Adherence to Lifestyle Changes for Age-related Macular Degeneration
AMD-Life
2 other identifiers
interventional
150
1 country
1
Brief Summary
The AMD-Life study investigates which strategies (personalized risk-profiling including genetic testing and/or coaching) motivate AMD patients to change their lifestyle.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2021
CompletedFirst Submitted
Initial submission to the registry
November 21, 2022
CompletedFirst Posted
Study publicly available on registry
December 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 14, 2025
CompletedSeptember 11, 2025
September 1, 2025
4 years
November 21, 2022
September 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in lifestyle score
Change in lifestyle as measured by online questionnaires, scale from 0-13 in which 13 represents a healthy lifestyle
0 and 12 months: intervention phase
Change in lifestyle score
Change in lifestyle as measured by online questionnaires, scale from 0-13 in which 13 represents a healthy lifestyle
12 and 24 months: follow-up phase
Study Arms (3)
Standard recommendations
ACTIVE COMPARATORThe first group (n=50) will receive standard care recommendations (according to Netherlands Scientific Society of Ophthalmology 2014, 'Richtlijn Leeftijdsgebonden Maculadegeneratie;): refrain from smoking; perform physical exercise regularly; increase the intake of dietary food groups such as green leafy vegetables, fruits, and fatty fish; and recommendations for supplementation with antioxidants according an established formula.
Standard recommendations + Risk profiling
ACTIVE COMPARATORThe second group (n=50) receives standard care plus personalized risk profiling. A risk scoring based on currently available literature for lifestyle and genetic risk will be used to determine personalized risks of conversion to late AMD. Individuals will be informed about their own risk profile and a personalized strategy will be communicated.
Standard recommendations + Risk profiling + Additional coaching
ACTIVE COMPARATORThe third group (n=50) receives standard care (see 1); personalized risk profiling (see 2); and coaching. A coach will employ behavioral change techniques (BCT) to enhance adherence using motivational interviews, feedback on behavior; and focus on the advantages of following recommendations.
Interventions
refrain from smoking; perform physical exercise regularly; increase the intake of dietary food groups such as green leafy vegetables, fruits, and fatty fish and recommendations for supplementation with antioxidants according an established formula
Personalized risk profiling for lifestyle and genetics.
Eligibility Criteria
You may qualify if:
- Early/Intermediate AMD or unilateral late AMD with minimal vision 0.8
You may not qualify if:
- Participation in other intervention studies for AMD
- Living in retirement homes (difficulty in implementation of diet)
- Diagnosis of dementia (because of unreliable dietary recall)
- Persons with macular pathology other than AMD hindering appropriate grading of the macula
- Persons who are illiterate and have no independent trusted person with them to explain the informed consent form.
- Persons diagnosed with liver and kidney insufficiency.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Erasmus Medical Centerlead
- CORR foundationcollaborator
Study Sites (1)
Erasmus Medical Center
Rotterdam, Netherlands
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
C.C.W. Klaver, Prof. Dr.
Erasmus Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. dr. C.C.W. Klaver
Study Record Dates
First Submitted
November 21, 2022
First Posted
December 28, 2022
Study Start
August 1, 2021
Primary Completion
July 14, 2025
Study Completion
July 14, 2025
Last Updated
September 11, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share