Osteoporosis Clinical Trial
Official title:
Lifestyle Changes to Increase Bone Density in Teen Girls
Osteoporosis affects nearly half of all American women over age 50. During the teenage years, girls can increase bone growth to decrease their risk of osteoporosis later in life. This study will test whether girls can change their food intake and physical activity patterns in ways that will increase their bone growth during the mid-teen years.
Osteoporosis-related fractures incur an annual cost in the United States of more than $8
billion. Peak bone mass is achieved in the late teens and early 20s. An important component
of a lifelong osteoporosis prevention strategy is to maximize bone mineral content during
the teen years and establish lifestyle patterns that will help maintain bone mineral content
through menopause. This trial will test the efficacy of a comprehensive lifestyle
intervention to build bone and prevent bone loss among adolescent women 14 to 16 years of
age.
Participants in this study will be randomized to either an intervention group or an
attention control group. The intervention program includes a physical activity component
involving high impact and spinal motion activities and a diet component rich in fruits,
vegetables, and calcium. Participants will take part in group and individual meetings and
activities and receive coaching telephone calls. Participants will be assessed at study
entry and two annual follow-up visits. Primary outcome measures include objective measures
(serum folate and carotenoids urinary sodium, lean body mass, accelerometer measure of
physical activity) and self-reports.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
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