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Home > "P" Clinical Trials Conditions > Program to Prevent Osteoporosis in Girls  Program to Prevent Osteoporosis in Girls
Program to Prevent Osteoporosis in Girls
For Condition: Osteoporosis
Status: No longer recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: Osteoporosis is a condition defined by decreased bone mass. Osteoporosis generally affects older women and can lead to bone fractures. One way to prevent osteoporosis is to build strong, healthy bones during childhood. This study will evaluate a program designed to improve girls' bones. The program encourages eating foods rich in calcium and participating in physical activity.
Details: Osteoporosis affects more than 25 million people in the United States. The majority of bone fractures in older women are related to osteoporosis. Calcium intake and physical activity are two modifiable behaviors associated with peak bone mass. Interventions targeting these behaviors among youth have tremendous public health potential for preventing osteoporosis. This study will assess the feasibility and effectiveness of a 2-year behavioral program designed to increase calcium intake and physical activity among girls ages 9 to 11. Thirty Girl Scout troops will be recruited for the study. Girls will be randomized either to the eating and exercise behavior change program or to a control group. Program components focus on behavioral skills development, goal setting, and self-monitoring for dietary calcium intake and physical activity. The program also works to increase social support from peers and parents. The program will take place during 10 weeks of both the 5th and 6th grade years. The program also includes supporting programs during winter and summer breaks. Outcome assessments will be conducted at baseline, and at 6, 12, and 24 months. Primary outcomes will include dietary calcium intake, physical activity, and bone mineral density.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Minimum Age/Maximum Age: 9 Years/11 Years
Genders: Female
Protocol Entry Criteria: Inclusion Criteria - Member of a Girl Scout troop with at least eight 5th grade girls - Member of the Greater Minneapolis or St. Croix Valley Girl Scout organization - Only troops with unanimous parental consent will be included in the trial
Total Enrollment: 322
Location and Contact Information:
Overall Study Official:
SimoneFrench, Principal Investigator, University of Minnesota
Division of Epidemiology, School of Public Health, University of Minnesota
Minneapolis, Minnesota, 55454-1015
United States
Additional Information:
Study ID Numbers: R01HD37743;
Study Start Date: June 1999
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00063024
Other Osteoporosis Studies:
1. Phase 2 Study assessing AMG 162 in the treatment of women with low bone density
2. Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis
3. Effect of Androgen Suppression on Bone Loss in Patients With or Without Bone Metastases Secondary to Prostate Cancer
4. Osteoporosis Prevention After Heart Transplant
5. Lead Exposure, Genetics, and Osteoporosis Epidemiology
Related Studies:
Other Osteoporosis Clinical Trials
Other Minnesota Clinical Trials
Other Minneapolis Clinical Trials
Program to Prevent Osteoporosis in Girls
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