Clinical Trials Directory

Trials / Completed

CompletedNCT00067600

Improving Bone Health in Adolescent Girls: The Youth Osteoporosis and Understanding Total Health (YOUTH) Study

Lifestyle Changes to Increase Bone Density in Teen Girls

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
228 (planned)
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
Sex
Female
Age
14 Years – 16 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALDiet with increased fruits, vegetables, and calcium
BEHAVIORALIncreased high impact activity and resistance training

Timeline

Start date
2000-08-01
Primary completion
2003-09-01
Completion
2003-09-01
First posted
2003-08-26
Last updated
2014-10-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00067600. Inclusion in this directory is not an endorsement.