MediPD: An Online Mediterranean Diet Program for People Living With Parkinson's Disease

N/ANot Yet RecruitingNCT07838675

Queen's University, Belfast120 enrolled

Overview

The aim of this pilot study is to assess whether an online Mediterranean diet programme called MediPD is acceptable and practical for people living with Parkinson's disease, and whether it can help them make and maintain changes towards a Mediterranean-style diet. The study will include 120 adults living in the United Kingdom with Parkinson's disease who have access to an internet-enabled device and currently have low adherence to a Mediterranean-style diet. Participants will be randomly assigned to one of two groups. One group will receive access to the MediPD online programme, which includes short educational videos, personalised dietary information, practical resources, goal-setting tools, and online dietetic support. The other group will continue with their usual care and will receive access to MediPD after completing the final study assessment. Researchers will compare the groups to see whether MediPD improves adherence to a Mediterranean diet after 24 weeks. The study will also examine dietary intake, non-motor symptoms, quality of life, gastrointestinal symptoms, cognitive function, and how acceptable and practical the programme is to use. Assessments will take place at the start of the study, at 12 weeks, and at 24 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

120

Conditions

Parkinson Disease, Idiopathic

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Self-reported idiopathic Parkinson's disease * Age 18 years or older * Community-dwelling and resident in the United Kingdom * Access to an internet-enabled device and an active email address * Mediterranean Diet Score ≤7/13, indicating low adherence to a Mediterranean diet * Proficient in English * Able to provide informed consent Exclusion Criteria: * Atypical or secondary parkinsonism * Living in an institution * Self-reported body mass index \<18.5 kg/m² * High risk of malnutrition, defined as MUST score ≥2 * Receiving prescribed nutritional support * Significant cognitive impairment, defined as T-CogS ≤21 * Pregnancy * Active inflammatory bowel disease * Dysphagia requiring a pureed diet * Food allergies that would prevent adherence to a Mediterranean-style diet * Following a vegan diet that would prevent adherence to the study's Mediterranean-style dietary intervention. * Current participation in another interventional trial * Participation in an investigational medicinal product trial within the previous 90 days where this may affect study outcomes or participant burden * Previous participation in a My Moves Matter dietary programme.

Outcomes

Primary Outcomes

Change in Mediterranean Diet Adherence using a Mediterranean Diet Score at 24 Weeks

Adherence to a Mediterranean diet will be assessed using the Mediterranean Diet Score (MDS), derived from a validated 14-item questionnaire. Total scores range from 0 to 14, with higher scores indicating greater adherence to a Mediterranean diet.

Time frame: Baseline to 24 weeks

Secondary Outcomes

Change in Mediterranean Diet Adherence using a Mediterranean Diet Score at 12 Weeks

Time frame: Baseline to 12 weeks

Change in self-reported dietary intake using a 24-hour Dietary Recall

Dietary intake will be assessed using Intake24, an online 24-hour dietary recall tool. Outcomes will include mean daily intake of energy (kcal/day), foods and macronutrients (g/day and, where appropriate, percentage of energy), and micronutrients (mg or µg/day, as appropriate). Higher values indicate greater intake of food/nutrients.