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

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ClinicalTrials.gov Identifier: NCT03203278
Recruitment Status : Recruiting
First Posted : June 29, 2017
Last Update Posted : April 9, 2018
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

Brief 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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Web-based exercise programme Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Web-based Exercise Intervention for South Asian People With Type 2 Diabetes: a Randomised Controlled Trial
Actual Study Start Date : November 6, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Web-based exercise programme
Personalised exercise programme, undertaken three times a week (with no more than two rest days between sessions) for 12 weeks
Behavioral: Web-based exercise programme
Aerobic, resistance and balance exercises

No Intervention: Control group
Usual care



Primary Outcome Measures :
  1. Glycaemic control [ Time Frame: Baseline to 12 weeks ]
    Change in HbA1c


Secondary Outcome Measures :
  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 [ Time Frame: Baseline to 12 weeks ]
    Change in World Health Organisation Quality of Life (WHO-QOL BREF) score

  22. Quality of Life [ 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



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03203278


Contacts
Contact: Hani Albalawi, BSc MSc +44 (0) 141 330 6813 h.albalawi.1@research.gla.ac.uk
Contact: Rhian Noble-Jones, PhD Rhian.Noble-Jones@glasgow.ac.uk

Locations
United Kingdom
NHS Greater Glasgow and Clyde Recruiting
Glasgow, United Kingdom
Contact: Hani Albalawi         
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
Investigators
Study Director: Lorna Paul, PhD Glasgow Caledonian University

Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT03203278     History of Changes
Other Study ID Numbers: GN17DI329
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by NHS Greater Glasgow and Clyde:
South Asian

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases