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

Osteoporosis Clinical Trial

Official title:

Lifestyle Changes to Increase Bone Density in Teen Girls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00067600
• Other study ID #: R01HD037744
• Status: Completed
• Phase: Phase 1
• First received: August 25, 2003
• Last updated: October 28, 2014
• Start date: August 2000
• Est. completion date: September 2003

Study information

• Verified date: October 2014
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: September 2003
• Est. primary completion date: September 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 16 Years

Eligibility

Inclusion Criteria

• High school freshman or sophomore

• Body mass index (BMI) from 16 through 23

• Member of Kaiser Permanente Northwest Health Plan

• Parent or guardian willing to participate

Exclusion Criteria

• Co-morbidity requiring a specific diet

• Medication which contraindicates consuming a high-fiber diet

• Life-threatening disease or other condition that would interfere with study participation

• Current or past medically or self-diagnosed eating disorder

• Current behaviors consistent with eating-related disorder

• Pregnancy

• Diagnosis of psychological disorder or difficulty within the past year

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Behavioral:
• Diet with increased fruits, vegetables, and calcium

• Increased high impact activity and resistance training

Locations

Country	Name	City	State
United States	Kaiser Permanente Center for Health Research	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Body Bone Mineral Density (TBBMD)	Changes in TBBMD as measured by DEXA at baseline, 1 year, and 2 years	Baseline, 1 year, and 2 years	No
Secondary	Serum osteocalcin, alkaline phosphatase, and urinary n-telopeptide	Biologic measures of bone metabolism	Baseline, 1 year, and 2 years	No
Secondary	Plasma carotenoids and red cell folate	Biologic measures of dietary change	Baseline, 1 year, and 2 years	No