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

20 november 2018 uppdaterad av: NHS Greater Glasgow and Clyde

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

Studieöversikt

Status

Avslutad

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

33

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Glasgow, Storbritannien
        • NHS Greater Glasgow and Clyde

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

25 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Kontrollgrupp
Vanlig skötsel
Experimentell: Web-based exercise programme
Personalised exercise programme, undertaken three times a week (with no more than two rest days between sessions) for 12 weeks
Aerobic, resistance and balance exercises

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Glycaemic control
Tidsram: Baseline to 12 weeks
Change in HbA1c
Baseline to 12 weeks

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Samarbetspartners

Utredare

  • Studierektor: Lorna Paul, PhD, Glasgow Caledonian University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

6 november 2017

Primärt slutförande (Faktisk)

22 augusti 2018

Avslutad studie (Faktisk)

22 augusti 2018

Studieregistreringsdatum

Först inskickad

27 juni 2017

Först inskickad som uppfyllde QC-kriterierna

27 juni 2017

Första postat (Faktisk)

29 juni 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 november 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

20 november 2018

Senast verifierad

1 november 2018

Mer information

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