Viewing Study NCT00061165



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Study NCT ID: NCT00061165
Status: COMPLETED
Last Update Posted: 2010-01-13
First Post: 2003-05-21

Brief Title: Obesity Prevention in African American School Children
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization: National Institute of Diabetes and Digestive and Kidney Diseases NIDDK

Study Overview

Official Title: None
Status: COMPLETED
Status Verified Date: 2010-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: None

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: