跳至主要内容
临床试验/NCT00273260
NCT00273260已完成2 期

The Effect on Behavior and Bone Mineral Density of Individualized Bone Mineral Density Feedback and Educational Interventions in Premenopausal Women: a Randomized Controlled Trial.

Menzies Institute for Medical Research1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2000年1月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
400
试验地点
1
主要终点
Bone mineral density

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
25 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •women aged between 25 and 44 years of age

排除标准

  • •previous had measurement of bone densitometry
  • •thyroid disease
  • •renal failure
  • •malignancy
  • •rheumatoid arthritis
  • •history of hysterectomy
  • •hormone replacement therapy
  • •were pregnant or planning pregnancy within 2 years of study entry
  • •lactating.

结局指标

主要结局

Bone mineral density

次要结局

  • physical activity
  • dietary calcium intake
  • calcium supplement use
  • smoking status

研究者

发起方
Menzies Institute for Medical Research
申办方类型
Other

研究点 (1)

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