Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000413
Status:
COMPLETED
Last Update Posted:
2006-12-29
First Post:
1999-11-03
Brief Title:
Osteoporosis Prevention in Preadolescent Girls
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Study Overview
Official Title:
Osteoporosis Prevention in Preadolescent Girls
Status:
COMPLETED
Status Verified Date:
2003-02
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:
This study will test an osteoporosis prevention program aimed at preadolescent girls between the ages of 10 and 12 who have not yet started their menstrual periods Girls in this age group are adding large amounts of new bone to their skeletons Adding more bone at this time of life can reduce a persons chances of developing osteoporosis thinning bones in later years
We will look at how this osteoporosis prevention program affects the amount of calcium in the girls diets the amount of weight-bearing exercise they do and their bone mass measured using ultrasound testing of the heel
We will look at how this osteoporosis prevention program affects the amount of calcium in the girls diets the amount of weight-bearing exercise they do and their bone mass measured using ultrasound testing of the heel
Detailed Description:
The studys objective is to demonstrate the efficacy of a behavioraleducational intervention in increasing levels of dietary calcium intake and weight-bearing exercise within an at-risk population in a stage of rapid accrual of bone mass-specifically premenarchal girls between the ages of 10 and 12 We will use cluster randomization to randomize girls to either the intervention or a program of education only We will randomize eighteen groups of girls into each arm of the study
The intervention consists of six interactive sessions using various media ie overhead transparencies graphics and three-dimensional demonstrations to present instructional material Topics include an explanation of osteoporosis and its modifiable and nonmodifiable risk factors prevention of osteoporosis via healthy food choices ie high calcium low fat foods and prevention of osteoporosis via weight-bearing exercise Each girl monitors her own progress toward the goal of 1350 to 1500 milligrams of calcium per day A similar method allows simple self-monitoring of weight-bearing activity The intervention program is reinforced via monthly self-monitoring for 18 months The education-only program consists of six generic sessions on healthy eating physical fitness and healthy lifestyle choices
The primary outcomes of interest are higher calcium intake and higher levels of weight-bearing exercise A secondary outcome of interest is increased broadband ultrasound attenuation of the os calcis assessed using quantitative ultrasound In summary the group of girls targeted is ideal for this intervention because they are at a stage of rapid accrual of bone mass
The intervention consists of six interactive sessions using various media ie overhead transparencies graphics and three-dimensional demonstrations to present instructional material Topics include an explanation of osteoporosis and its modifiable and nonmodifiable risk factors prevention of osteoporosis via healthy food choices ie high calcium low fat foods and prevention of osteoporosis via weight-bearing exercise Each girl monitors her own progress toward the goal of 1350 to 1500 milligrams of calcium per day A similar method allows simple self-monitoring of weight-bearing activity The intervention program is reinforced via monthly self-monitoring for 18 months The education-only program consists of six generic sessions on healthy eating physical fitness and healthy lifestyle choices
The primary outcomes of interest are higher calcium intake and higher levels of weight-bearing exercise A secondary outcome of interest is increased broadband ultrasound attenuation of the os calcis assessed using quantitative ultrasound In summary the group of girls targeted is ideal for this intervention because they are at a stage of rapid accrual of bone mass
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAMS-018 | None | None | None |