Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00065039
Status:
COMPLETED
Last Update Posted:
2010-01-13
First Post:
2003-07-16
Brief Title:
Wise Mind Environmental Approach for Obesity Prevention
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:
The study will be conducted in four Catholic schools with children enrolled in Grades 2 through 6 Girls and boys and children of all racial types are eligible for participation in the study We anticipate that approximately 1000 to 1200 children will volunteer for the study We request enrollment of 1200 children To participate parents must grant written consent and the child must assent by signing a consent form that is attached Two of the four schools that volunteer for participation in the study and are approved by the research team will be randomly assigned to a health promotion program called Wise Mind for Diet and Physical Activity The other two schools will be randomly assigned to a program called Wise Mind for Avoidance of Alcohol Drugs and Tobacco Students will receive the program in the school that they attend They will not be allowed to select one of the programs and will receive only one program ie the program in their school Both health promotion programs will last for two academic years Each year every child that is a research participant will be tested on two occasions once during the first two months of school Sept and Oct and once during the last two months of school March and April Testing will not be conducted during May in order to avoid interference with school activities at the end of the academic year All children in all four schools will have the same testing The testing will involve confidential measurement of eating habits food intake physical activity habits attitudes about alcohol drugs and tobacco body weight and height body fatness body image mood and self-esteem The measurement techniques that will be used for this measurement will include questionnaires weighing measurement of height and photography of foods before and after eating All measurements will be confidential and will not be released to anyone that is not involved in the management of the study including school personnel The total time requirement for each testing period is expected to be approximately three hours spread over four testing periods during a two-week period The testing periods will be conducted in conjunction with school administrators and will not be scheduled to conflict with important school activities classes or academic tests A Data and Safety Monitoring Board DSMB will be organized to provide oversight for the conduct of the study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None