Program to Prevent Osteoporosis in Girls
Primary Purpose
Osteoporosis
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Increased calcium intake
Weight-bearing physical activity
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis focused on measuring Bone health, Weight-bearing physical activity, Calcium
Eligibility 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
Sites / Locations
- Division of Epidemiology, School of Public Health, University of Minnesota
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00063024
First Posted
June 19, 2003
Last Updated
June 23, 2005
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT00063024
Brief Title
Program to Prevent Osteoporosis in Girls
Official Title
Behavioral Strategies to Prevent Osteoporosis in Girls
Study Type
Interventional
2. Study Status
Record Verification Date
May 2003
Overall Recruitment Status
Unknown status
Study Start Date
June 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Bone health, Weight-bearing physical activity, Calcium
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
322 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Increased calcium intake
Intervention Type
Behavioral
Intervention Name(s)
Weight-bearing physical activity
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simone A. French, Ph.D.
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Epidemiology, School of Public Health, University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454-1015
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Program to Prevent Osteoporosis in Girls
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