Web-based Exercise for South Asian People With Type 2 Diabetes
Web-based Exercise Intervention for South Asian People With Type 2 Diabetes: a Randomised Controlled Trial
研究概览
详细说明
A mixed method approach involving both qualitative and quantitative methods will be used.
The quantitative component will consist of a single blind, randomised controlled trial (RCT), which will explore the effects of the intervention on glycaemic control (blood sugar levels) and other secondary outcomes.
The qualitative component will consist of face to face interviews to explore the views of participants regarding acceptability and barriers affecting adherence to this intervention.
Potential participants will be informed about the study at hospital diabetes clinics, community health organisations, support groups, places of worship and General Practitioner (GP) surgeries. Recruitment is estimated to last for 9 months. Potential participants will be sent a participant information sheet (PIS) in either English or Urdu, depending on their preference. Those wishing to take part will meet the researcher at a convenient location, for eligibility screening and consent. If necessary, translation services can be arranged for those with limited English throughout the study.
Following baseline assessment, participants will be randomised to either the intervention or control group. Participants in the control group will be asked to continue their usual care and day to day physical activity routine. In addition, they will be given general information about diabetes management. Participants who wish to use the website for exercise will be provided with access at the end of all assessments.
Participants assigned to the intervention group will be asked to perform a personalised exercise programme, undertaken three times a week (with no more than two rest days between sessions) for 12 weeks. Participants will meet the researcher face to face immediately after randomisation. During this meeting, a brief physical assessment will be undertaken and exercise goals will be discussed and agreed with participants. The researcher will then design a personalised exercise programme for each participant using the resources available on the web-based exercise website. The exercise programme prescription and progression will be in line with American Diabetes Association (ADA) and American College of Sports Medicine (ACSM) guidelines (Colberg et al. 2016). The website (www.webbasedphysio.com) will be used to deliver the intervention. This website has been modified, in collaboration with South Asians, to be culturally suitable for people of South Asian backgrounds in terms of content and language (Albalawi et al, under review). The researcher will contact participants every two weeks via telephone to encourage use of the website, ask about progress, and to deal with any technical issues that they might face while using the website. Participants will be advised to contact the researcher to request a change in their programme or if a problem arises. The researcher will make changes remotely and participants will be informed of any changes by phone or email. Participants will be asked to meet the researcher face to face to discuss progression and goals at week 6 (midway). Regardless of groups allocation, all participants will be assessed three times by a blind assessor at baseline (week=0) , after the end of the intervention (week=12) and 8 weeks after the end of the intervention (week=20).
Assessment of outcome measures will take place at convenient locations and each visit should take no more than 90 minutes. Travel expenses will be provided.
All participants will be informed that they are free to withdraw from the study at any time without being obliged to give notice or provide any explanation. Any data collected before their withdrawal will be considered in the analysis.
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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Glasgow、英国
- NHS Greater Glasgow and Clyde
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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:
- define themselves as South Asians
- BMI 21 - 29.9 kg/m2
- diagnosed with Type 2 Diabetes Mellitus (T2DM) by a physician more than 6 months previously
- access to a personal computer/tablet, smart phone or smart television with an email address and Internet connection
- able to understand English or Urdu
Exclusion Criteria:
- type 1 diabetes
- any medical conditions that would affect adherence or contraindicate exercise including severe peripheral neuropathy, severe autonomic neuropathy, severe physical limitations, heart disease, pre-proliferative or proliferative retinopathy, uncontrolled hypertension (>180/ 100mmHg), or coronary artery disease.
- people using insulin if they do not have a self-monitoring glucose device or are unable to use such devices.
- engaging in exercise training of 150 minutes a week or more
- participating in other interventional studies aiming to improve glycaemic control
- unwilling to be randomised
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：控制组
日常护理
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实验性的：Web-based exercise programme
Personalised exercise programme, undertaken three times a week (with no more than two rest days between sessions) for 12 weeks
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Aerobic, resistance and balance exercises
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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 |
|---|---|---|
|
Glycaemic control
大体时间：Baseline to 12 weeks
|
Change in HbA1c
|
Baseline to 12 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Blood lipid profile (cholesterol)
大体时间：Baseline to 12 weeks
|
Change in total cholesterol level
|
Baseline to 12 weeks
|
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Blood lipid profile (cholesterol)
大体时间：12 weeks to 20 weeks
|
Change in total cholesterol level
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12 weeks to 20 weeks
|
|
Blood lipid profile (high density lipoproteins)
大体时间：Baseline to 12 weeks
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Change in high density lipoprotein (HDL) level
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Baseline to 12 weeks
|
|
Blood lipid profile (high density lipoproteins)
大体时间：12 weeks to 20 weeks
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Change in high density lipoprotein (HDL) level
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12 weeks to 20 weeks
|
|
Blood lipid profile (low-density lipoproteins)
大体时间：Baseline to 12 weeks
|
Change in low density lipoprotein (LDL) level
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Baseline to 12 weeks
|
|
Blood lipid profile (low-density lipoproteins)
大体时间：12 weeks to 20 weeks
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Change in low density lipoprotein (LDL) level
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12 weeks to 20 weeks
|
|
Blood lipid profile (triglyceride)
大体时间：Baseline to 12 weeks
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Change in triglyceride level
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Baseline to 12 weeks
|
|
Blood lipid profile (triglyceride)
大体时间：12 weeks to 20 weeks
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Change in triglyceride level
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12 weeks to 20 weeks
|
|
Blood pressure
大体时间：Baseline to 12 weeks
|
Change in blood pressure result
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Baseline to 12 weeks
|
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Blood pressure
大体时间：12 weeks to 20 weeks
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Change in blood pressure result
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12 weeks to 20 weeks
|
|
Body mass index (BMI)
大体时间：Baseline to 12 weeks
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Change in BMI
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Baseline to 12 weeks
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|
Body mass index (BMI)
大体时间：12 weeks to 20 weeks
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Change in BMI
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12 weeks to 20 weeks
|
|
Waist circumference
大体时间：Baseline to 12 weeks
|
Change in waist circumference
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Baseline to 12 weeks
|
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Waist circumference
大体时间：12 weeks to 20 weeks
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Change in waist circumference
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12 weeks to 20 weeks
|
|
Ten metre walking test (10MWT)
大体时间：Baseline to 12 weeks
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Change in 10 MWT result
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Baseline to 12 weeks
|
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Ten metre walking test (10MWT)
大体时间：12 weeks to 20 weeks
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Change in 10 MWT result
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12 weeks to 20 weeks
|
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Timed Up and Go test
大体时间：Baseline to 12 weeks
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Change in Timed Up and Go test result
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Baseline to 12 weeks
|
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Timed Up and Go test
大体时间：12 weeks to 20 weeks
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Change in Timed Up and Go test result
|
12 weeks to 20 weeks
|
|
Muscle power
大体时间：Baseline to 12 weeks
|
Change in hand grip dynamometer score
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Baseline to 12 weeks
|
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Muscle power
大体时间：12 weeks to 20 weeks
|
Change in hand grip dynamometer score
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12 weeks to 20 weeks
|
|
Quality of Life - WHO-QOL BREF score
大体时间：Baseline to 12 weeks
|
Change in World Health Organisation Quality of Life (WHO-QOL BREF) score
|
Baseline to 12 weeks
|
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Quality of Life - WHO-QOL BREF score
大体时间：12 weeks to 20 weeks
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Change in World Health Organisation Quality of Life (WHO-QOL BREF) score
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12 weeks to 20 weeks
|
|
Adherence - exercise diary completion
大体时间：12 weeks
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Number of times exercise diary completed
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12 weeks
|
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Dietary intake
大体时间：Baseline to 12 weeks
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Change in Food Frequency Questionnaire score
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Baseline to 12 weeks
|
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Dietary intake
大体时间：12 weeks to 20 weeks
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Change in Food Frequency Questionnaire score
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12 weeks to 20 weeks
|
|
Change in Medication
大体时间：Baseline to 12 weeks
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Change in medication
|
Baseline to 12 weeks
|
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Change in Medication
大体时间：12 weeks to 20 weeks
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Change in medication
|
12 weeks to 20 weeks
|
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Glycaemic control
大体时间：12 weeks to 20 weeks
|
Change in HbA1c
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12 weeks to 20 weeks
|
合作者和调查者
调查人员
- 研究主任：Lorna Paul, PhD、Glasgow Caledonian University
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 (实际的)
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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