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

October 28, 2014 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Lifestyle Changes to Increase Bone Density in Teen Girls

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

228

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Center for Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Body Bone Mineral Density (TBBMD)
Time Frame: Baseline, 1 year, and 2 years
Changes in TBBMD as measured by DEXA at baseline, 1 year, and 2 years
Baseline, 1 year, and 2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Lynn L DeBar, PhD, MPH, Kaiser Permanente

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2000

Primary Completion (Actual)

September 1, 2003

Study Completion (Actual)

September 1, 2003

Study Registration Dates

First Submitted

August 25, 2003

First Submitted That Met QC Criteria

August 25, 2003

First Posted (Estimate)

August 26, 2003

Study Record Updates

Last Update Posted (Estimate)

October 29, 2014

Last Update Submitted That Met QC Criteria

October 28, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01HD037744 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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