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

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Diet with increased fruits, vegetables, and calcium
Increased high impact activity and resistance training
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis

Eligibility Criteria

14 Years - 16 Years (Child)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Kaiser Permanente Center for Health Research

Outcomes

Primary Outcome Measures

Total Body Bone Mineral Density (TBBMD)
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
Biologic measures of bone metabolism
Plasma carotenoids and red cell folate
Biologic measures of dietary change

Full Information

First Posted
August 25, 2003
Last Updated
October 28, 2014
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00067600
Brief Title
Improving Bone Health in Adolescent Girls: The Youth Osteoporosis and Understanding Total Health (YOUTH) Study
Official Title
Lifestyle Changes to Increase Bone Density in Teen Girls
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
September 2003 (Actual)
Study Completion Date
September 2003 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
228 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Diet with increased fruits, vegetables, and calcium
Intervention Type
Behavioral
Intervention Name(s)
Increased high impact activity and resistance training
Primary Outcome Measure Information:
Title
Total Body Bone Mineral Density (TBBMD)
Description
Changes in TBBMD as measured by DEXA at baseline, 1 year, and 2 years
Time Frame
Baseline, 1 year, and 2 years
Secondary Outcome Measure Information:
Title
Serum osteocalcin, alkaline phosphatase, and urinary n-telopeptide
Description
Biologic measures of bone metabolism
Time Frame
Baseline, 1 year, and 2 years
Title
Plasma carotenoids and red cell folate
Description
Biologic measures of dietary change
Time Frame
Baseline, 1 year, and 2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynn L DeBar, PhD, MPH
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Center for Health Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17146025
Citation
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. doi: 10.1001/archpedi.160.12.1269. Erratum In: Arch Pediatr Adolesc Med. 2007 Feb;161(2):130.
Results Reference
derived

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

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