Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Web-based Exercise Intervention for South Asian People With Type 2 Diabetes: a Randomised Controlled Trial
This randomised controlled trial aims to investigate the effect of a 12 week personalised exercise programme delivered using a web-based platform, compared to usual care, on glycaemic control, muscle strength, functional ability, blood lipid profile, blood pressure and quality of life in adult South Asians with Type 2 Diabetes Mellitus
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.
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