Improving Bone Health in Adolescent Girls: The Youth Osteoporosis and Understanding Total Health (YOUTH) Study
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 1 |
| 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 |
| Estimated Enrollment: | 228 |
| Study Start Date: | August 2000 |
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 |
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 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):
| 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 May 19, 2013