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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

August 25, 2003
October 28, 2014
August 2000
September 2003   (final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT00067600 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
Improving Bone Health in Adolescent Girls: The Youth Osteoporosis and Understanding Total Health (YOUTH) Study
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Osteoporosis
  • Behavioral: Diet with increased fruits, vegetables, and calcium
  • Behavioral: Increased high impact activity and resistance training
Not Provided
DeBar LL, Ritenbaugh C, Aickin M, Orwoll E, Elliot D, Dickerson J, Vuckovic N, Stevens VJ, Moe E, Irving LM. Youth: a health plan-based lifestyle intervention increases bone mineral density in adolescent girls. Arch Pediatr Adolesc Med. 2006 Dec;160(12):1269-76. Erratum in: Arch Pediatr Adolesc Med. 2007 Feb;161(2):130.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
228
September 2003
September 2003   (final data collection date for primary outcome measure)

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
Female
14 Years to 16 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00067600
R01HD37744
Not Provided
Not Provided
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Principal Investigator: Lynn L DeBar, PhD, MPH Kaiser Permanente
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP