Web-based Dietary Intervention for Diabetic Patients (myDIDeA)
Dietary Intervention Among Patients With Type 2 Diabetes Mellitus: An e-Approach
The Internet holds promise for a wide-scale promotion of dietary and lifestyle behavioural change. Website-delivered interventions have a potentially broad population reach as it is available 24 hours, and could be hosted by both government and non-governmental agencies. To date, there is no published study focused on dietary behaviour change in adults with Type 2 Diabetes Mellitus (T2DM) via a website-based system.
myDIDeA was a 12-months two-armed randomised controlled trial conducted in three tertiary public hospitals in Klang Valley, Malaysia. The primary outcome was the Dietary Knowledge, Attitude and Behaviour (DKAB) score, while the secondary outcomes included the food intake, anthropometry measurements, blood pressure and resting heart rate, blood biomarkers and the Dietary Stages of Change (DSOC) score.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Selangor
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Batu Caves、Selangor、马来西亚、68100
- Hospital Selayang
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Kajang、Selangor、马来西亚、43000
- Hospital Serdang
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Wilayah Persekutuan Putrajaya
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Putrajaya、Wilayah Persekutuan Putrajaya、马来西亚、62250
- Hospital Putrajaya
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Mentally sound men and women who are > 18 years old.
- Literate with a fair command of English and/or Malay languages.
- Have access to the Internet at home, work or public place.
- Willing to access the web portal at least once every fortnight.
- Have been confirmed to have HbA1c of >7%.
- KAB score < 50% at baseline.
Exclusion Criteria:
- Pregnant, lactating or intend to become pregnant during the study period.
- Diagnosed with Type 1 Diabetes Mellitus (T1DM) or Gestational Diabetes Mellitus (GDM)
- Weighing not more than 150% of the desired weight for height.
- Any pre-existing condition compromising the quality of life or ability to participate according to protocol.
- Have severe complications (chronic heart disease, cerebrovascular disease, diagnosed HIV/AIDS, cancer, emphysema, chronic liver or kidney disease) that would affect the subjects' ability to follow the tailored advice.
- Enrolled in other clinical studies.
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:e-Intervention group
Receive stage-specific dietary intervention via the website & standard care at the outpatient clinic.
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Dietary educational programme developed using Transtheoretical Model of Change and delivered via a website specific for Type 2 Diabetes patients.
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无干预:Control group
Continue with the standard diabetes care at the outpatient clinic without getting access to the web-based intervention.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from Baseline in Dietary KAB Score at 6 months
大体时间:Baseline & 6 months
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Dietary Knowledge, Attitude & Behaviour Score - assessed using 36-item questionnaire.
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Baseline & 6 months
|
|
Change from Baseline in Dietary KAB Score at 12 months
大体时间:Baseline & 12 months
|
Dietary Knowledge, Attitude & Behaviour Score - assessed using 36-item questionnaire.
|
Baseline & 12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from Baseline in anthropometric measurements at 6 months
大体时间:Baseline & 6 months
|
BMI, body fat percentage, waist circumference
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Baseline & 6 months
|
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Change from Baseline in anthropometric measurements at 12 months
大体时间:Baseline & 12 months
|
BMI, body fat percentage, waist circumference
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Baseline & 12 months
|
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Change from Baseline in dietary practices at 6 months
大体时间:Baseline & 6 months
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Nutrient intake, dietary GI, supplement intake, food preparation & eating out habit
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Baseline & 6 months
|
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Change from Baseline in dietary practices at 12 months
大体时间:Baseline & 12 months
|
Nutrient intake, dietary GI, supplement intake, food preparation & eating out habit
|
Baseline & 12 months
|
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Change from Baseline in blood biomarkers at 6 months
大体时间:Baseline & 6 months
|
HbA1c, fasting plasma glucose, lipid profile (data to be obtained from the medical records)
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Baseline & 6 months
|
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Change from Baseline in blood biomarkers at 12 months
大体时间:Baseline & 12 months
|
HbA1c, fasting plasma glucose, lipid profile (data to be obtained from the medical records)
|
Baseline & 12 months
|
合作者和调查者
调查人员
- 首席研究员:Kia Fatt Quek, PhD、Monash University (Sunway Campus)
出版物和有用的链接
一般刊物
- Ramadas A, Chan CKY, Oldenburg B, Hussein Z, Quek KF. Randomised-controlled trial of a web-based dietary intervention for patients with type 2 diabetes: changes in health cognitions and glycemic control. BMC Public Health. 2018 Jun 8;18(1):716. doi: 10.1186/s12889-018-5640-1.
- Ramadas A, Quek KF, Chan CK, Oldenburg B, Hussein Z. Randomised-controlled trial of a web-based dietary intervention for patients with type 2 diabetes mellitus: study protocol of myDIDeA. BMC Public Health. 2011 May 21;11:359. doi: 10.1186/1471-2458-11-359.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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