- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00061165
Obesity Prevention in African American School Children
January 12, 2010 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Obesity is the second leading preventable cause of disease and death in the United States.
Low socioeconomic status (SES) and minorities are disproportionately affected.
Obesity prevention among children and adolescents is a public health priority.
Schools have been identified as key settings for obesity prevention; however, most health education interventions have had only a moderate effect on body weight.
We propose a randomized intervention trial (pilot study) to test the feasibility and effectiveness of a school-based, environmental obesity prevention program in urban low-SES African American students.
Schools, students and their families, and local communities will be involved to promote healthy eating and physical activity (HEPA) for prevention of childhood obesity.
Six Chicago public schools will be randomly assigned as intervention (4 schools) and controls (2 schools).
Focus group studies will assess needs and barriers for promotion of HEPA and guide the intervention.
The intervention group will receive a School Environment Enrichment (SEE) program to modify the school physical and social environment, targeting food service, recess, physical education (PE) and school climate, and a Community Support & Environment Modification (CSEM) program, involving local corner and chain grocery stores to promote healthy eating among students and their families.
Family involvement will be included for 5th and 6th graders, who will be followed for two years, to test ways to modify family environment.
To assess the intervention effectiveness, multilevel data will be collected from schools (eg, food service, recess and PE), students (eg, body weight, eating and physical activity), parents (eg, family food purchasing practices) and communities (eg, available choices of snack foods in local stores).
In addition, process evaluation data will be collected to assess the feasibility and acceptance (participation and satisfaction) of various intervention components by the target audience.
The primary outcome variable is change in students' body weight status; secondary outcomes include changes in students' eating behavior and physical activity and changes in target environmental factors.
In addition, cost-effectiveness of the intervention will be determined.
If the intervention proves effective, a full-scale study will be developed.
Findings from this study will provide insights into the prevention of obesity among low-SES and minority students.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
900
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Chicago, Illinois, United States, 60612
- University of Illinois at Chicago, Department of Human Nutrition
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
All 4-6th graders in the selected public schools in Chicago and their parents/guardians
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Youfa Wang, PhD, MD, University of Illinois at Chicago, Department of Human Nutrition
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2003
Study Registration Dates
First Submitted
May 21, 2003
First Submitted That Met QC Criteria
May 22, 2003
First Posted (Estimate)
May 23, 2003
Study Record Updates
Last Update Posted (Estimate)
January 13, 2010
Last Update Submitted That Met QC Criteria
January 12, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPAASC (completed)
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