Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-26 @ 12:38 AM
Study NCT ID:
NCT00273260
Status:
COMPLETED
Last Update Posted:
2006-05-09
First Post:
2006-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effectiveness of Individualised Bone Density Feedback and Osteoporosis Education in Premenopausal Women
Sponsor:
Menzies Institute for Medical Research
Organization:
Study Overview
Official Title:
The Effect on Behavior and Bone Mineral Density of Individualized Bone Mineral Density Feedback and Educational Interventions in Premenopausal Women: a Randomized Controlled Trial.
Status:
COMPLETED
Status Verified Date:
2006-01
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:
The purpose of this study is to determine whether giving women feedback concerning their bone mineral density, combined with either an information leaflet or group education concerning osteoporosis changes women's behavior and/or bone density.
Detailed Description:
Fractures due to osteoporosis are a major public health problem. Bone density is one of the major predictors of these osteoporotic fractures and is the result of the amount of bone gained in early life (i.e peak bone mass) and subsequent bone loss. Cigarette smoking, physical inactivity and inadequate calcium intake are widely regarded as risk factors for osteoporosis (as well as for other common diseases for the former two). Despite this information being widely available and actively promoted, the prevalence of these risk factors in the population remains unacceptably high. In women (mean age 33) taking part in a study of the determinants of bone mass in children, we recently reported substantial change in these behaviours at 12 months follow-up when women received an information leaflet and individualised bone density feedback. These women were highly selected and it is unclear if this response is representative of all women. With this study, we aim to test whether individualised bone density feedback, combined with either an information leaflet or small group education will change women's osteporosis preventive behaviors and/or bone density.
Specifically, we aimed to test the following hypotheses:
1. Women are more likely to change calcium intake and physical activity if their BMD is low.
2. Group education (in the form of the Osteoporosis Prevention and Self Management course) will be more efficacious at changing these lifestyle behaviours than an information leaflet alone.
3. Bone density feedback and educational intervention have independent effects on behavior and BMD change.
4. Women who improve their physical activity or dietary calcium intake will have a change in bone mass over 2 years that is 0.34-0.54% per annum better (depending on site and lifestyle factor) than those who do not alter their behaviour.
Specifically, we aimed to test the following hypotheses:
1. Women are more likely to change calcium intake and physical activity if their BMD is low.
2. Group education (in the form of the Osteoporosis Prevention and Self Management course) will be more efficacious at changing these lifestyle behaviours than an information leaflet alone.
3. Bone density feedback and educational intervention have independent effects on behavior and BMD change.
4. Women who improve their physical activity or dietary calcium intake will have a change in bone mass over 2 years that is 0.34-0.54% per annum better (depending on site and lifestyle factor) than those who do not alter their behaviour.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: