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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2003 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Recruitment status was Active, not recruiting

First Received on August 25, 2003. Last Updated on June 23, 2005 History of Changes

Sponsor:	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

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:

MedlinePlus related topics: Bone Density Osteoporosis

U.S. FDA Resources

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

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

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):

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.

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

Additional relevant MeSH terms:

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on February 09, 2012