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临床试验/NCT00969007
NCT00969007已完成不适用

Identification of Predictors of Success for Lifestyle Modifications in Overweight Pre-diabetic Subjects

Marie-France Langlois2 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2008年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
81
试验地点
2
主要终点
5% weight loss

研究概览

简要总结

The primary objective of the study is to identify baseline and early predictors of favorable and unfavorable response to lifestyle intervention. As a secondary objective, the investigators would like to validate our questionnaire or other identified predictors as clinical tools to guide us in selection of the most suitable candidates for lifestyle intervention programs. Assuming the same capacity of our questionnaire to predict an absence of weight loss (≥5%) or a loss to follow-up (likelihood ratio for a positive test, LR+ = 9.9), 70 subjects need to be included in this study in order to find a lower limit of the 95% confidence interval above 2.0 for this LR+, which is the limit of an acceptable test. The investigators will enroll participants with pre-diabetes and BMI 27-40 in our program and administer to them at baseline and at 3 months the designed questionnaire, as well as other already well validated questionnaires assessing state of change and readiness to implement diet or exercise modifications.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI between 27-40 kg/m2
  • impaired glucose tolerance, confirmed by an oral glucose tolerance test (OGTT = fasting glucose lower than 7.0 mmol/l and glucose 2 hours post 75g of glucose between 7.8-11.0 mmol/l), or impaired fasting glucose (6.1-6.9 mmol/L)
  • 18 years old or more
  • Being able to read and give an informed consent

排除标准

  • Conditions that affects weight or glucose metabolism

结局指标

主要结局

5% weight loss

时间窗: 1 year

次要结局

未报告次要终点

研究者

发起方
Marie-France Langlois
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Marie-France Langlois

MD

Université de Sherbrooke

研究点 (2)

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