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Program to Prevent Osteoporosis in Girls
This study is ongoing, but not recruiting participants.
Study NCT00063024   Information provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First Received: June 19, 2003   Last Updated: June 23, 2005   History of Changes

June 19, 2003
June 23, 2005
June 1999
 
 
 
Complete list of historical versions of study NCT00063024 on ClinicalTrials.gov Archive Site
 
 
 
Program to Prevent Osteoporosis in Girls
Behavioral Strategies to Prevent Osteoporosis in Girls

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.

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.

Phase III
Interventional
Prevention, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Osteoporosis
  • Behavioral: Increased calcium intake
  • Behavioral: Weight-bearing physical activity
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
322
May 2004
 

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
Female
9 Years to 11 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00063024
 
R01HD37743
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 
Principal Investigator: Simone A. French, Ph.D. University of Minnesota
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
May 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP