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Mobile Health to Enhance Exercise in Type 2 Diabetes (MOTIVATET2D)

26. april 2021 oppdatert av: Jonathan Little, University of British Columbia

Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Type 2 Diabetes: A Pilot Randomized Trial

Being physically active and exercising is important for the treatment of Type 2 diabetes as it helps control blood sugar and improve physical function. Lots of people find it hard to be physically active and sticking with exercise is difficult for most people. In this project we will investigate two strategies to support people with Type 2 diabetes to increase and then maintain a physically active lifestyle, which includes exercising regularly. Participants in one group (Exercise Counselling) will complete a 6-month structured exercise and physical activity programme supported by regular (virtual) contact with an exercise specialist. Participants in the second group (Mobile health technology (mHealth)) will receive the same 6-month exercise and physical activity programme supported by an exercise specialist, but participants in this group will also receive a fitness watch that links to a mobile phone application (App). The fitness watch and mobile App will allow the exercise specialist to provide greater support and feedback throughout the programme.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

120

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1V1V7
        • Rekruttering
        • University of British Columbia
        • Ta kontakt med:
          • Jonathan Low

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

40 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Diagnosed with T2D within the previous 5-24 months
  • Male or Female
  • Aged 40-75
  • Treat diabetes with only Metformin or lifestyle modifications (diet and exercise)
  • For those prescribed Metformin: have used a stable dose for 3-months or more

Exclusion Criteria:

  • Aged under 40 or over 75
  • Glycated hemoglobin level (HbA1c) more than 10% (>86mmol/mol)
  • Blood pressure higher than 160/110 mmHg
  • Treat diabetes with an antidiabetic drug other than Metformin (Sulfonylureas, Thiazolidinedione, dipeptidylpeptidase-4 inhibitors, sodium glucose co-transporter 2 inhibitors, glucagon-like peptide-1 receptor agonist, Acarbose, meglitinides)
  • Prescription of Insulin
  • Unstable angina (frequent chest pain)
  • Myocardial infarction (heart attack) within the previous 3 months
  • Transient ischemic attack (TIA) within the previous 6 months
  • Heart failure ≥class 2
  • Arrhythmia
  • Inability to increase activity
  • Pregnancy or planning to become pregnant
  • Less than 6 months post childbirth or stopped breastfeeding less than 1 month ago
  • Not owning a smartphone/ or having no data plan or access to WiFi
  • currently meeting the recommended exercise guidelines (150 min of moderate intensity exercise per week).

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: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: mHealth Technology
Participants in this group (Mobile health technology (mHealth)) will receive the same 6-month exercise and physical activity programme supported by an exercise specialist, but participants in this group will also receive a fitness watch that links to a mobile phone application (App).
Atferdsmessig: Exercise Programme and Counselling
A 6 month exercise and physical activity programme supported by an exercise specialist
Enhet: Polar Ignite and App
A fitness watch that links to a mobile phone application (App) which enables the exercise specialist to provide greater support and feedback throughout the programme
Andre navn:
  • Polar Watch
  • Polar Flow
Aktiv komparator: Exercise Counselling
Participants in this group (Exercise Counselling) will complete a 6-month structured exercise and physical activity programme supported by regular contact with an exercise specialist.
Atferdsmessig: Exercise Programme and Counselling
A 6 month exercise and physical activity programme supported by an exercise specialist

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Determine the number of adults with newly diagnosed T2D that are eligible to participate in the trial
Tidsramme: 0-12 months

Information will be collected on:

- The number of patients approached and reasons for not joining the study
0-12 months
The number of these adults with newly diagnosed T2D who would be willing to take part in this trial
Tidsramme: 0-12 months

Information will be collected on:

- The number of patients who actually enroll
0-12 months
The characteristics of these adults with newly diagnosed T2D who are willing to take part in the trial
Tidsramme: 0-12 months

Information will be collected on:

- Patient gender, age, and how patients are currently treating their T2D
0-12 months
The number and percentage of participants retained at 12-months.
Tidsramme: 0-12 months

Information will be collected on:

- Number and percentage of patients attending at 12-month follow up and reasons for drop-out.
0-12 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Adherence to exercise
Tidsramme: 0 months, 0-6 months, 0-12 months
Adherence to structured exercise assessed through monthly exercise questionnaire (GLTEQ)
0 months, 0-6 months, 0-12 months
Change in glycaemic control
Tidsramme: 0 months, 0-6 months, 0-12 months
Glycated hemoglobin (HbA1c), flash glucose monitoring
0 months, 0-6 months, 0-12 months
Change in body composition
Tidsramme: 0 months, 0-6 months, 0-12 months
Height (meters) and weight (kilograms) will be aggregated to arrive at one reported BMI value (kg/m^2)
0 months, 0-6 months, 0-12 months
Change in weight
Tidsramme: 0 months, 0-6 months, 0-12 months
Weight (kilograms)
0 months, 0-6 months, 0-12 months
Change in waist circumference
Tidsramme: 0 months, 0-6 months, 0-12 months
Waist circumference (centimeters)
0 months, 0-6 months, 0-12 months
Change in blood pressure
Tidsramme: 0 months, 0-6 months, 0-12 months
Blood pressure taken with a cuff
0 months, 0-6 months, 0-12 months
Change in blood lipids
Tidsramme: 0 months, 0-6 months, 0-12 months
Total cholesterol, high-density lipoprotein, triglycerides, low-density lipoprotein
0 months, 0-6 months, 0-12 months
Diabetes related quality of life
Tidsramme: 0 months, 0-6 months, 0-12 months
SF-12 Health Survey and Diabetes Treatment Satisfaction Questionnaire used to assess diabetes related quality of life
0 months, 0-6 months, 0-12 months
Behavioural regulation in exercise
Tidsramme: 0 months, 0-6 months, 0-12 months
Assessed using the Behavioural Regulation in Exercise Questionnaire
0 months, 0-6 months, 0-12 months
Patient rapport with counsellor
Tidsramme: 0 months, 0-6 months, 0-12 months
Assessed using the Patient Rapport with Counsellor Questionnaire
0 months, 0-6 months, 0-12 months

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Acceptability and feasibility of the wearable intervention to patients
Tidsramme: 0-6 months, 0-12 months
Post-intervention patient questionnaire that will assess the acceptability of the wearable intervention and exposure to other wearable technologies
0-6 months, 0-12 months
Acceptability and feasibility of patients continuing the intervention on their own
Tidsramme: 0-6 months, 0-12 months
Follow-up patient questionnaire investigating anticipated barriers and facilitators to continuing the intervention
0-6 months, 0-12 months
Pilot methods for collecting outcome measures
Tidsramme: Approx. 1 month after baseline
Early acceptability questionnaire investigating the acceptability of the measurement instruments and their ease of use.
Approx. 1 month after baseline
Ensure that our plans for recruitment, randomisation, treatment, and follow-up are acceptable to patients
Tidsramme: 0-12 months
Post intervention patient questionnaire investigating the acceptability of the recruitment and randomisation process and the measurement instruments
0-12 months
Determine availability and completeness of economic data
Tidsramme: 0 months, 0-6 months, 0-12 months
5-level EQ-5D Questionnaire
0 months, 0-6 months, 0-12 months
Determine healthcare usage
Tidsramme: 0 months, 0-6 months, 0-12 months
Questionnaire assessing healthcare usage in the last 12 weeks
0 months, 0-6 months, 0-12 months

Samarbeidspartnere og etterforskere

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

Sponsor

University of British Columbia

Samarbeidspartnere

Canadian Institutes of Health Research (CIHR)
Medical Research Council
Liverpool John Moores University
University of Exeter
Lancaster University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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)

1. februar 2021

Primær fullføring (Forventet)

1. desember 2022

Studiet fullført (Forventet)

1. mai 2023

Datoer for studieregistrering

Først innsendt

19. november 2020

Først innsendt som oppfylte QC-kriteriene

26. november 2020

Først lagt ut (Faktiske)

4. desember 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. april 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. april 2021

Sist bekreftet

1. april 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • H20-01936
  • 20/SS/0101 (Annen identifikator: South East Scotland Research Ethics Committee)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Pseudonymised data from this study will be made available for sharing with other investigators, after publication of the study's key papers. Data will be shared through the LJMU Data Repository (http://opendata.ljmu.ac.uk/). This is a secure institutional data repository, which is searchable on the www, it is managed by Library Services. A DOI will be generated for datasets as they are deposited to the repository. Data will be stored in this repository for a minimum of 10 years or for 10 years from the last date of access.

IPD-delingstidsramme

Data will be stored in this repository for a minimum of 10 years or for 10 years from the last date of access.

Tilgangskriterier for IPD-deling

Data will be shared through the LJMU Data Repository (http://opendata.ljmu.ac.uk/). This is a secure institutional data repository, which is searchable on the www, it is managed by Library Services. A DOI will be generated for datasets as they are deposited to the repository.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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