NCT07885254

Brief Summary

Eating a Mediterranean-style diet and doing regular resistance training are both known to lower the risk of heart disease. However, most people find it hard to stick to these habits over time, and few smartphone apps support both diet and strength training together. This study tests a smartphone app called MedEx Tracker, which was developed by the research team. The app lets people record what they have eaten against a set of Mediterranean diet targets, record the weight and repetitions for each set of their resistance training, and see how they are doing through a progress screen. It also sends reminders during the day and suggests when to increase training weight. Healthy adults aged 18 to 55 will be randomly assigned to one of two groups. Both groups will be given the same Mediterranean diet targets and the same strength training programme. One group will receive this through the app; the other will receive it as a printed booklet. This means any difference between the groups should be due to the app itself rather than to different advice. Everyone will attend the laboratory before and after the four weeks for measurements and questionnaires. The main aim is to find out whether the app is usable and acceptable to participants, and whether it helps people stick to a Mediterranean-style diet and a resistance training programme. The findings will be used to decide whether the app is suitable for a larger future study.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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 Progress14%
Oct 2026Mar 2027

Study Start

First participant enrolled

October 1, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 21, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

October 21, 2026

Status Verified

October 1, 2026

Enrollment Period

4 months

First QC Date

October 9, 2026

Last Update Submit

October 13, 2026

Conditions

Keywords

mHealthmobile applicationmediterranean dietresistance trainingdietary adherenceexercise adherencebehaviour changeself-monitoringfeasibility study

Outcome Measures

Primary Outcomes (5)

  • Mediterranean diet adherence

    Adherence measured using the 14-item Mediterranean Diet Adherence Screener (MEDAS). Total score ranges from 0 to 14, with higher scores indicating greater adherence

    Baseline and week 4

  • Resistance training adherence

    Weekly muscle-strengthening frequency (days per week) assessed using the long form of the Muscle-Strengthening Exercise Questionnaire (MSEQ).

    Baseline and week 4

  • Application usability

    Usability assessed in the intervention group using the Mobile App Usability Questionnaire (MAUQ). Higher scores indicate better usability.

    Week 4 (end of intervention)

  • Application quality and acceptability

    Assessed in the intervention group using the user version of the Mobile Application Rating Scale (uMARS), scored across engagement, functionality, aesthetics and information quality. Scoring is 1-5 (higher= better).

    Week 4 (end of intervention)

  • Engagement with the application

    Frequency of application access and completeness of dietary and resistance training records, derived from application-generated data in the intervention group.

    Weeks 1-4, recorded continuously by the application

Secondary Outcomes (5)

  • Dietary intake

    Baseline and week 4

  • Body mass

    Baseline and week 4

  • Body composition

    Baseline and week 4

  • Recruitment rate

    From the start of recruitment to randomisation of the final participant (up to approximately 4 months)

  • Retention rate

    Baseline to week 4 (end of intervention)

Study Arms (2)

Application-supported

EXPERIMENTAL

Participants receive Mediterranean-style dietary serving targets and a structured resistance exercise programme as a printed booklet, together with access to the MedEx Tracker mobile application, which provides self-monitoring, progress feedback, automated reminders and load progression prompts over four weeks.

Behavioral: MedEx TrackerBehavioral: Printed dietary and resistance exercise programme

Printed booklet

ACTIVE COMPARATOR

Participants receive the same printed booklet containing Mediterranean-style dietary serving targets and a structured resistance exercise programme over four weeks. No application access, progress feedback or automated reminders are provided.

Behavioral: Printed dietary and resistance exercise programme

Interventions

MedEx TrackerBEHAVIORAL

MedEx Tracker is a purpose-built cross-platform smartphone application developed by the research team to support adherence to a Mediterranean-style diet and a resistance training programme. Participants record daily servings of six food groups and weekly servings of five further food groups against defined targets, with serving definitions available within the application. Resistance training is recorded at the level of individual sets, capturing the load lifted and repetitions completed, with demonstration videos, automated prompts to increase or reduce load based on previous performance, and an inter-set rest timer. A progress dashboard displays a computed daily and weekly dietary compliance percentage, sessions completed, and seven-day activity calendars. The application also provides a library of Mediterranean diet-aligned recipes and delivers automated reminders three times daily for diet and every alternate day for exercise.

Application-supported

A printed booklet containing Mediterranean-style dietary serving targets with accompanying serving size definitions, and the prescribed resistance exercises with written technique guidance and load progression criteria. Participants are asked to follow the programme to the best of their ability over the four-week study period.

Application-supportedPrinted booklet

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • own and use a smartphone
  • no contraindication to exercise on a pre-activity readiness questionnaire (PARQ)

You may not qualify if:

  • pregnant or nursing
  • presence of a dietary allergy or food intolerance
  • adherence to a restrictive diet (keto, carnivore, vegan, vegetarian etc)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liverpool John Moores University

Liverpool, Merseyside, L3 3AF, United Kingdom

Location

MeSH Terms

Conditions

Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Richard P Kirwan, PhD

    Liverpool John Moores University

    STUDY DIRECTOR

Central Study Contacts

Alexandros M Amorginos, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Blinded statistician
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2026

First Posted

October 21, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

October 21, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made publicly available. The small sample size and single-site recruitment mean that participants could potentially be identified from combinations of demographic and anthropometric variables. Requests for data access will be considered on an individual basis by the corresponding author, subject to approval by the Liverpool John Moores University Research Ethics Committee and completion of a data sharing agreement.

Locations