An interventional study of MedEx Tracker and Printed dietary and resistance exercise programme in Treatment Adherence and Compliance, Resistance Exercise and Mediterranean Diet, sponsored by Liverpool John Moores University. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Liverpool John Moores University · Not applicable, Interventional, and Prevention
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.
This is a four-week, two-arm, parallel-group feasibility randomised controlled trial conducted at Liverpool John Moores University. Healthy adults aged 18 to 55 years who own a smartphone will be randomised in a 1:1 ratio to an application-supported intervention arm (APP) or a control arm (CON). Allocation will be generated by a staff member independent of the project using a computerised random number generator. Blinding of participants is not feasible given the nature of the intervention; statistical analysis will be performed by a blinded statistician.
All participants, irrespective of allocation, will receive the same printed booklet containing Mediterranean-style dietary serving targets with serving size definitions and a structured resistance exercise programme with written technique guidance and load progression criteria, and will be asked to follow these to the best of their ability throughout the four-week intervention period. Participants in the APP arm will additionally receive access to MedEx Tracker, a purpose-built cross-platform mobile application. The application supports structured daily and weekly dietary logging against the prescribed serving targets, set-level recording of resistance exercise including load and repetitions, automated load progression prompts, an inter-set rest timer, embedded exercise demonstration videos, a library of Mediterranean recipes, and a progress dashboard displaying computed daily and weekly dietary compliance. Automated reminders are delivered three times daily for diet and every alternate day for exercise. Both arms therefore receive an identical prescription, with access to the application, and the self-monitoring, progress feedback and automated reminders it provides, representing the only difference between groups.
All participants will attend the laboratory before and after the intervention period. Primary outcomes are adherence to a Mediterranean-style diet and a resistance exercise programme, and the usability, acceptability and engagement with the application. Dietary adherence will be assessed using the 14-item Mediterranean Diet Adherence Screener and resistance exercise adherence as weekly muscle-strengthening frequency using the long form of the Muscle-Strengthening Exercise Questionnaire. Usability and acceptability will be assessed using the Mobile App Usability Questionnaire and the user version of the Mobile Application Rating Scale, supplemented by a focus group at follow-up. Engagement will be derived from application-generated data, including frequency of access and completeness of dietary and resistance exercise records. Secondary outcomes include recruitment and retention rates, dietary intake derived from three-day food records, body mass and body composition.
The study is not powered to detect definitive between-group differences. Its purpose is to establish whether the application functions as an adherence support and tracking tool of sufficient quality to be used within a subsequent fully powered trial examining LDL aggregation susceptibility.
128 studies on the registry are indexed under Treatment Adherence and Compliance; 64 are open to participants now.
This study's planned enrollment of 30 is below the median of 86 across 107 interventional studies indexed under Treatment Adherence and Compliance.
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Exclusion Criteria:
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 Tracker · Behavioral: Printed dietary and resistance exercise programme
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
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.
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.
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
Time frame: 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).
Time frame: Baseline and week 4
Application usability
Usability assessed in the intervention group using the Mobile App Usability Questionnaire (MAUQ). Higher scores indicate better usability.
Time frame: 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).
Time frame: 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.
Time frame: Weeks 1-4, recorded continuously by the application
Dietary intake
Energy and macronutrient intake derived from three-day food records.
Time frame: Baseline and week 4
Body mass
In kg using calibrated scales
Time frame: Baseline and week 4
Body composition
Fat mass and fat-free mass assessed by bioelectrical impedance analysis
Time frame: Baseline and week 4
Recruitment rate
Number of participants randomised per month of recruitment. Also reported: * number screened * proportion of those screened who are eligible * proportion of eligible people who consent and are randomised
Time frame: From the start of recruitment to randomisation of the final participant (up to approximately 4 months)
Retention rate
Proportion of randomised participants who attend the week-4 follow-up visit, reported overall and by arm, with reasons for withdrawal where given.
Time frame: Baseline to week 4 (end of intervention)
Plan to share: No — 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.
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