NCT05279326招募中不适用
Virtual Shared Medical Appointments (SMAs) in Lifestyle Approach for Type 2 Diabetes: Protocol of a Randomized Pragmatic Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Change in glycaemic management, to be assessed by blood analysis
研究概览
简要总结
This study protocol presents the design of a randomized pragmatic trial. This study aims to determine the effectiveness of virtual shared medical appointments (SMAs) lifestyle approach in improving glycaemic control, compared to usual care in type 2 diabetes (T2D) subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) be 18 years old or older
- •(2) have a diagnosis of T2D with HbA1c ≥ 6.5% within the preceding 6 months
- •(3) have body mass index (BMI) ≥ 25.0 kg/m2 within the preceding 6 months
- •(4) have access to a camera and internet
排除标准
- •unable to attend virtual SMAs for diagnosis of dementia or other cognitive impairment and any behavioral problem, which interferes with group participation and discussion
- •not fluent in Portuguese, and unable to follow conversations, read instructions, and read in Portuguese
- •being pregnant or planning a pregnancy in the next year
- •attending a weight loss and/or physical activity counseling program
结局指标
主要结局
Change in glycaemic management, to be assessed by blood analysis
时间窗: 12 months
Difference between the intervention and control group in the change of serum glycated hemoglobin A1c (HbA1c) concentrations from baseline to the end of follow-up.
次要结局
- Change in fasting plasma low density lipoprotein (LDL) concentrations, to be assessed by blood analysis(12 months)
- Change in waist circumference, to be assessed by measuring tape(12 months)
- Change in the participants' satisfaction, to be assessed by questionnaire(12 months)
- Change in weight, to be assessed by weight balance(12 months)
- Change in systolic and diastolic blood pressure, to be assessed by sphygmomanometer(12 months)
- Change in fasting plasma triglycerides concentrations, to be assessed by blood analysis(12 months)
- Change in use of medication, to be assessed by electronic health record(12 months)
- Change in number of individual consultations, to be assessed by electronic health record(12 months)
- Change in fasting plasma high density lipoprotein (HDL) concentrations, to be assessed by blood analysis(12 months)
研究者
研究点 (2)
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