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Article

Recruitment and Baseline Characteristics of Participants in the AgeWell.de Study—A Pragmatic Cluster-Randomized Controlled Lifestyle Trial against Cognitive Decline

1
Institute of Social Medicine, Occupational Health and Public Health (ISAP), Medical Faculty, University of Leipzig, 04103 Leipzig, Germany
2
Global Brain Health Institute (GBHI), Trinity College Dublin, D02 PN40 Dublin, Ireland
3
Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, 20246 Hamburg, Germany
4
Department of Clinical Pharmacology and Pharmacoepidemiology, University Hospital Heidelberg, 69120 Heidelberg, Germany
5
Institute of General Practice/Family Medicine, University Hospital of LMU Munich, 80336 Munich, Germany
6
Institute of General Practice and Family Medicine, Martin-Luther-University Halle-Wittenberg, 06112 Halle (Saale), Germany
7
Institute of General Practice, University of Kiel, 24105 Kiel, Germany
8
Institute for General Practice, Work Group Medical Statistics and IT-Infrastructure, Hannover Medical School, 30625 Hannover, Germany
9
Institute for Community Medicine, University Medicine Greifswald, 17489 Greifswald, Germany
10
German Center for Neurodegenerative Diseases (DZNE), Site Rostock/Greifswald, 17489 Greifswald, Germany
*
Author to whom correspondence should be addressed.
These two authors contributed equally.
Int. J. Environ. Res. Public Health 2021, 18(2), 408; https://doi.org/10.3390/ijerph18020408
Received: 25 November 2020 / Revised: 2 January 2021 / Accepted: 5 January 2021 / Published: 7 January 2021
(This article belongs to the Collection Aging and Public Health)
Targeting dementia prevention, first trials addressing multiple modifiable risk factors showed promising results in at-risk populations. In Germany, AgeWell.de is the first large-scale initiative investigating the effectiveness of a multi-component lifestyle intervention against cognitive decline. We aimed to investigate the recruitment process and baseline characteristics of the AgeWell.de participants to gain an understanding of the at-risk population and who engages in the intervention. General practitioners across five study sites recruited participants (aged 60–77 years, Cardiovascular Risk Factors, Aging, and Incidence of Dementia/CAIDE dementia risk score ≥ 9). Structured face-to-face interviews were conducted with eligible participants, including neuropsychological assessments. We analyzed group differences between (1) eligible vs. non-eligible participants, (2) participants vs. non-participants, and (3) between intervention groups. Of 1176 eligible participants, 146 (12.5%) dropped out before baseline; the study population was thus 1030 individuals. Non-participants did not differ from participants in key sociodemographic factors and dementia risk. Study participants were M = 69.0 (SD = 4.9) years old, and 52.1% were women. The average Montreal Cognitive Assessment/MoCA score was 24.5 (SD = 3.1), indicating a rather mildly cognitively impaired study population; however, 39.4% scored ≥ 26, thus being cognitively unimpaired. The bandwidth of cognitive states bears the interesting potential for differential trial outcome analyses. However, trial conduction is impacted by the COVID-19 pandemic, requiring adjustments to the study protocol with yet unclear methodological consequences. View Full-Text
Keywords: AgeWell.de; dementia; cognitive function; prevention; intervention; lifestyle; trial; RCT; cluster-randomized controlled trial; primary care; general practitioner AgeWell.de; dementia; cognitive function; prevention; intervention; lifestyle; trial; RCT; cluster-randomized controlled trial; primary care; general practitioner
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MDPI and ACS Style

Röhr, S.; Zülke, A.; Luppa, M.; Brettschneider, C.; Weißenborn, M.; Kühne, F.; Zöllinger, I.; Samos, F.-A.Z.; Bauer, A.; Döhring, J.; Krebs-Hein, K.; Oey, A.; Czock, D.; Frese, T.; Gensichen, J.; Haefeli, W.E.; Hoffmann, W.; Kaduszkiewicz, H.; König, H.-H.; Thyrian, J.R.; Wiese, B.; Riedel-Heller, S.G. Recruitment and Baseline Characteristics of Participants in the AgeWell.de Study—A Pragmatic Cluster-Randomized Controlled Lifestyle Trial against Cognitive Decline. Int. J. Environ. Res. Public Health 2021, 18, 408. https://doi.org/10.3390/ijerph18020408

AMA Style

Röhr S, Zülke A, Luppa M, Brettschneider C, Weißenborn M, Kühne F, Zöllinger I, Samos F-AZ, Bauer A, Döhring J, Krebs-Hein K, Oey A, Czock D, Frese T, Gensichen J, Haefeli WE, Hoffmann W, Kaduszkiewicz H, König H-H, Thyrian JR, Wiese B, Riedel-Heller SG. Recruitment and Baseline Characteristics of Participants in the AgeWell.de Study—A Pragmatic Cluster-Randomized Controlled Lifestyle Trial against Cognitive Decline. International Journal of Environmental Research and Public Health. 2021; 18(2):408. https://doi.org/10.3390/ijerph18020408

Chicago/Turabian Style

Röhr, Susanne, Andrea Zülke, Melanie Luppa, Christian Brettschneider, Marina Weißenborn, Flora Kühne, Isabel Zöllinger, Franziska-Antonia Z. Samos, Alexander Bauer, Juliane Döhring, Kerstin Krebs-Hein, Anke Oey, David Czock, Thomas Frese, Jochen Gensichen, Walter E. Haefeli, Wolfgang Hoffmann, Hanna Kaduszkiewicz, Hans-Helmut König, Jochen R. Thyrian, Birgitt Wiese, and Steffi G. Riedel-Heller 2021. "Recruitment and Baseline Characteristics of Participants in the AgeWell.de Study—A Pragmatic Cluster-Randomized Controlled Lifestyle Trial against Cognitive Decline" International Journal of Environmental Research and Public Health 18, no. 2: 408. https://doi.org/10.3390/ijerph18020408

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