2.1. Study Design and Population
Erasmus, AMD, dementia, liver and kidney insufficiency
PATHOLOGY, EYE
AMD-Life is a 2-year lifestyle intervention trial. The first year is a self-contained open-label randomized clinical trial with 3 intervention arms. The second year aims to investigate the sustainability of improved lifestyle without active intervention. Patients visit the research center 3 times: at baseline, month 12, and month 24. Ethical approval was obtained from the Medical Ethical Committee at Erasmus MC (MEC-2018-063). AMD-Life is registered at ClinicalTrials.gov (registration identifier: NCT05667441).This study is designed as an inception phase study. We set up the main elements, test our assumptions and feasibility, check procedures, and focus on adherence, reporting participant and physician experience for the three different strategies tested, specifically targeting long-term behavior change.Sample size calculation indicated that 50 eligible subjects per group would be sufficient to detect an effect size of 0.25 for adherence to lifestyle recommendations after the 12-month intervention (alpha: 0.05, power: (1-beta err prob.): 0.8897, calculated by G*Power).Recruitment for the study started 2 August 2021 and is expected to end 1 July 2023. Participants are made aware of the study by their attending physician at outpatient clinics (OPC) of Erasmus MC Rotterdam, the Rotterdam Eye Hospital, Radboudumc, in Nijmegen, and other hospitals in the Netherlands. Interested candidates can apply online through the website: Inclusion criteria: age between 55 years and 85 years, a diagnosis of intermediate AMD or unilateral late AMD, as determined by multimodal imaging and approved by the EyeNED Reading Center.Exclusion criteria: participation in other intervention studies for AMD; living in retirement homes (because of difficulty in implementation of diet); dementia; macular pathology other than AMD; liver and kidney insufficiency; persons who are illiterate and have no independent trusted person with them to explain the informed consent form.Prior to the study, all potential participants are informed and asked to provide written consent. Subsequently, participants are invited to visit the research center. Eligible participants are randomly assigned using a block-wise randomization procedure (in a 1:1:1 ratio) to one of three study arms. The assignment is by means of a computer-generated table with a random number sequence. This table gives a random order of allocation to the ‘Treatment Group’. The order is by date and time of the first study visit and stratified by gender and age categories (55–64, 65–74, 75–85). The first 125 participants are randomized per block (sets) of 6, and the remaining 25 per sets of 3. The researchers are blinded for randomization.