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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Web-based exercise programme
Sponsored by
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring South Asian

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NHS Greater Glasgow and Clyde

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Web-based exercise programme

Control group

Arm Description

Personalised exercise programme, undertaken three times a week (with no more than two rest days between sessions) for 12 weeks

Usual care

Outcomes

Primary Outcome Measures

Glycaemic control
Change in HbA1c

Secondary Outcome Measures

Blood lipid profile (cholesterol)
Change in total cholesterol level
Blood lipid profile (cholesterol)
Change in total cholesterol level
Blood lipid profile (high density lipoproteins)
Change in high density lipoprotein (HDL) level
Blood lipid profile (high density lipoproteins)
Change in high density lipoprotein (HDL) level
Blood lipid profile (low-density lipoproteins)
Change in low density lipoprotein (LDL) level
Blood lipid profile (low-density lipoproteins)
Change in low density lipoprotein (LDL) level
Blood lipid profile (triglyceride)
Change in triglyceride level
Blood lipid profile (triglyceride)
Change in triglyceride level
Blood pressure
Change in blood pressure result
Blood pressure
Change in blood pressure result
Body mass index (BMI)
Change in BMI
Body mass index (BMI)
Change in BMI
Waist circumference
Change in waist circumference
Waist circumference
Change in waist circumference
Ten metre walking test (10MWT)
Change in 10 MWT result
Ten metre walking test (10MWT)
Change in 10 MWT result
Timed Up and Go test
Change in Timed Up and Go test result
Timed Up and Go test
Change in Timed Up and Go test result
Muscle power
Change in hand grip dynamometer score
Muscle power
Change in hand grip dynamometer score
Quality of Life - WHO-QOL BREF score
Change in World Health Organisation Quality of Life (WHO-QOL BREF) score
Quality of Life - WHO-QOL BREF score
Change in World Health Organisation Quality of Life (WHO-QOL BREF) score
Adherence - exercise diary completion
Number of times exercise diary completed
Dietary intake
Change in Food Frequency Questionnaire score
Dietary intake
Change in Food Frequency Questionnaire score
Change in Medication
Change in medication
Change in Medication
Change in medication
Glycaemic control
Change in HbA1c

Full Information

First Posted
June 27, 2017
Last Updated
November 20, 2018
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
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1. Study Identification

Unique Protocol Identification Number
NCT03203278
Brief Title
Web-based Exercise for South Asian People With Type 2 Diabetes
Official Title
Web-based Exercise Intervention for South Asian People With Type 2 Diabetes: a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 6, 2017 (Actual)
Primary Completion Date
August 22, 2018 (Actual)
Study Completion Date
August 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
South Asian

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Web-based exercise programme
Arm Type
Experimental
Arm Description
Personalised exercise programme, undertaken three times a week (with no more than two rest days between sessions) for 12 weeks
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Web-based exercise programme
Intervention Description
Aerobic, resistance and balance exercises
Primary Outcome Measure Information:
Title
Glycaemic control
Description
Change in HbA1c
Time Frame
Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Blood lipid profile (cholesterol)
Description
Change in total cholesterol level
Time Frame
Baseline to 12 weeks
Title
Blood lipid profile (cholesterol)
Description
Change in total cholesterol level
Time Frame
12 weeks to 20 weeks
Title
Blood lipid profile (high density lipoproteins)
Description
Change in high density lipoprotein (HDL) level
Time Frame
Baseline to 12 weeks
Title
Blood lipid profile (high density lipoproteins)
Description
Change in high density lipoprotein (HDL) level
Time Frame
12 weeks to 20 weeks
Title
Blood lipid profile (low-density lipoproteins)
Description
Change in low density lipoprotein (LDL) level
Time Frame
Baseline to 12 weeks
Title
Blood lipid profile (low-density lipoproteins)
Description
Change in low density lipoprotein (LDL) level
Time Frame
12 weeks to 20 weeks
Title
Blood lipid profile (triglyceride)
Description
Change in triglyceride level
Time Frame
Baseline to 12 weeks
Title
Blood lipid profile (triglyceride)
Description
Change in triglyceride level
Time Frame
12 weeks to 20 weeks
Title
Blood pressure
Description
Change in blood pressure result
Time Frame
Baseline to 12 weeks
Title
Blood pressure
Description
Change in blood pressure result
Time Frame
12 weeks to 20 weeks
Title
Body mass index (BMI)
Description
Change in BMI
Time Frame
Baseline to 12 weeks
Title
Body mass index (BMI)
Description
Change in BMI
Time Frame
12 weeks to 20 weeks
Title
Waist circumference
Description
Change in waist circumference
Time Frame
Baseline to 12 weeks
Title
Waist circumference
Description
Change in waist circumference
Time Frame
12 weeks to 20 weeks
Title
Ten metre walking test (10MWT)
Description
Change in 10 MWT result
Time Frame
Baseline to 12 weeks
Title
Ten metre walking test (10MWT)
Description
Change in 10 MWT result
Time Frame
12 weeks to 20 weeks
Title
Timed Up and Go test
Description
Change in Timed Up and Go test result
Time Frame
Baseline to 12 weeks
Title
Timed Up and Go test
Description
Change in Timed Up and Go test result
Time Frame
12 weeks to 20 weeks
Title
Muscle power
Description
Change in hand grip dynamometer score
Time Frame
Baseline to 12 weeks
Title
Muscle power
Description
Change in hand grip dynamometer score
Time Frame
12 weeks to 20 weeks
Title
Quality of Life - WHO-QOL BREF score
Description
Change in World Health Organisation Quality of Life (WHO-QOL BREF) score
Time Frame
Baseline to 12 weeks
Title
Quality of Life - WHO-QOL BREF score
Description
Change in World Health Organisation Quality of Life (WHO-QOL BREF) score
Time Frame
12 weeks to 20 weeks
Title
Adherence - exercise diary completion
Description
Number of times exercise diary completed
Time Frame
12 weeks
Title
Dietary intake
Description
Change in Food Frequency Questionnaire score
Time Frame
Baseline to 12 weeks
Title
Dietary intake
Description
Change in Food Frequency Questionnaire score
Time Frame
12 weeks to 20 weeks
Title
Change in Medication
Description
Change in medication
Time Frame
Baseline to 12 weeks
Title
Change in Medication
Description
Change in medication
Time Frame
12 weeks to 20 weeks
Title
Glycaemic control
Description
Change in HbA1c
Time Frame
12 weeks to 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorna Paul, PhD
Organizational Affiliation
Glasgow Caledonian University
Official's Role
Study Director
Facility Information:
Facility Name
NHS Greater Glasgow and Clyde
City
Glasgow
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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

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