Web-based Exercise for South Asian People With Type 2 Diabetes
NCT ID: NCT03203278
Last Updated: 2018-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2017-11-06
2018-08-22
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Web-based exercise programme
Personalised exercise programme, undertaken three times a week (with no more than two rest days between sessions) for 12 weeks
Web-based exercise programme
Aerobic, resistance and balance exercises
Control group
Usual care
No interventions assigned to this group
Interventions
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Web-based exercise programme
Aerobic, resistance and balance exercises
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
25 Years
65 Years
ALL
No
Sponsors
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University of Glasgow
OTHER
NHS Greater Glasgow and Clyde
OTHER
Responsible Party
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Principal Investigators
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Lorna Paul, PhD
Role: STUDY_DIRECTOR
Glasgow Caledonian University
Locations
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NHS Greater Glasgow and Clyde
Glasgow, , United Kingdom
Countries
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Other Identifiers
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GN17DI329
Identifier Type: -
Identifier Source: org_study_id
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