Web-based Exercise for South Asian People With Type 2 Diabetes
Web-based Exercise Intervention for South Asian People With Type 2 Diabetes: a Randomised Controlled Trial
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
-
Glasgow, Zjednoczone Królestwo
- NHS Greater Glasgow and Clyde
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Brak interwencji: Grupa kontrolna
Zwykła opieka
|
|
|
Eksperymentalny: 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
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Glycaemic control
Ramy czasowe: Baseline to 12 weeks
|
Change in HbA1c
|
Baseline to 12 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Blood lipid profile (cholesterol)
Ramy czasowe: Baseline to 12 weeks
|
Change in total cholesterol level
|
Baseline to 12 weeks
|
|
Blood lipid profile (cholesterol)
Ramy czasowe: 12 weeks to 20 weeks
|
Change in total cholesterol level
|
12 weeks to 20 weeks
|
|
Blood lipid profile (high density lipoproteins)
Ramy czasowe: Baseline to 12 weeks
|
Change in high density lipoprotein (HDL) level
|
Baseline to 12 weeks
|
|
Blood lipid profile (high density lipoproteins)
Ramy czasowe: 12 weeks to 20 weeks
|
Change in high density lipoprotein (HDL) level
|
12 weeks to 20 weeks
|
|
Blood lipid profile (low-density lipoproteins)
Ramy czasowe: Baseline to 12 weeks
|
Change in low density lipoprotein (LDL) level
|
Baseline to 12 weeks
|
|
Blood lipid profile (low-density lipoproteins)
Ramy czasowe: 12 weeks to 20 weeks
|
Change in low density lipoprotein (LDL) level
|
12 weeks to 20 weeks
|
|
Blood lipid profile (triglyceride)
Ramy czasowe: Baseline to 12 weeks
|
Change in triglyceride level
|
Baseline to 12 weeks
|
|
Blood lipid profile (triglyceride)
Ramy czasowe: 12 weeks to 20 weeks
|
Change in triglyceride level
|
12 weeks to 20 weeks
|
|
Blood pressure
Ramy czasowe: Baseline to 12 weeks
|
Change in blood pressure result
|
Baseline to 12 weeks
|
|
Blood pressure
Ramy czasowe: 12 weeks to 20 weeks
|
Change in blood pressure result
|
12 weeks to 20 weeks
|
|
Body mass index (BMI)
Ramy czasowe: Baseline to 12 weeks
|
Change in BMI
|
Baseline to 12 weeks
|
|
Body mass index (BMI)
Ramy czasowe: 12 weeks to 20 weeks
|
Change in BMI
|
12 weeks to 20 weeks
|
|
Waist circumference
Ramy czasowe: Baseline to 12 weeks
|
Change in waist circumference
|
Baseline to 12 weeks
|
|
Waist circumference
Ramy czasowe: 12 weeks to 20 weeks
|
Change in waist circumference
|
12 weeks to 20 weeks
|
|
Ten metre walking test (10MWT)
Ramy czasowe: Baseline to 12 weeks
|
Change in 10 MWT result
|
Baseline to 12 weeks
|
|
Ten metre walking test (10MWT)
Ramy czasowe: 12 weeks to 20 weeks
|
Change in 10 MWT result
|
12 weeks to 20 weeks
|
|
Timed Up and Go test
Ramy czasowe: Baseline to 12 weeks
|
Change in Timed Up and Go test result
|
Baseline to 12 weeks
|
|
Timed Up and Go test
Ramy czasowe: 12 weeks to 20 weeks
|
Change in Timed Up and Go test result
|
12 weeks to 20 weeks
|
|
Muscle power
Ramy czasowe: Baseline to 12 weeks
|
Change in hand grip dynamometer score
|
Baseline to 12 weeks
|
|
Muscle power
Ramy czasowe: 12 weeks to 20 weeks
|
Change in hand grip dynamometer score
|
12 weeks to 20 weeks
|
|
Quality of Life - WHO-QOL BREF score
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 12 weeks
|
Number of times exercise diary completed
|
12 weeks
|
|
Dietary intake
Ramy czasowe: Baseline to 12 weeks
|
Change in Food Frequency Questionnaire score
|
Baseline to 12 weeks
|
|
Dietary intake
Ramy czasowe: 12 weeks to 20 weeks
|
Change in Food Frequency Questionnaire score
|
12 weeks to 20 weeks
|
|
Change in Medication
Ramy czasowe: Baseline to 12 weeks
|
Change in medication
|
Baseline to 12 weeks
|
|
Change in Medication
Ramy czasowe: 12 weeks to 20 weeks
|
Change in medication
|
12 weeks to 20 weeks
|
|
Glycaemic control
Ramy czasowe: 12 weeks to 20 weeks
|
Change in HbA1c
|
12 weeks to 20 weeks
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Dyrektor Studium: Lorna Paul, PhD, Glasgow Caledonian University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- GN17DI329
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Cukrzyca typu 2
-
Leiden University Medical CenterZakończonyGruczolak przysadki | Guz przysadki | Diabetes Insipidus Cranial Type | Dokrewny; NiedobórHolandia
-
Centre Hospitalier Universitaire de LiegeSanofi; Takeda; University of Liege; Orchard Therapeutics; Centre Hospitalier Régional... i inni współpracownicyRekrutacyjnyWrodzony przerost nadnerczy | Hemofilia A | Hemofilia B | Mukopolisacharydoza I | Mukopolisacharydoza II | Mukowiscydoza | Niedobór alfa 1-antytrypsyny | Anemia sierpowata | Anemia Fanconiego | Przewlekła choroba ziarniniakowa | Choroba Wilsona | Ciężka wrodzona neutropenia | Niedobór transkarbamylazy ornityny | Mukopolisacharydoza... i inne warunkiBelgia
-
UK Kidney AssociationRekrutacyjnyZapalenie naczyń | AL Amyloidoza | Stwardnienie guzowate | Choroba Fabry'ego | Cystynuria | Ogniskowe segmentowe stwardnienie kłębuszków nerkowych | Nefropatia IgA | Syndrom Barttera | Czysta aplazja czerwonokrwinkowa | Nefropatia błoniasta | Atypowy zespół hemolityczno-mocznicowy | Autosomalna dominująca policystyczna... i inne warunkiZjednoczone Królestwo
Badania kliniczne na Web-based exercise programme
-
Memorial Sloan Kettering Cancer CenterZakończonyRak prostatyStany Zjednoczone