Kaiser Permanente Center for Health Research
Portland, Oregon, 97227, United States
NCT Number: NCT00067600
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.
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Notify Me14 year–16 year
Female
Interventional
Phase 1
Portland, Oregon, 97227, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline, 1 year, and 2 years
Changes in TBBMD as measured by DEXA at baseline, 1 year, and 2 years
Time frame: Baseline, 1 year, and 2 years
Biologic measures of bone metabolism
Time frame: Baseline, 1 year, and 2 years
Biologic measures of dietary change
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Nih
Lifestyle Changes to Increase Bone Density in Teen Girls
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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