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

20. November 2018 aktualisiert von: 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

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

33

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

25 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: Kontrollgruppe
Übliche Pflege
Experimental: Web-based exercise programme
Personalised exercise programme, undertaken three times a week (with no more than two rest days between sessions) for 12 weeks
Verhalten: Web-based exercise programme
Aerobic, resistance and balance exercises

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Glycaemic control
Zeitfenster: Baseline to 12 weeks
Change in HbA1c
Baseline to 12 weeks

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

NHS Greater Glasgow and Clyde

Mitarbeiter

University of Glasgow

Ermittler

  • Studienleiter: Lorna Paul, PhD, Glasgow Caledonian University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

6. November 2017

Primärer Abschluss (Tatsächlich)

22. August 2018

Studienabschluss (Tatsächlich)

22. August 2018

Studienanmeldedaten

Zuerst eingereicht

27. Juni 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. Juni 2017

Zuerst gepostet (Tatsächlich)

29. Juni 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

23. November 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. November 2018

Zuletzt verifiziert

1. November 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • GN17DI329

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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