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?
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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