Adherence to Lifestyle Changes for Age-related Macular Degeneration

Not Applicable

Active, not recruiting

• Conditions: Age-Related Macular Degeneration
• Interventions: Combination Product: Standard lifestyle recommendations + dietary supplementation; Combination Product: Risk profiling; Behavioral: Coaching

• Registration Number: NCT05667441
• Lead Sponsor: Erasmus Medical Center

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.

Detailed Description

Age-related macular degeneration is a frequent eye disease in the elderly affecting the center of retina, i.e., the macula. Despite current treatments for the wet form of this disease, it is still the most frequent cause of blindness in the Western world. The disease is the result of the interplay between genetic and environmental factors such as smoking, unhealthy diet, and lack of physical activity. The current clinical recommendations are aimed towards these lifestyle factors: a healthy diet, no smoking, regular physical exercise, and use of antioxidant supplementation. Although assumed to be low by clinicians as they feel patients find it difficult to actually alter their lifestyle, the adherence and feasibility to these recommendations in clinical ophthalmology practice is unclear. Individualizing the patients' risk of blindness and lifestyle changes, as well as coaching may positively influence adherence strategies. This pilot study aims to gain knowledge and experience in a relatively small study comparing adherence to these strategies through a healthier lifestyle. Additionally, the trial investigates blood and gut microbiome biomarkers: which molecules in blood directly relate to the supplemented nutrients as well as those related to the pathogenesis of AMD, and which biomarkers in blood and eye best correlate with supplement intake and lifestyle.

Study Timeline

• Study Start: 2021-08-01
• Study First Submitted: 2022-11-21
• Study First Submitted QC: 2022-12-19
• Study First Posted: 2022-12-28
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-20
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Early/Intermediate AMD or unilateral late AMD with minimal vision 0.8

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard recommendations + Risk profiling + Additional coaching	Coaching	The 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.
Standard recommendations + Risk profiling	Standard lifestyle recommendations + dietary supplementation	The 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	Risk profiling	The 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	Standard lifestyle recommendations + dietary supplementation	The 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 + Additional coaching	Standard lifestyle recommendations + dietary supplementation	The 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.
Standard recommendations + Risk profiling + Additional coaching	Risk profiling	The 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.

Primary Outcome Measures

Name	Time	Method
Change in lifestyle score	12 and 24 months: follow-up phase	Change in lifestyle as measured by online questionnaires, scale from 0-13 in which 13 represents a healthy lifestyle

Trial Locations

Locations (1)

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands