NCT07838675

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
17mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Sep 2026Feb 2028

First Submitted

Initial submission to the registry

September 10, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 24, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

September 28, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2028

Last Updated

September 24, 2026

Status Verified

September 1, 2026

Enrollment Period

1.2 years

First QC Date

September 10, 2026

Last Update Submit

September 17, 2026

Conditions

Keywords

Mediterranean DietParkinson DiseaseDigital HealthOnline InterventionFeasibility StudyPilot Randomized Controlled TrialNon-Motor Symptoms

Outcome Measures

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.

    Baseline to 24 weeks

Secondary Outcomes (6)

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

    Baseline to 12 weeks

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

    Baseline, 12 weeks and 24 weeks.

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

    Baseline, 12 weeks and 24 weeks.

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

    Baseline, 12 weeks and 24 weeks.

  • Change in quality of life using the Parkinson's Disease Questionnaire (PDQ-39)

    Baseline, 12 weeks and 24 weeks.

  • +1 more secondary outcomes

Other Outcomes (2)

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

    Baseline, 12 weeks and 24 weeks.

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

    Week 24

Study Arms (2)

MediPD Intervention

EXPERIMENTAL

Participants will receive access to the 12-week MediPD online Mediterranean diet behaviour-change program

Behavioral: MediPD Online Mediterranean Diet Program

Wait-List Control

NO INTERVENTION

Participants will continue to receive their usual care. After completing the final 24-week study assessment, participants in the wait-list control group will be offered access to the MediPD online program for 12 weeks.

Interventions

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.

MediPD Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Claire T McEvoy, PhD, Mphil, RD

    Queens University Belfast

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola A Ward, PhD, MSci

CONTACT

Sinead O'Hagan, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The Principal Investigator and statistician conducting the outcome analysis will remain blinded to treatment allocation. Participants cannot be blinded because of the nature of the online dietary intervention. Group allocation will be revealed to participants following completion of baseline assessments.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Claire McEvoy, PhD, Mphil, RD, Reader, Nutrition and Ageing Research

Study Record Dates

First Submitted

September 10, 2026

First Posted

September 24, 2026

Study Start

September 28, 2026

Primary Completion (Estimated)

November 28, 2027

Study Completion (Estimated)

February 29, 2028

Last Updated

September 24, 2026

Record last verified: 2026-09