AMD-Life: Adherence to Lifestyle Changes for Age-related Macular Degeneration

Sponsor

Erasmus Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05667441

Collaborator

CORR foundation (Other)

150

Enrollment

Location

Arms

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Age-Related Macular Degeneration	Combination Product: Standard lifestyle recommendations + dietary supplementation Combination Product: Risk profiling Behavioral: Coaching	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Adherence to Lifestyle Changes for Age-related Macular Degeneration

Actual Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Combination Product: 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
Active Comparator: 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.	Combination Product: 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 Combination Product: Risk profiling Personalized risk profiling for lifestyle and genetics.
Active Comparator: 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.	Combination Product: 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 Combination Product: Risk profiling Personalized risk profiling for lifestyle and genetics. Behavioral: Coaching Coaching

Arm

Intervention/Treatment

Active Comparator: 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.

Combination Product: 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

Active Comparator: 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.

Combination Product: Standard lifestyle recommendations + dietary supplementation

Combination Product: Risk profiling

Personalized risk profiling for lifestyle and genetics.

Active Comparator: 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.

Combination Product: Standard lifestyle recommendations + dietary supplementation

Combination Product: Risk profiling

Personalized risk profiling for lifestyle and genetics.

Behavioral: Coaching

Coaching

Outcome Measures

Primary Outcome Measures

Change in lifestyle score [0 and 12 months: intervention phase]
Change in lifestyle as measured by online questionnaires, scale from 0-13 in which 13 represents a healthy lifestyle
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.