Program to Prevent Osteoporosis in Girls

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

322 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-06-30

Study Completion Date

2004-05-31

Brief Summary

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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

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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.

Conditions

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Osteoporosis

Keywords

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Bone health Weight-bearing physical activity Calcium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Increased calcium intake

Intervention Type BEHAVIORAL

Weight-bearing physical activity

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

9 Years

Maximum Eligible Age

11 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Simone A. French, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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Division of Epidemiology, School of Public Health, University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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R01HD037743

Identifier Type: NIH

Identifier Source: org_study_id

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