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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorQueen's University, Belfast

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • MediPD Online Mediterranean Diet Program

    Behavioral

    MediPD is a 12-week online Mediterranean diet behaviour-change programme for people with Parkinson's disease. It provides personalised educational videos, practical resources, self-monitoring tools, and moderated dietetic support. Participants are encouraged to complete at least one module per week, aiming to adopt and maintain Mediterranean-style dietary changes over 24 weeks.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: MediPD InterventionExperimental treatment 1 intervention
Group B: Wait-List ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

1

Change in Mediterranean Diet Adherence using a Mediterranean Diet Score at 12 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 12 weeks
2

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.

Time frame
Baseline, 12 weeks and 24 weeks.
3

Change in Parkinson's Disease Non-Motor Symptoms using the Movement Disorder Society Non-Motor Rating Scale (MDS-NMS)

Non-motor symptoms will be assessed using the validated 52-item, rater-administered Movement Disorder Society Non-Motor Rating Scale (MDS-NMS). Total scores range from 0 to 832, with higher scores indicating a greater non-motor symptom burden and a worse outcome.

Time frame
Baseline, 12 weeks and 24 weeks.
4

Change in reported Gastrointestinal Symptoms using the Gastrointestinal Symptom Rating Scale (GSRS)

Gastrointestinal symptoms will be assessed using the 15-item Gastrointestinal Symptom Rating Scale (GSRS). Items are scored from 1 to 7 and summed to provide a total score ranging from 15 to 105. Higher total scores indicate greater gastrointestinal symptom severity and therefore a worse outcome.

Time frame
Baseline, 12 weeks and 24 weeks.

Other outcomes

1

Change in whole-gut transit time using the Blue Poop Challenge (optional assessment)

Consenting participants who opt into this assessment will consume a standardised food-grade blue dye preparation and record the date and time of ingestion and the first appearance of blue colouring in their stool. Whole-gut transit time will be calculated as the elapsed time in hours between ingestion and the first appearance of blue stool. Higher values indicate a longer, slower whole-gut transit time.

Time frame
Baseline, 12 weeks and 24 weeks.
2

Intervention acceptability using a study-specific semi-structured qualitative interview

Intervention acceptability will be explored through a study-specific semi-structured interview with a purposive sample of approximately 10-15 participants from the MediPD intervention group. Interviews will explore satisfaction and acceptability, relevance and usefulness, engagement, feasibility, platform usability, perceived impact, participant burden, barriers and facilitators, and suggestions for improvement. Interviews will be audio-recorded, transcribed verbatim and analysed qualitatively to identify key themes. This assessment does not generate a numerical score and therefore has no minimum or maximum value.

Time frame
Week 24

Locations

This trial has no locations.

Sponsors and contacts

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