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

20. november 2018 oppdatert 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

Studieoversikt

Status

Fullført

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

33

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Glasgow, Storbritannia
        • NHS Greater Glasgow and Clyde

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

25 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Kontrollgruppe
Vanlig omsorg
Eksperimentell: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Glycaemic control
Tidsramme: Baseline to 12 weeks
Change in HbA1c
Baseline to 12 weeks

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

  • Studieleder: Lorna Paul, PhD, Glasgow Caledonian University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

6. november 2017

Primær fullføring (Faktiske)

22. august 2018

Studiet fullført (Faktiske)

22. august 2018

Datoer for studieregistrering

Først innsendt

27. juni 2017

Først innsendt som oppfylte QC-kriteriene

27. juni 2017

Først lagt ut (Faktiske)

29. juni 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. november 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. november 2018

Sist bekreftet

1. november 2018

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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