Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00067600
Status:
COMPLETED
Last Update Posted:
2014-10-29
First Post:
2003-08-25
Brief Title:
Improving Bone Health in Adolescent Girls The Youth Osteoporosis and Understanding Total Health YOUTH Study
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Lifestyle Changes to Increase Bone Density in Teen Girls
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None