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Completed

NCT Number: NCT03203278

Web-based Exercise for South Asian People With Type 2 Diabetes

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

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Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Web-based exercise programme

Behavioral

Aerobic, resistance and balance exercises

Primary outcomes

  1. Glycaemic control

    Time frame: Baseline to 12 weeks

    Change in HbA1c

Secondary outcomes

  1. Blood lipid profile (cholesterol)

    Time frame: Baseline to 12 weeks

    Change in total cholesterol level

  2. Blood lipid profile (cholesterol)

    Time frame: 12 weeks to 20 weeks

    Change in total cholesterol level

  3. Blood lipid profile (high density lipoproteins)

    Time frame: Baseline to 12 weeks

    Change in high density lipoprotein (HDL) level

  4. Blood lipid profile (high density lipoproteins)

    Time frame: 12 weeks to 20 weeks

    Change in high density lipoprotein (HDL) level

  5. Blood lipid profile (low-density lipoproteins)

    Time frame: Baseline to 12 weeks

    Change in low density lipoprotein (LDL) level

  6. Blood lipid profile (low-density lipoproteins)

    Time frame: 12 weeks to 20 weeks

    Change in low density lipoprotein (LDL) level

  7. Blood lipid profile (triglyceride)

    Time frame: Baseline to 12 weeks

    Change in triglyceride level

  8. Blood lipid profile (triglyceride)

    Time frame: 12 weeks to 20 weeks

    Change in triglyceride level

  9. Blood pressure

    Time frame: Baseline to 12 weeks

    Change in blood pressure result

  10. Blood pressure

    Time frame: 12 weeks to 20 weeks

    Change in blood pressure result

  11. Body mass index (BMI)

    Time frame: Baseline to 12 weeks

    Change in BMI

  12. Body mass index (BMI)

    Time frame: 12 weeks to 20 weeks

    Change in BMI

  13. Waist circumference

    Time frame: Baseline to 12 weeks

    Change in waist circumference

  14. Waist circumference

    Time frame: 12 weeks to 20 weeks

    Change in waist circumference

  15. Ten metre walking test (10MWT)

    Time frame: Baseline to 12 weeks

    Change in 10 MWT result

  16. Ten metre walking test (10MWT)

    Time frame: 12 weeks to 20 weeks

    Change in 10 MWT result

  17. Timed Up and Go test

    Time frame: Baseline to 12 weeks

    Change in Timed Up and Go test result

  18. Timed Up and Go test

    Time frame: 12 weeks to 20 weeks

    Change in Timed Up and Go test result

  19. Muscle power

    Time frame: Baseline to 12 weeks

    Change in hand grip dynamometer score

  20. Muscle power

    Time frame: 12 weeks to 20 weeks

    Change in hand grip dynamometer score

  21. Quality of Life - WHO-QOL BREF score

    Time frame: Baseline to 12 weeks

    Change in World Health Organisation Quality of Life (WHO-QOL BREF) score

  22. Quality of Life - WHO-QOL BREF score

    Time frame: 12 weeks to 20 weeks

    Change in World Health Organisation Quality of Life (WHO-QOL BREF) score

  23. Adherence - exercise diary completion

    Time frame: 12 weeks

    Number of times exercise diary completed

  24. Dietary intake

    Time frame: Baseline to 12 weeks

    Change in Food Frequency Questionnaire score

  25. Dietary intake

    Time frame: 12 weeks to 20 weeks

    Change in Food Frequency Questionnaire score

  26. Change in Medication

    Time frame: Baseline to 12 weeks

    Change in medication

  27. Change in Medication

    Time frame: 12 weeks to 20 weeks

    Change in medication

  28. Glycaemic control

    Time frame: 12 weeks to 20 weeks

    Change in HbA1c

Sponsors and collaborators

Lead sponsor

NHS Greater Glasgow and Clyde

Other

Collaborators

  • University of Glasgow

Registry information

Official study title

Web-based Exercise Intervention for South Asian People With Type 2 Diabetes: a Randomised Controlled Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 29, 2017
Registry last updated
Nov 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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