Wise Mind: Environmental Approach for Obesity Prevention

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00065039
First received: July 16, 2003
Last updated: January 12, 2010
Last verified: January 2010
  Purpose

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 1,000 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, i.e., 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.


Condition Intervention Phase
Healthy
Behavioral: Promotion of a healthy diet and physical activity
Behavioral: Avoidance of Alcohol, Drugs, and Tobacco
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment: 1000
Study Start Date: April 2003
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • Must be a student in one of the four catholic schools in Baton Rouge that have elected to participate in the study.
  • Must be in the second through sixth grade at the start of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00065039

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
  More Information

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00065039     History of Changes
Other Study ID Numbers: YSMIND (completed)
Study First Received: July 16, 2003
Last Updated: January 12, 2010
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on August 01, 2014