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Dietary intervention in patients with age-related macular degeneration: protocol for a randomised controlled trial
  1. Diana Tang1,
  2. Paul Mitchell1,
  3. Victoria Flood2,3,
  4. Annette Kifley1,
  5. Alison Hayes4,
  6. Gerald Liew1,
  7. Bamini Gopinath1
  1. 1 Centre for Vision Research, Department of Ophthalmology and Westmead Institute for Medical Research, University of Sydney, Sydney, New South Wales, Australia
  2. 2 Western Sydney Local Health District, Westmead Hospital, Westmead, New South Wales, Australia
  3. 3 Faculty of Health Sciences, Charles Perkins Centre, The University of Sydney, Sydney, New South Wales, Australia
  4. 4 Faculty of Medicine and Health, Sydney School of Public Health, The University of Sydney, Sydney, New South Wales, Australia
  1. Correspondence to Dr Bamini Gopinath; bamini.gopinath{at}sydney.edu.au

Abstract

Introduction Age-related macular degeneration (AMD) is a leading cause of blindness. After smoking, nutrition is the key modifiable factor in reducing AMD incidence and progression, and no other preventative treatments are currently available. At present, there is an evidence–practice gap of dietary recommendations made by eye care practitioners and those actually practised by patients with AMD. To address this gap, a telephone-delivered dietary intervention tailored to patients with AMD will be piloted. The study aims to improve dietary intake and behaviours in patients with AMD. This type of nutrition-focused healthcare is currently not considered in the long-term management of AMD and represents the first empirical evaluation of a telephone-supported application encouraging adherence to dietary recommendations for AMD.

Methods and analysis 140 participants with AMD will be recruited for this randomised controlled trial. Those lacking English fluency; unwilling to engage in the intervention or provide informed consent were excluded. Following the completion of the baseline questionnaire, participants will be randomised into one of two arms: intervention or wait-list control (70 each in the intervention and control groups). Intervention participants will receive a detailed mail-delivered workbook containing information on healthy eating behaviours that promote optimal macular health, as well as scheduled phone calls over 4 months from an accredited practising dietitian. Descriptive statistics and multivariate stepwise linear regressions analyses will be used to summarise and determine the changes in dietary intakes, respectively. Economic analysis will be conducted to determine intervention feasibility and possibility of a large-scale rollout.

Ethics and dissemination The study was approved by the University of Sydney Human Research Ethics Committee (HREC) (Reference: HREC 2018/219). Study findings will be disseminated via presentations at national/international conferences and peer-reviewed journal articles.

Trial registration number ACTRN12618000527268; Pre-results.

  • age-related macular degeneration
  • nutrition
  • telephone coaching
  • behaviour change
  • eye disease

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors Author responsibilities were as follows: study concept and design - BG, VF, PM, GL; data collection - DT; and drafting of manuscript - DT, BG, VF, AK, AH, GL, PM. The final version has been approved by all authors.

  • Funding This work is supported by National Health and Medical Research Council (NHMRC) grant number APP1150101.

  • Competing interests None declared.

  • Patient consent Obtained.

  • Ethics approval The University of Sydney Human Research Ethics Committee (HREC) has approved this study (reference: HREC 2018/2019).

  • Provenance and peer review Not commissioned; externally peer reviewed.

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