Diabetes Mellitus, Type 2NCT03203278
Web-based Exercise for South Asian People With Type 2 Diabetes
A study testing Web-based exercise programme in people with Diabetes Mellitus, Type 2, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Web-based exercise programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Nov 2017to 22 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Web-based exercise programme
- Keywords
- South Asian
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based exercise programmeBehavioural
Aerobic, resistance and balance exercises
| Study group | Role | What they receive |
|---|---|---|
| Web-based exercise programme | Experimental | Personalised exercise programme, undertaken three times a week (with no more than two rest days between sessions) for 12 weeks Receives: Behavioral: Web-based exercise programme |
| Control group | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycaemic control
Change in HbA1c
Measured: Baseline to 12 weeks
Secondary outcomes (28)
Blood lipid profile (cholesterol)
Change in total cholesterol level
Measured: Baseline to 12 weeks
Blood lipid profile (cholesterol)
Change in total cholesterol level
Measured: 12 weeks to 20 weeks
Blood lipid profile (high density lipoproteins)
Change in high density lipoprotein (HDL) level
Measured: Baseline to 12 weeks
Blood lipid profile (high density lipoproteins)
Change in high density lipoprotein (HDL) level
Measured: 12 weeks to 20 weeks
Blood lipid profile (low-density lipoproteins)
Change in low density lipoprotein (LDL) level
Measured: Baseline to 12 weeks
Blood lipid profile (low-density lipoproteins)
Change in low density lipoprotein (LDL) level
Measured: 12 weeks to 20 weeks
Blood lipid profile (triglyceride)
Change in triglyceride level
Measured: Baseline to 12 weeks
Blood lipid profile (triglyceride)
Change in triglyceride level
Measured: 12 weeks to 20 weeks
Blood pressure
Change in blood pressure result
Measured: Baseline to 12 weeks
Blood pressure
Change in blood pressure result
Measured: 12 weeks to 20 weeks
Body mass index (BMI)
Change in BMI
Measured: Baseline to 12 weeks
Body mass index (BMI)
Change in BMI
Measured: 12 weeks to 20 weeks
Waist circumference
Change in waist circumference
Measured: Baseline to 12 weeks
Waist circumference
Change in waist circumference
Measured: 12 weeks to 20 weeks
Ten metre walking test (10MWT)
Change in 10 MWT result
Measured: Baseline to 12 weeks
Ten metre walking test (10MWT)
Change in 10 MWT result
Measured: 12 weeks to 20 weeks
Timed Up and Go test
Change in Timed Up and Go test result
Measured: Baseline to 12 weeks
Timed Up and Go test
Change in Timed Up and Go test result
Measured: 12 weeks to 20 weeks
Muscle power
Change in hand grip dynamometer score
Measured: Baseline to 12 weeks
Muscle power
Change in hand grip dynamometer score
Measured: 12 weeks to 20 weeks
Quality of Life - WHO-QOL BREF score
Change in World Health Organisation Quality of Life (WHO-QOL BREF) score
Measured: Baseline to 12 weeks
Quality of Life - WHO-QOL BREF score
Change in World Health Organisation Quality of Life (WHO-QOL BREF) score
Measured: 12 weeks to 20 weeks
Adherence - exercise diary completion
Number of times exercise diary completed
Measured: 12 weeks
Dietary intake
Change in Food Frequency Questionnaire score
Measured: Baseline to 12 weeks
Dietary intake
Change in Food Frequency Questionnaire score
Measured: 12 weeks to 20 weeks
Change in Medication
Change in medication
Measured: Baseline to 12 weeks
Change in Medication
Change in medication
Measured: 12 weeks to 20 weeks
Glycaemic control
Change in HbA1c
Measured: 12 weeks to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start6 Nov 2017
- Primary completion22 Aug 2018
- Study completion22 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Lorna Paul, PhD, Study director, Glasgow Caledonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203278
- Sponsor's protocol ID
- GN17DI329
- Status last verified
- Nov 2018
- First submitted
- 27 Jun 2017
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Exercise Intervention for South Asian People With Type 2 Diabetes: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03203278
- Acronym / sponsor ID
- GN17DI329
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- South Asian
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 22 Aug 2018 (actual)
- Study completion
- 22 Aug 2018 (actual)
- First posted
- 29 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based exercise programme | Experimental | Behavioral: Web-based exercise programmePersonalised exercise programme, undertaken three times a week (with no more than two rest days between sessions) for 12 weeks |
| Control group | No intervention | –Usual care |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based exercise programmeAerobic, resistance and balance exercises | Behavioural | Web-based exercise programme |
Primary outcome
Glycaemic control
Time frame: Baseline to 12 weeks
Change in HbA1c
28 secondary outcomes
Blood lipid profile (cholesterol)
Time frame: Baseline to 12 weeks
Blood lipid profile (cholesterol)
Time frame: 12 weeks to 20 weeks
Blood lipid profile (high density lipoproteins)
Time frame: Baseline to 12 weeks
Blood lipid profile (high density lipoproteins)
Time frame: 12 weeks to 20 weeks
Blood lipid profile (low-density lipoproteins)
Time frame: Baseline to 12 weeks
Blood lipid profile (low-density lipoproteins)
Time frame: 12 weeks to 20 weeks
Blood lipid profile (triglyceride)
Time frame: Baseline to 12 weeks
Blood lipid profile (triglyceride)
Time frame: 12 weeks to 20 weeks
Blood pressure
Time frame: Baseline to 12 weeks
Blood pressure
Time frame: 12 weeks to 20 weeks
Body mass index (BMI)
Time frame: Baseline to 12 weeks
Body mass index (BMI)
Time frame: 12 weeks to 20 weeks
Waist circumference
Time frame: Baseline to 12 weeks
Waist circumference
Time frame: 12 weeks to 20 weeks
Ten metre walking test (10MWT)
Time frame: Baseline to 12 weeks
Ten metre walking test (10MWT)
Time frame: 12 weeks to 20 weeks
Timed Up and Go test
Time frame: Baseline to 12 weeks
Timed Up and Go test
Time frame: 12 weeks to 20 weeks
Muscle power
Time frame: Baseline to 12 weeks
Muscle power
Time frame: 12 weeks to 20 weeks
Quality of Life - WHO-QOL BREF score
Time frame: Baseline to 12 weeks
Quality of Life - WHO-QOL BREF score
Time frame: 12 weeks to 20 weeks
Adherence - exercise diary completion
Time frame: 12 weeks
Dietary intake
Time frame: Baseline to 12 weeks
Dietary intake
Time frame: 12 weeks to 20 weeks
Change in Medication
Time frame: Baseline to 12 weeks
Change in Medication
Time frame: 12 weeks to 20 weeks
Glycaemic control
Time frame: 12 weeks to 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorna Paul, PhD study director
Glasgow Caledonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based exercise programme in people with Diabetes Mellitus, Type 2, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycaemic control (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2018.