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

This study is ongoing, but not recruiting participants.

Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00067600
  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 I

MedlinePlus related topics:   Osteoporosis   

Drug Information available for:   Calcium gluconate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Official Title:   Lifestyle Changes to Increase Bone Density in Teen Girls

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

Estimated Enrollment:   228
Study Start Date:   August 2000

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

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


Publications indexed to this study:

Study ID Numbers:   R01HD37744
First Received:   August 25, 2003
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00067600
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Musculoskeletal Diseases
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on November 30, 2008




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