 1, 2010
Last Updated
May 5, 2016
Record last verified: 2007-12