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NCT00065039 · ClinicalTrials.gov registry record · Phase 1
Wise Mind: Environmental Approach for Obesity Prevention
A Phase 1 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 1
- Development phase
- 1,000
- Enrollment target
NCT00065039 is a Phase 1 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 1,000 participants.
The verdict
NCT00065039, a Phase 1 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1,000 participants
- Enrollment target
Study 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
Interventions
- BEHAVIORAL Promotion of a healthy diet and physical activity
- BEHAVIORAL Avoidance of Alcohol, Drugs, and Tobacco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2003-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00065039
The ClinicalTrials.gov registry entry for NCT00065039 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Promotion of a healthy diet and physical activity is the first listed.
NCT00065039 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00065039 about?
NCT00065039 is a clinical study titled "Wise Mind: Environmental Approach for Obesity Prevention". 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 ...
What is the current status of trial NCT00065039?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 1,000 participants. The study started on 2003-04.
What interventions are being tested in trial NCT00065039?
The interventions under investigation include: Promotion of a healthy diet and physical activity (BEHAVIORAL), Avoidance of Alcohol, Drugs, and Tobacco (BEHAVIORAL).
Who is sponsoring clinical trial NCT00065039?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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