Mobile Health to Enhance Exercise in Type 2 Diabetes (MOTIVATET2D)
26 avril 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Anticipé)
120
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Ali McManus, PhD
- Numéro de téléphone: 250-807-8192
- E-mail: ali.mcmanus@ubc.ca
Sauvegarde des contacts de l'étude
- Nom: Matthew S Cocks, PhD
- Numéro de téléphone: 0151 904 6243
- E-mail: M.S.Cocks@ljmu.ac.uk
Lieux d'étude
-
-
British Columbia
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Kelowna, British Columbia, Canada, V1V1V7
- Recrutement
- University of British Columbia
-
Contact:
- Jonathan Low
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
40 ans à 75 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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).
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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).
|
A 6 month exercise and physical activity programme supported by an exercise specialist
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
Autres noms:
|
|
Comparateur actif: 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.
|
A 6 month exercise and physical activity programme supported by an exercise specialist
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Determine the number of adults with newly diagnosed T2D that are eligible to participate in the trial
Délai: 0-12 months
|
Information will be collected on: - The number of patients approached and reasons for not joining the study |
0-12 months
|
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The number of these adults with newly diagnosed T2D who would be willing to take part in this trial
Délai: 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
Délai: 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.
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Adherence to exercise
Délai: 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
Délai: 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
Délai: 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
Délai: 0 months, 0-6 months, 0-12 months
|
Weight (kilograms)
|
0 months, 0-6 months, 0-12 months
|
|
Change in waist circumference
Délai: 0 months, 0-6 months, 0-12 months
|
Waist circumference (centimeters)
|
0 months, 0-6 months, 0-12 months
|
|
Change in blood pressure
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 0 months, 0-6 months, 0-12 months
|
Assessed using the Patient Rapport with Counsellor Questionnaire
|
0 months, 0-6 months, 0-12 months
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Acceptability and feasibility of the wearable intervention to patients
Délai: 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
Délai: 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
|
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Pilot methods for collecting outcome measures
Délai: 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
|
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Ensure that our plans for recruitment, randomisation, treatment, and follow-up are acceptable to patients
Délai: 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
Délai: 0 months, 0-6 months, 0-12 months
|
5-level EQ-5D Questionnaire
|
0 months, 0-6 months, 0-12 months
|
|
Determine healthcare usage
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 février 2021
Achèvement primaire (Anticipé)
1 décembre 2022
Achèvement de l'étude (Anticipé)
1 mai 2023
Dates d'inscription aux études
Première soumission
19 novembre 2020
Première soumission répondant aux critères de contrôle qualité
26 novembre 2020
Première publication (Réel)
4 décembre 2020
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
28 avril 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 avril 2021
Dernière vérification
1 avril 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- H20-01936
- 20/SS/0101 (Autre identifiant: South East Scotland Research Ethics Committee)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
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.
Délai de partage IPD
Data will be stored in this repository for a minimum of 10 years or for 10 years from the last date of access.
Critères d'accès au partage IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .