Web-based Exercise for South Asian People With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      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
    

Detailed description: 
      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.
    

Intervention name(s): Web-based exercise programme
Intervention type(s): Behavioral
Intervention description(s): Aerobic, resistance and balance exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: South Asian