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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Glasgow、イギリス
- NHS Greater Glasgow and Clyde
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：対照群
普段のお手入れ
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Glycaemic control
時間枠：Baseline to 12 weeks
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Change in HbA1c
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Baseline to 12 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Blood lipid profile (cholesterol)
時間枠：Baseline to 12 weeks
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Change in total cholesterol level
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Baseline to 12 weeks
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Blood lipid profile (cholesterol)
時間枠：12 weeks to 20 weeks
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Change in total cholesterol level
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12 weeks to 20 weeks
|
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Blood lipid profile (high density lipoproteins)
時間枠：Baseline to 12 weeks
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Change in high density lipoprotein (HDL) level
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Baseline to 12 weeks
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Blood lipid profile (high density lipoproteins)
時間枠：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
|
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Blood lipid profile (low-density lipoproteins)
時間枠：Baseline to 12 weeks
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Change in low density lipoprotein (LDL) level
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Baseline to 12 weeks
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Blood lipid profile (low-density lipoproteins)
時間枠：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
|
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Blood lipid profile (triglyceride)
時間枠：Baseline to 12 weeks
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Change in triglyceride level
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Baseline to 12 weeks
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Blood lipid profile (triglyceride)
時間枠：12 weeks to 20 weeks
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Change in triglyceride level
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12 weeks to 20 weeks
|
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Blood pressure
時間枠：Baseline to 12 weeks
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Change in blood pressure result
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Baseline to 12 weeks
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Blood pressure
時間枠：12 weeks to 20 weeks
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Change in blood pressure result
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12 weeks to 20 weeks
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Body mass index (BMI)
時間枠：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)
時間枠：12 weeks to 20 weeks
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Change in BMI
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12 weeks to 20 weeks
|
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Waist circumference
時間枠：Baseline to 12 weeks
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Change in waist circumference
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Baseline to 12 weeks
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Waist circumference
時間枠：12 weeks to 20 weeks
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Change in waist circumference
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12 weeks to 20 weeks
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Ten metre walking test (10MWT)
時間枠：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)
時間枠：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
時間枠：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
時間枠：12 weeks to 20 weeks
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Change in Timed Up and Go test result
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12 weeks to 20 weeks
|
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Muscle power
時間枠：Baseline to 12 weeks
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Change in hand grip dynamometer score
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Baseline to 12 weeks
|
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Muscle power
時間枠：12 weeks to 20 weeks
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Change in hand grip dynamometer score
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12 weeks to 20 weeks
|
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Quality of Life - WHO-QOL BREF score
時間枠：Baseline to 12 weeks
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Change in World Health Organisation Quality of Life (WHO-QOL BREF) score
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Baseline to 12 weeks
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Quality of Life - WHO-QOL BREF score
時間枠：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
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Adherence - exercise diary completion
時間枠：12 weeks
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Number of times exercise diary completed
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12 weeks
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Dietary intake
時間枠：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
時間枠：12 weeks to 20 weeks
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Change in Food Frequency Questionnaire score
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12 weeks to 20 weeks
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Change in Medication
時間枠：Baseline to 12 weeks
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Change in medication
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Baseline to 12 weeks
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Change in Medication
時間枠：12 weeks to 20 weeks
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Change in medication
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12 weeks to 20 weeks
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Glycaemic control
時間枠：12 weeks to 20 weeks
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Change in HbA1c
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12 weeks to 20 weeks
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協力者と研究者
捜査官
- スタディディレクター：Lorna Paul, PhD、Glasgow Caledonian University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。