Mobile Health to Enhance Exercise in Type 2 Diabetes (MOTIVATET2D)
26 de abril de 2021 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
120
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Ali McManus, PhD
- Número de teléfono: 250-807-8192
- Correo electrónico: ali.mcmanus@ubc.ca
Copia de seguridad de contactos de estudio
- Nombre: Matthew S Cocks, PhD
- Número de teléfono: 0151 904 6243
- Correo electrónico: M.S.Cocks@ljmu.ac.uk
Ubicaciones de estudio
-
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British Columbia
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Kelowna, British Columbia, Canadá, V1V1V7
- Reclutamiento
- University of British Columbia
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Contacto:
- Jonathan Low
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
40 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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
Otros nombres:
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Comparador activo: 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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Determine the number of adults with newly diagnosed T2D that are eligible to participate in the trial
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Adherence to exercise
Periodo de tiempo: 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
Periodo de tiempo: 0 months, 0-6 months, 0-12 months
|
Glycated hemoglobin (HbA1c), flash glucose monitoring
|
0 months, 0-6 months, 0-12 months
|
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Change in body composition
Periodo de tiempo: 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)
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0 months, 0-6 months, 0-12 months
|
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Change in weight
Periodo de tiempo: 0 months, 0-6 months, 0-12 months
|
Weight (kilograms)
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0 months, 0-6 months, 0-12 months
|
|
Change in waist circumference
Periodo de tiempo: 0 months, 0-6 months, 0-12 months
|
Waist circumference (centimeters)
|
0 months, 0-6 months, 0-12 months
|
|
Change in blood pressure
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Diabetes related quality of life
Periodo de tiempo: 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
|
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Behavioural regulation in exercise
Periodo de tiempo: 0 months, 0-6 months, 0-12 months
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Assessed using the Behavioural Regulation in Exercise Questionnaire
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0 months, 0-6 months, 0-12 months
|
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Patient rapport with counsellor
Periodo de tiempo: 0 months, 0-6 months, 0-12 months
|
Assessed using the Patient Rapport with Counsellor Questionnaire
|
0 months, 0-6 months, 0-12 months
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Acceptability and feasibility of the wearable intervention to patients
Periodo de tiempo: 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
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0-6 months, 0-12 months
|
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Acceptability and feasibility of patients continuing the intervention on their own
Periodo de tiempo: 0-6 months, 0-12 months
|
Follow-up patient questionnaire investigating anticipated barriers and facilitators to continuing the intervention
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0-6 months, 0-12 months
|
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Pilot methods for collecting outcome measures
Periodo de tiempo: Approx. 1 month after baseline
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Early acceptability questionnaire investigating the acceptability of the measurement instruments and their ease of use.
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Approx. 1 month after baseline
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Ensure that our plans for recruitment, randomisation, treatment, and follow-up are acceptable to patients
Periodo de tiempo: 0-12 months
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Post intervention patient questionnaire investigating the acceptability of the recruitment and randomisation process and the measurement instruments
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0-12 months
|
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Determine availability and completeness of economic data
Periodo de tiempo: 0 months, 0-6 months, 0-12 months
|
5-level EQ-5D Questionnaire
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0 months, 0-6 months, 0-12 months
|
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Determine healthcare usage
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de febrero de 2021
Finalización primaria (Anticipado)
1 de diciembre de 2022
Finalización del estudio (Anticipado)
1 de mayo de 2023
Fechas de registro del estudio
Enviado por primera vez
19 de noviembre de 2020
Primero enviado que cumplió con los criterios de control de calidad
26 de noviembre de 2020
Publicado por primera vez (Actual)
4 de diciembre de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de abril de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
26 de abril de 2021
Última verificación
1 de abril de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- H20-01936
- 20/SS/0101 (Otro identificador: South East Scotland Research Ethics Committee)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Marco de tiempo para compartir IPD
Data will be stored in this repository for a minimum of 10 years or for 10 years from the last date of access.
Criterios de acceso compartido de 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Diabetes Mellitus, Tipo 2
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Instituto Nacional de Ciencias Medicas y Nutricion...Activo, no reclutando
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He Eye HospitalAún no reclutando
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Diabetes Solutions InternationalDexCom, Inc.; Tidepool; MAVEN ProjectReclutamientoDiabetes mellitus tipo 2 (DM2)Estados Unidos
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Ohio State UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Aún no reclutandoDM2 (Diabetes Mellitus Tipo 2)Estados Unidos
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Global Institute of Stem Cell Therapy and ResearchAún no reclutando
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San Diego State UniversityUniversity of California, Berkeley; National Institute on Minority Health and...ReclutamientoDiabetes mellitus | Diabetes | Diabetes mellitus tipo 2 | Diabetes mellitus tipo 2 (DM2)Estados Unidos