Program to Prevent Osteoporosis in Girls
|ClinicalTrials.gov Identifier: NCT00063024|
Recruitment Status : Unknown
Verified May 2003 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was: Active, not recruiting
First Posted : June 20, 2003
Last Update Posted : June 24, 2005
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis||Behavioral: Increased calcium intake Behavioral: Weight-bearing physical activity||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||322 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Behavioral Strategies to Prevent Osteoporosis in Girls|
|Study Start Date :||June 1999|
|Estimated Study Completion Date :||May 2004|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00063024
|United States, Minnesota|
|Division of Epidemiology, School of Public Health, University of Minnesota|
|Minneapolis, Minnesota, United States, 55454-1015|
|Principal Investigator:||Simone A. French, Ph.D.||University of Minnesota - Clinical and Translational Science Institute|