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

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00067600
First received: August 25, 2003
Last updated: October 28, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Osteoporosis
Behavioral: Diet with increased fruits, vegetables, and calcium
Behavioral: Increased high impact activity and resistance training
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 228
Study Start Date: August 2000
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   14 Years to 16 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067600

Locations
United States, Oregon
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Investigators
Principal Investigator: Lynn L DeBar, PhD, MPH Kaiser Permanente
  More Information

No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00067600     History of Changes
Other Study ID Numbers: R01HD37744
Study First Received: August 25, 2003
Last Updated: October 28, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on November 25, 2014