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Completed

NCT Number: NCT00067600

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

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.

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Key information

Age range

14 year–16 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet with increased fruits, vegetables, and calcium

Behavioral

Increased high impact activity and resistance training

Behavioral

Primary outcomes

  1. 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

Secondary outcomes

  1. Serum osteocalcin, alkaline phosphatase, and urinary n-telopeptide

    Time frame: Baseline, 1 year, and 2 years

    Biologic measures of bone metabolism

  2. Plasma carotenoids and red cell folate

    Time frame: Baseline, 1 year, and 2 years

    Biologic measures of dietary change

Sponsors and collaborators

Lead sponsor

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

Nih

Registry information

Official study title

Lifestyle Changes to Increase Bone Density in Teen Girls

Important dates

Study start
2000
Primary completion
2003
Study completion
2003
First posted
Aug 26, 2003
Registry last updated
Oct 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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