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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Main Authors: 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
Format: Article
Language:English
Published: BMJ Publishing Group 2025-02-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/15/2/e088324.full
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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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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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