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      Uptake and effectiveness of a tailor-made online lifestyle programme targeting modifiable risk factors for dementia among middle-aged descendants of people with recently diagnosed dementia: study protocol of a cluster randomised controlled trial (Demin study)

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          Abstract

          Introduction

          Descendants of patients with dementia have a higher risk to develop dementia. This study aims to investigate the uptake and effectiveness of an online tailor-made lifestyle programme for dementia risk reduction (DRR) among middle-aged descendants of people with recently diagnosed late-onset dementia.

          Methods and analysis

          Demin is a cluster randomised controlled trial, aiming to include 21 memory clinics of which 13 will be randomly allocated to the passive (poster and flyer in a waiting room) and 8 to the active recruitment strategy (additional personal invitation by members of the team of the memory clinic). We aim to recruit 378 participants (40–60 years) with a parent who is recently diagnosed with Alzheimer’s disease or vascular dementia at one of the participating memory clinics. All participants receive a dementia risk assessment (online questionnaire, physical examination and blood sample) and subsequently an online tailor-made lifestyle advice regarding protective (Mediterranean diet, low/moderate alcohol consumption and high cognitive activity) and risk factors (physical inactivity, smoking, loneliness, cardiovascular diseases (CVD), hypertension, high cholesterol, diabetes, obesity, renal dysfunction and depression) for dementia. The primary outcome is the difference in uptake between the two recruitment strategies. Secondary outcomes are change(s) in (1) the Lifestyle for Brain Health score, (2) individual health behaviours, (3) health beliefs and attitudes towards DRR and (4) compliance to the tailor-made lifestyle advice. Outcomes will be measured at 3, 6, 9 and 12 months after baseline. The effectiveness of this online tailor-made lifestyle programme will be evaluated by comparing Demin participants to a matched control group (lifelines cohort).

          Ethics and dissemination

          This study has been approved by the Dutch Ministry of Health, Welfare and Sport according to the Population Screening Act. All participants have to give online informed consent using SMS-tan (transaction authentication number delivered via text message). Findings will be disseminated through peer-reviewed journals and (inter)national conferences.

          Trial registration number

          NTR7434.

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          Most cited references61

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          Guidelines for the Process of Cross-Cultural Adaptation of Self-Report Measures

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            Social cognitive theory: an agentic perspective.

            The capacity to exercise control over the nature and quality of one's life is the essence of humanness. Human agency is characterized by a number of core features that operate through phenomenal and functional consciousness. These include the temporal extension of agency through intentionality and forethought, self-regulation by self-reactive influence, and self-reflectiveness about one's capabilities, quality of functioning, and the meaning and purpose of one's life pursuits. Personal agency operates within a broad network of sociostructural influences. In these agentic transactions, people are producers as well as products of social systems. Social cognitive theory distinguishes among three modes of agency: direct personal agency, proxy agency that relies on others to act on one's behest to secure desired outcomes, and collective agency exercised through socially coordinative and interdependent effort. Growing transnational embeddedness and interdependence are placing a premium on collective efficacy to exercise control over personal destinies and national life.
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              Toward defining the preclinical stages of Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease.

              The pathophysiological process of Alzheimer's disease (AD) is thought to begin many years before the diagnosis of AD dementia. This long "preclinical" phase of AD would provide a critical opportunity for therapeutic intervention; however, we need to further elucidate the link between the pathological cascade of AD and the emergence of clinical symptoms. The National Institute on Aging and the Alzheimer's Association convened an international workgroup to review the biomarker, epidemiological, and neuropsychological evidence, and to develop recommendations to determine the factors which best predict the risk of progression from "normal" cognition to mild cognitive impairment and AD dementia. We propose a conceptual framework and operational research criteria, based on the prevailing scientific evidence to date, to test and refine these models with longitudinal clinical research studies. These recommendations are solely intended for research purposes and do not have any clinical implications at this time. It is hoped that these recommendations will provide a common rubric to advance the study of preclinical AD, and ultimately, aid the field in moving toward earlier intervention at a stage of AD when some disease-modifying therapies may be most efficacious. Copyright © 2011. Published by Elsevier Inc.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2020
                16 October 2020
                : 10
                : 10
                : e039439
                Affiliations
                [1 ]departmentDepartment of Epidemiology , University of Groningen, University Medical Centre Groningen , Groningen, The Netherlands
                [2 ]departmentDepartment of Medical Informatics , University of Amsterdam, Amsterdam UMC , Amsterdam, The Netherlands
                [3 ]departmentWenckebach Institute for Training and Education , University of Groningen, University Medical Centre Groningen , Groningen, The Netherlands
                [4 ]departmentDepartment of Neurology and Alzheimer Centre Groningen , University of Groningen, University Medical Centre Groningen , Groningen, The Netherlands
                [5 ]departmentDepartment of Health Sciences , University of Groningen, University Medical Centre Groningen , Groningen, The Netherlands
                [6 ]departmentDepartment of Psychiatry , University of Groningen, University Medical Centre Groningen , Groningen, The Netherlands
                [7 ]departmentMedical School Twente , Medical Spectrum Twente , Enschede, The Netherlands
                Author notes
                [Correspondence to ] Joyce Vrijsen; j.vrijsen@ 123456umcg.nl
                Author information
                http://orcid.org/0000-0003-1506-2266
                Article
                bmjopen-2020-039439
                10.1136/bmjopen-2020-039439
                7569992
                33067294
                0cf5e578-dd87-4748-8b3e-1dd38bc1e109
                © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See:  https://creativecommons.org/licenses/by/4.0/.

                History
                : 15 April 2020
                : 09 September 2020
                : 10 September 2020
                Categories
                Public Health
                1506
                1724
                Protocol
                Custom metadata
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                Medicine
                dementia,risk management,epidemiology,preventive medicine,public health
                Medicine
                dementia, risk management, epidemiology, preventive medicine, public health

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