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.

Study Overview

• Status: Unknown
• Conditions: Osteoporosis
• Intervention / Treatment: Behavioral: Increased calcium intake; Behavioral: Weight-bearing 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.

• Study Type: Interventional
• Enrollment: 322
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454-1015
      • Division of Epidemiology, School of Public Health, University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 11 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Simone A. French, Ph.D., University of Minnesota

Study record dates

Study Major Dates

• Study Start: June 1, 1999
• Study Completion: May 1, 2004

Study Registration Dates

• First Submitted: June 19, 2003
• First Submitted That Met QC Criteria: June 19, 2003
• First Posted (Estimate): June 20, 2003

Study Record Updates

• Last Update Posted (Estimate): June 24, 2005
• Last Update Submitted That Met QC Criteria: June 23, 2005
• Last Verified: May 1, 2003

More Information

Terms related to this study

• Keywords: Calcium; Bone health; Weight-bearing physical activity
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: R01HD037743 (U.S. NIH Grant/Contract)