Mobile Health to Enhance Exercise in Type 2 Diabetes (MOTIVATET2D)
26 de abril de 2021 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Antecipado)
120
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Ali McManus, PhD
- Número de telefone: 250-807-8192
- E-mail: ali.mcmanus@ubc.ca
Estude backup de contato
- Nome: Matthew S Cocks, PhD
- Número de telefone: 0151 904 6243
- E-mail: M.S.Cocks@ljmu.ac.uk
Locais de estudo
-
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British Columbia
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Kelowna, British Columbia, Canadá, V1V1V7
- Recrutamento
- University of British Columbia
-
Contato:
- Jonathan Low
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
40 anos a 75 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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).
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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
Outros nomes:
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Comparador Ativo: 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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Determine the number of adults with newly diagnosed T2D that are eligible to participate in the trial
Prazo: 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
Prazo: 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
Prazo: 0-12 months
|
Information will be collected on: - Patient gender, age, and how patients are currently treating their T2D |
0-12 months
|
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The number and percentage of participants retained at 12-months.
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Adherence to exercise
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 0 months, 0-6 months, 0-12 months
|
Weight (kilograms)
|
0 months, 0-6 months, 0-12 months
|
|
Change in waist circumference
Prazo: 0 months, 0-6 months, 0-12 months
|
Waist circumference (centimeters)
|
0 months, 0-6 months, 0-12 months
|
|
Change in blood pressure
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 0 months, 0-6 months, 0-12 months
|
Assessed using the Patient Rapport with Counsellor Questionnaire
|
0 months, 0-6 months, 0-12 months
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Acceptability and feasibility of the wearable intervention to patients
Prazo: 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
|
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Acceptability and feasibility of patients continuing the intervention on their own
Prazo: 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
Prazo: 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
Prazo: 0-12 months
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Post intervention patient questionnaire investigating the acceptability of the recruitment and randomisation process and the measurement instruments
|
0-12 months
|
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Determine availability and completeness of economic data
Prazo: 0 months, 0-6 months, 0-12 months
|
5-level EQ-5D Questionnaire
|
0 months, 0-6 months, 0-12 months
|
|
Determine healthcare usage
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de fevereiro de 2021
Conclusão Primária (Antecipado)
1 de dezembro de 2022
Conclusão do estudo (Antecipado)
1 de maio de 2023
Datas de inscrição no estudo
Enviado pela primeira vez
19 de novembro de 2020
Enviado pela primeira vez que atendeu aos critérios de CQ
26 de novembro de 2020
Primeira postagem (Real)
4 de dezembro de 2020
Atualizações de registro de estudo
Última Atualização Postada (Real)
28 de abril de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
26 de abril de 2021
Última verificação
1 de abril de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- H20-01936
- 20/SS/0101 (Outro identificador: South East Scotland Research Ethics Committee)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Prazo de Compartilhamento de IPD
Data will be stored in this repository for a minimum of 10 years or for 10 years from the last date of access.
Critérios de acesso de compartilhamento 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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