Improving Bone Health in Adolescent Girls: The Youth Osteoporosis and Understanding Total Health (YOUTH) Study
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.
Behavioral: Diet with increased fruits, vegetables, and calcium
Behavioral: Increased high impact activity and resistance training
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Lifestyle Changes to Increase Bone Density in Teen Girls|
- Total Body Bone Mineral Density (TBBMD) [ Time Frame: Baseline, 1 year, and 2 years ] [ Designated as safety issue: No ]Changes in TBBMD as measured by DEXA at baseline, 1 year, and 2 years
- Serum osteocalcin, alkaline phosphatase, and urinary n-telopeptide [ Time Frame: Baseline, 1 year, and 2 years ] [ Designated as safety issue: No ]Biologic measures of bone metabolism
- Plasma carotenoids and red cell folate [ Time Frame: Baseline, 1 year, and 2 years ] [ Designated as safety issue: No ]Biologic measures of dietary change
|Study Start Date:||August 2000|
|Study Completion Date:||September 2003|
|Primary Completion Date:||September 2003 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00067600
|United States, Oregon|
|Kaiser Permanente Center for Health Research|
|Portland, Oregon, United States, 97227|
|Principal Investigator:||Lynn L DeBar, PhD, MPH||Kaiser Permanente|