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Dietary intervention for age-related macular degeneration patients

Implementing and evaluating a telephone-delivered dietary intervention for age-related macular degeneration patients

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000527268
Enrollment
155
Registered
2018-04-10
Start date
2018-06-12
Completion date
2019-07-02
Last updated
2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Age-related macular degeneration (AMD) is the principal cause of blindness in Australia. Therefore, all options to slow down the rate of development and progression of AMD are critical. After smoking, nutrition is the key modifiable risk factor to reduce AMD incidence and no other preventative treatments are currently available. Despite the strong evidence-base, there remains confusion among patients and practitioners about what foods should be consumed in order to maximise absorption of useful nutrients and what supplements to take. An intervention aiming to promote a diet that is regularly rich in vegetables, fruits, and fish, will ensure good macula health. Also, the intervention should appropriately advise on supplementation in the absence of sufficient dietary intake of long-chain omega-3 fats and key micronutrients (lutein/zeaxanthin, zinc, vitamins C and E). However, translation efforts in AMD have so far focused on screening and drug or laser treatments. Therefore, the proposed study will address this evidence-practice gap, by implementing and evaluating a telephone-delivered dietary behaviour intervention targeting patients with AMD. An economic assessment to measure the cost-effectiveness of the intervention will be undertaken. 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 telehealth application encouraging adherence to dietary recommendations for AMD. Further, wide-scale delivery of this intervention has potential to lower the risk of progression to blinding, late-stage AMD in high risk patients.

Interventions

This two-year project will implement and evaluate a telephone-delivered dietary behaviour intervention for AMD patients, aiming to promote a diet that is rich in vegetables, fruits, fish, low-glycaemic index foods and the appropriate use of antioxidant supplements. It will have a two-pronged approach: (1) ensures the correct information on diet and AMD is passed onto the patient; and (2) an accredited practicing dietitian (APD) provides telephone coaching and support to facilitate and enhance th

This two-year project will implement and evaluate a telephone-delivered dietary behaviour intervention for AMD patients, aiming to promote a diet that is rich in vegetables, fruits, fish, low-glycaemic index foods and the appropriate use of antioxidant supplements. It will have a two-pronged approach: (1) ensures the correct information on diet and AMD is passed onto the patient; and (2) an accredited practicing dietitian (APD) provides telephone coaching and support to facilitate and enhance the patients’ adoption of dietary recommendations. Participants will be randomised to one of two groups - intervention or wait-list control Participants in the intervention group will be mailed a workbook that contains information on dietary behaviours promoting optimal macula health; information on goal setting; problem-solving; self-rewards; positive self-talk; relapse, and action plans. They will be scheduled to receive weekly phone calls over 4 months from the counsellor (accredited practicing dietitian, APD). The initial consultation over the phone will be about 30-45 mins in duration and subsequent weekly follow up phone calls will be about 15-20 minutes in duration. Content of calls will be tailored to participants’ stage of change. For all stages, there will be a discussion of the diet-disease relationship, as well identification of appropriate goals, and arrangement of follow up calls. Participants in a ‘pre-contemplative’ or contemplative’ stage, will participate in calls that focus on self-reevaluation, environmental re-evaluation, and general dietary advice e.g. key food groups, and recommended serves. Participants in the ‘preparation’, and ‘action’ stages, will be engaged in calls that focus on goal setting, strategies to achieving goals, and discussion of barriers to change. A prospective, randomised trial design will be used to determine pre- and post-intervention changes in dietary intakes and behaviours. Intakes will be assessed using a validated 145-item Food Frequency Questionnaire (FFQ) and a Dietary Behaviour Questionnaire (DBQ). The FFQ and DBQ will be used at baseline, and 6 months post-intervention, while the DBQ alone will be used at the end of the 4-month intervention, and at 3 months. The intervention and controls group will be compared based on post-intervention intake levels and behaviour change. All participant contacts will be systematically tracked to allow for reporting on: the number of call attempts, completed calls (or ‘dose’ of intervention received), number of calls completed at the scheduled time (versus via call back), reasons for missed calls, and call duration. The call content will be tracked via checklists completed after each call allowing for reporting on the extent to which the intervention content is delivered per protocol, and the percentage of participants setting goals for dietary behaviours. At the end of the intervention, participants will be asked a set of questions that will help us understand their experience of the telephone coaching, including if they found it useful and whether they would recommend this to a friend. Using a Likert scale ranging from 0-5, they will be able to rate their satisfaction with the overall intervention content and the dietary messages provided, as well as their adherence to the dietary advice provided by the dietitian. Finally, they will be able to detail any suggestions on how this intervention could be improved. We will carry out ‘within trial’ cost-effectiveness analysis in which outcomes will be measured as clinically relevant improvements as per the FFQ and DBQ. The perspective taken will be that of health provider. We will collect data prospectively on the costs to deliver the intervention program (telephone calls, staff time, training, mail-outs, and any other intervention resources).

Sponsors

University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Prevention

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion criteria will include any patient diagnosed with age-related macular degeneration and who can read English.

Exclusion criteria

Exclusion criteria are: (a) lack sufficient fluency in spoken English to engage in the intervention; (b) unwilling to actively engage in the telephone-delivered coaching sessions over the 4 months; (c) inability to give informed consent.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 22, 2026