Clinical trial NCT03203278: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: South Asian
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: University of Glasgow
First posted: 2017-06-29
Enrollment: 33
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Glycaemic control
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Blood lipid profile (cholesterol)
timeFrame: Baseline to 12 weeks
measure: Blood lipid profile (cholesterol)
timeFrame: 12 weeks to 20 weeks
measure: Blood lipid profile (high density lipoproteins)
timeFrame: Baseline to 12 weeks
measure: Blood lipid profile (high density lipoproteins)
timeFrame: 12 weeks to 20 weeks
measure: Blood lipid profile (low-density lipoproteins)
timeFrame: Baseline to 12 weeks
measure: Blood lipid profile (low-density lipoproteins)
timeFrame: 12 weeks to 20 weeks
measure: Blood lipid profile (triglyceride)
timeFrame: Baseline to 12 weeks
measure: Blood lipid profile (triglyceride)
timeFrame: 12 weeks to 20 weeks
measure: Blood pressure
timeFrame: Baseline to 12 weeks
measure: Blood pressure
timeFrame: 12 weeks to 20 weeks
measure: Body mass index (BMI)
timeFrame: Baseline to 12 weeks
measure: Body mass index (BMI)
timeFrame: 12 weeks to 20 weeks
measure: Waist circumference
timeFrame: Baseline to 12 weeks
measure: Waist circumference
timeFrame: 12 weeks to 20 weeks
measure: Ten metre walking test (10MWT)
timeFrame: Baseline to 12 weeks
measure: Ten metre walking test (10MWT)
timeFrame: 12 weeks to 20 weeks
measure: Timed Up and Go test
timeFrame: Baseline to 12 weeks
measure: Timed Up and Go test
timeFrame: 12 weeks to 20 weeks
measure: Muscle power
timeFrame: Baseline to 12 weeks
measure: Muscle power
timeFrame: 12 weeks to 20 weeks
measure: Quality of Life - WHO-QOL BREF score
timeFrame: Baseline to 12 weeks
measure: Quality of Life - WHO-QOL BREF score
timeFrame: 12 weeks to 20 weeks
measure: Adherence - exercise diary completion
timeFrame: 12 weeks
measure: Dietary intake
timeFrame: Baseline to 12 weeks
measure: Dietary intake
timeFrame: 12 weeks to 20 weeks
measure: Change in Medication
timeFrame: Baseline to 12 weeks
measure: Change in Medication
timeFrame: 12 weeks to 20 weeks
measure: Glycaemic control
timeFrame: 12 weeks to 20 weeks
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
Study officials:
affiliation: Glasgow Caledonian University
name: Lorna Paul, PhD
role: STUDY_DIRECTOR
References: