mHealth Intervention for Dementia Prevention through lifestyle Optimisation (MIND-PRO) in a primary care setting: protocol for a randomised controlled trial in people with low SES and/or migration background
Introduction The Mobile Health (mHealth) Intervention for Dementia Prevention through lifestyle Optimisation (MIND-PRO) study addresses the increasing prevalence of dementia among populations with lower socio-economic status (SES) and/or a migration background. The study aims to evaluate the effecti...
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BMJ Publishing Group
2025-02-01
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author | Edo Richard Esther Van den Berg Ron Handels Henrike Galenkamp Eric P Moll van Charante Marieke P Hoevenaar-blom Anne Roos van der Endt Martien J H Kas |
author_facet | Edo Richard Esther Van den Berg Ron Handels Henrike Galenkamp Eric P Moll van Charante Marieke P Hoevenaar-blom Anne Roos van der Endt Martien J H Kas |
author_sort | Edo Richard |
collection | DOAJ |
description | Introduction The Mobile Health (mHealth) Intervention for Dementia Prevention through lifestyle Optimisation (MIND-PRO) study addresses the increasing prevalence of dementia among populations with lower socio-economic status (SES) and/or a migration background. The study aims to evaluate the effectiveness and implementation of an mHealth intervention designed for self-managing lifestyle modifications with remote coaching to reduce dementia risk factors.Methods and analysis This prospective randomised open-label blinded end point (PROBE) trial follows a type 2 hybrid effectiveness-implementation design with a 12-month intervention period. It aims to recruit 692 participants in Dutch primary care. Entry criteria include age 50–75 years, low SES and/or migration background, one or more dementia risk factors (hypertension, dyslipidaemia, diabetes mellitus, physical inactivity, smoking, depression and overweight) or manifest cardiovascular disease and possession of a smartphone. Participants are randomised to a coach-supported, interactive app facilitating self-management of dementia risk factors or to a control app with static health information. The primary effectiveness outcome is a composite score of systolic blood pressure, non-high-density lipoprotein cholesterol and body mass index. Implementation outcomes include coverage, adoption, acceptability, appropriateness, feasibility, fidelity, costs and sustainability of the intervention. Secondary outcomes include the Cardiovascular Risk Factors, Ageing and Dementia risk score and its individual risk factors, and disability, physical activity, depressive symptoms, cognitive functioning and daily distance moved.Ethics and dissemination The MIND-PRO trial is funded by the Netherlands Organisation for Health Research and Development (ZonMw, grant number 10510032120004) and approved by the Ethics Committee of Amsterdam UMC (reference: METC 2023.0770). Results are expected in 2026 and will be submitted for publication in a peer-reviewed journal, and presented at scientific conferences.Trial registration number ISRCTN92928122. |
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institution | Kabale University |
issn | 2044-6055 |
language | English |
publishDate | 2025-02-01 |
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spelling | doaj-art-0b27cb71cd50461c9398646ab78a1e142025-02-04T04:40:10ZengBMJ Publishing GroupBMJ Open2044-60552025-02-0115210.1136/bmjopen-2024-088324mHealth Intervention for Dementia Prevention through lifestyle Optimisation (MIND-PRO) in a primary care setting: protocol for a randomised controlled trial in people with low SES and/or migration backgroundEdo Richard0Esther Van den Berg1Ron Handels2Henrike Galenkamp3Eric P Moll van Charante4Marieke P Hoevenaar-blom5Anne Roos van der Endt6Martien J H Kas71 Department of Public and Occupational Health, Amsterdam UMC Location VUmc, Amsterdam, The Netherlands5 Department of Neurology and Alzheimer Center, Erasmus MC, Rotterdam, The Netherlands6 Alzheimer Centre Limburg, Department of Psychiatry and Neuropsychology, School of Mental Health and Neurosicences, Maastricht University, Maastricht, The Netherlands1 Department of Public and Occupational Health, Amsterdam UMC Location VUmc, Amsterdam, The Netherlands1 Department of Public and Occupational Health, Amsterdam UMC Location VUmc, Amsterdam, The Netherlands1 Department of Public and Occupational Health, Amsterdam UMC Location VUmc, Amsterdam, The Netherlands1 Department of Public and Occupational Health, Amsterdam UMC Location VUmc, Amsterdam, The Netherlands4 Institute for Evolutionary Life Sciences, University of Groningen, Groningen, The NetherlandsIntroduction The Mobile Health (mHealth) Intervention for Dementia Prevention through lifestyle Optimisation (MIND-PRO) study addresses the increasing prevalence of dementia among populations with lower socio-economic status (SES) and/or a migration background. The study aims to evaluate the effectiveness and implementation of an mHealth intervention designed for self-managing lifestyle modifications with remote coaching to reduce dementia risk factors.Methods and analysis This prospective randomised open-label blinded end point (PROBE) trial follows a type 2 hybrid effectiveness-implementation design with a 12-month intervention period. It aims to recruit 692 participants in Dutch primary care. Entry criteria include age 50–75 years, low SES and/or migration background, one or more dementia risk factors (hypertension, dyslipidaemia, diabetes mellitus, physical inactivity, smoking, depression and overweight) or manifest cardiovascular disease and possession of a smartphone. Participants are randomised to a coach-supported, interactive app facilitating self-management of dementia risk factors or to a control app with static health information. The primary effectiveness outcome is a composite score of systolic blood pressure, non-high-density lipoprotein cholesterol and body mass index. Implementation outcomes include coverage, adoption, acceptability, appropriateness, feasibility, fidelity, costs and sustainability of the intervention. Secondary outcomes include the Cardiovascular Risk Factors, Ageing and Dementia risk score and its individual risk factors, and disability, physical activity, depressive symptoms, cognitive functioning and daily distance moved.Ethics and dissemination The MIND-PRO trial is funded by the Netherlands Organisation for Health Research and Development (ZonMw, grant number 10510032120004) and approved by the Ethics Committee of Amsterdam UMC (reference: METC 2023.0770). Results are expected in 2026 and will be submitted for publication in a peer-reviewed journal, and presented at scientific conferences.Trial registration number ISRCTN92928122.https://bmjopen.bmj.com/content/15/2/e088324.full |
spellingShingle | Edo Richard Esther Van den Berg Ron Handels Henrike Galenkamp Eric P Moll van Charante Marieke P Hoevenaar-blom Anne Roos van der Endt Martien J H Kas mHealth Intervention for Dementia Prevention through lifestyle Optimisation (MIND-PRO) in a primary care setting: protocol for a randomised controlled trial in people with low SES and/or migration background BMJ Open |
title | mHealth Intervention for Dementia Prevention through lifestyle Optimisation (MIND-PRO) in a primary care setting: protocol for a randomised controlled trial in people with low SES and/or migration background |
title_full | mHealth Intervention for Dementia Prevention through lifestyle Optimisation (MIND-PRO) in a primary care setting: protocol for a randomised controlled trial in people with low SES and/or migration background |
title_fullStr | mHealth Intervention for Dementia Prevention through lifestyle Optimisation (MIND-PRO) in a primary care setting: protocol for a randomised controlled trial in people with low SES and/or migration background |
title_full_unstemmed | mHealth Intervention for Dementia Prevention through lifestyle Optimisation (MIND-PRO) in a primary care setting: protocol for a randomised controlled trial in people with low SES and/or migration background |
title_short | mHealth Intervention for Dementia Prevention through lifestyle Optimisation (MIND-PRO) in a primary care setting: protocol for a randomised controlled trial in people with low SES and/or migration background |
title_sort | mhealth intervention for dementia prevention through lifestyle optimisation mind pro in a primary care setting protocol for a randomised controlled trial in people with low ses and or migration background |
url | https://bmjopen.bmj.com/content/15/2/e088324.full |
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