Clinical trial NCT00065039: Wise Mind: Environmental Approach for Obesity Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2003-07-18
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: PREVENTION

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 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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References:
citation: Williamson DA, Han H, Johnson WD, Martin CK, Newton RL Jr. Modification of the school cafeteria environment can impact childhood nutrition. Results from the Wise Mind and LA Health studies. Appetite. 2013 Feb;61(1):77-84. doi: 10.1016/j.appet.2012.11.002. Epub 2012 Nov 12.