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

Phase 1

Completed

• Conditions: Osteoporosis

• Registration Number: NCT00067600
• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief 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.

Study Timeline

• Study Start: 2000-08
• Study First Submitted: 2003-08-25
• Study First Submitted QC: 2003-08-25
• Study First Posted: 2003-08-26
• Primary Completion: 2003-09
• Study Completion: 2003-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-28
• Last Update Posted: 2014-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 228

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Total Body Bone Mineral Density (TBBMD)	Baseline, 1 year, and 2 years	Changes in TBBMD as measured by DEXA at baseline, 1 year, and 2 years

Secondary Outcome Measures

Name	Time	Method
Serum osteocalcin, alkaline phosphatase, and urinary n-telopeptide	Baseline, 1 year, and 2 years	Biologic measures of bone metabolism
Plasma carotenoids and red cell folate	Baseline, 1 year, and 2 years	Biologic measures of dietary change

Trial Locations

Locations (1)

Kaiser Permanente Center for Health Research; 🇺🇸 Portland, Oregon, United States