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临床试验/ACTRN12616000397415
ACTRN12616000397415进行中(未招募)不适用

Can collaborative care (including lifestyle intervention) prevent progression from pre-diabetes to Type 2 diabetes in people with comorbid depression in primary health care?

Western Sydney University0 个研究点目标入组 20 人开始时间: 2016年3月29日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Prevention

入排标准

年龄范围
40 Years 至 74 Years(—)
性别
All

入选标准

  • We will include participants meeting all of the following criteria:
  • 1. Give freely written informed consent
  • 2. Aged 40 to 74 years; the arbitrary lower age limit was chosen because of the sharp rise in the prevalence and incidence of diabetes in middle-aged Australians. The arbitrary upper age limit of 74 years was chosen because of the sharp rise in deaths in Australians aged 75 years or older
  • 3. At least overweight defined by body mass index greater than or equal to 25 kg/m2 computed from measured height and weight
  • 4. Confirmed pre-diabetes defined by impaired fasting glucose (IFG) (FPG levels plasma glucose levels 5.6–6.9mmol/L), or impaired glucose tolerance (IGT) (2-h PG Oral Glucose Tolerance Test [OGTT] levels of 7.8–11.0mmol/L), or HbA1c levels 5.7–6.4% according to the American Diabetes Association (ADA) criteria; pre-diabetes patients treated with Metformin are eligible
  • 5. Clinically significant depression (using scores greater than or equal to 10 for moderate to severe symptoms) with the Patient Health Questionnaire-9 (PHQ-9)
  • 6. Be at either (1) pre-contemplation, (2) contemplation, or (3) preparation stage of readiness to lose weight using the following question and response options based on the Prochaska Stage of Behavior Change model

排除标准

  • 1.Diabetes (type 1 or monogenic or type 2 or gestational diabetes) determined by self-report (doctor diagnosis or prescriptions for anti-diabetes medications)
  • 2.Current or previous psychotic symptoms by standard medical history/self-report
  • 3.Currently receiving treatment for breast, liver cancer or other malignancy, which could affect compliance with the protocol or interpretation of study results. Non-melanoma skin cancer(s) treated with curative intent are eligible
  • 4.Unable to communicate effectively in English judged by the Investigator during face-to-face or telephone contact to screen for study eligibility
  • 5.Current or planned pregnancy

研究者

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