Adherence to Lifestyle Changes for Age-related Macular Degeneration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2025-07-14

Brief Summary

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The AMD-Life study investigates which strategies (personalized risk-profiling including genetic testing and/or coaching) motivate AMD patients to change their lifestyle.

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Detailed Description

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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.

Conditions

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Age-Related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open label, randomized, clinical trial with 3 arms. Total study duration 2 years: intervention period for 1 year and a follow-up period of 1 year with no intervention for all study arms.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard recommendations

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.

Group Type ACTIVE_COMPARATOR

Standard lifestyle recommendations + dietary supplementation

Intervention Type COMBINATION_PRODUCT

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

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.

Group Type ACTIVE_COMPARATOR

Standard lifestyle recommendations + dietary supplementation

Intervention Type COMBINATION_PRODUCT

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

Risk profiling

Intervention Type COMBINATION_PRODUCT

Personalized risk profiling for lifestyle and genetics.

Standard recommendations + Risk profiling + Additional 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.

Group Type ACTIVE_COMPARATOR

Standard lifestyle recommendations + dietary supplementation

Intervention Type COMBINATION_PRODUCT

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

Risk profiling

Intervention Type COMBINATION_PRODUCT

Personalized risk profiling for lifestyle and genetics.

Coaching

Intervention Type BEHAVIORAL

Coaching

Interventions

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Standard lifestyle recommendations + dietary supplementation

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

Intervention Type COMBINATION_PRODUCT

Risk profiling

Personalized risk profiling for lifestyle and genetics.

Intervention Type COMBINATION_PRODUCT

Coaching

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No