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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03203278
• Other study ID #: GN17DI329
• Status: Completed
• Phase: N/A
• Start date: November 6, 2017
• Est. completion date: August 22, 2018

Study information

• Verified date: November 2018
• Source: NHS Greater Glasgow and Clyde
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 Diabetes Mellitus

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 22, 2018
• Est. primary completion date: August 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Web-based exercise programme
Aerobic, resistance and balance exercises

Locations

Country	Name	City	State
United Kingdom	NHS Greater Glasgow and Clyde	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycaemic control	Change in HbA1c	Baseline to 12 weeks
Secondary	Blood lipid profile (cholesterol)	Change in total cholesterol level	Baseline to 12 weeks
Secondary	Blood lipid profile (cholesterol)	Change in total cholesterol level	12 weeks to 20 weeks
Secondary	Blood lipid profile (high density lipoproteins)	Change in high density lipoprotein (HDL) level	Baseline to 12 weeks
Secondary	Blood lipid profile (high density lipoproteins)	Change in high density lipoprotein (HDL) level	12 weeks to 20 weeks
Secondary	Blood lipid profile (low-density lipoproteins)	Change in low density lipoprotein (LDL) level	Baseline to 12 weeks
Secondary	Blood lipid profile (low-density lipoproteins)	Change in low density lipoprotein (LDL) level	12 weeks to 20 weeks
Secondary	Blood lipid profile (triglyceride)	Change in triglyceride level	Baseline to 12 weeks
Secondary	Blood lipid profile (triglyceride)	Change in triglyceride level	12 weeks to 20 weeks
Secondary	Blood pressure	Change in blood pressure result	Baseline to 12 weeks
Secondary	Blood pressure	Change in blood pressure result	12 weeks to 20 weeks
Secondary	Body mass index (BMI)	Change in BMI	Baseline to 12 weeks
Secondary	Body mass index (BMI)	Change in BMI	12 weeks to 20 weeks
Secondary	Waist circumference	Change in waist circumference	Baseline to 12 weeks
Secondary	Waist circumference	Change in waist circumference	12 weeks to 20 weeks
Secondary	Ten metre walking test (10MWT)	Change in 10 MWT result	Baseline to 12 weeks
Secondary	Ten metre walking test (10MWT)	Change in 10 MWT result	12 weeks to 20 weeks
Secondary	Timed Up and Go test	Change in Timed Up and Go test result	Baseline to 12 weeks
Secondary	Timed Up and Go test	Change in Timed Up and Go test result	12 weeks to 20 weeks
Secondary	Muscle power	Change in hand grip dynamometer score	Baseline to 12 weeks
Secondary	Muscle power	Change in hand grip dynamometer score	12 weeks to 20 weeks
Secondary	Quality of Life - WHO-QOL BREF score	Change in World Health Organisation Quality of Life (WHO-QOL BREF) score	Baseline to 12 weeks
Secondary	Quality of Life - WHO-QOL BREF score	Change in World Health Organisation Quality of Life (WHO-QOL BREF) score	12 weeks to 20 weeks
Secondary	Adherence - exercise diary completion	Number of times exercise diary completed	12 weeks
Secondary	Dietary intake	Change in Food Frequency Questionnaire score	Baseline to 12 weeks
Secondary	Dietary intake	Change in Food Frequency Questionnaire score	12 weeks to 20 weeks
Secondary	Change in Medication	Change in medication	Baseline to 12 weeks
Secondary	Change in Medication	Change in medication	12 weeks to 20 weeks
Secondary	Glycaemic control	Change in HbA1c	12 weeks to 20 weeks