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

26 april 2021 uppdaterad 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Förväntat)

120

Fas

  • Inte tillämpbar

Kontakter och platser

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

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Kanada
    • British Columbia
      • Kelowna, British Columbia, Kanada, V1V1V7
        • Rekrytering
        • University of British Columbia
        • Kontakt:
          • Jonathan Low

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

40 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

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: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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).
Beteende: 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
Andra namn:
  • 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.
Beteende: Exercise Programme and Counselling
A 6 month exercise and physical activity programme supported by an exercise specialist

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Determine the number of adults with newly diagnosed T2D that are eligible to participate in the trial
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Adherence to exercise
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 0 months, 0-6 months, 0-12 months
Weight (kilograms)
0 months, 0-6 months, 0-12 months
Change in waist circumference
Tidsram: 0 months, 0-6 months, 0-12 months
Waist circumference (centimeters)
0 months, 0-6 months, 0-12 months
Change in blood pressure
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 0 months, 0-6 months, 0-12 months
Assessed using the Patient Rapport with Counsellor Questionnaire
0 months, 0-6 months, 0-12 months

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Acceptability and feasibility of the wearable intervention to patients
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 0 months, 0-6 months, 0-12 months
5-level EQ-5D Questionnaire
0 months, 0-6 months, 0-12 months
Determine healthcare usage
Tidsram: 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

Samarbetspartners och utredare

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

Sponsor

University of British Columbia

Samarbetspartners

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

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)

1 februari 2021

Primärt slutförande (Förväntat)

1 december 2022

Avslutad studie (Förväntat)

1 maj 2023

Studieregistreringsdatum

Först inskickad

19 november 2020

Först inskickad som uppfyllde QC-kriterierna

26 november 2020

Första postat (Faktisk)

4 december 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

28 april 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 april 2021

Senast verifierad

1 april 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

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

Kriterier för IPD Sharing Access

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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