Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001213336
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
4/09/2026
Date registered
Help: Date registered
30/09/2026
Date last updated
Help: Date last updated
30/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
30/09/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
REMEDI: Randomised Evaluation of a Mediterranean Dietary Intervention for Anxiety and Depression in Australian Adults
Scientific title
Mediterranean Dietary Pattern and Anxiety Symptoms in Adults: Randomised Controlled Trial
Additional trial identifiers [1] 313050 0
Nil
Universal Trial Number (UTN)
Trial acronym
REMEDI
Related trial records

Health condition
Health condition(s) studied:
Anxiety symptoms 335273 0
Depressive symptoms 335274 0
Condition category
Condition code
Mental Health 331847 331847 0 0
Anxiety
Mental Health 339689 339689 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
12-Week Mediterranean Dietary Intervention
Participants randomised to the intervention arm will undertake a 12-week Mediterranean-style dietary program designed to improve adherence to Mediterranean dietary principles and reduce symptoms of anxiety and depression. The intervention combines individual dietetic counselling, educational materials, digital self-monitoring, and food provision to support dietary change.

Participants will attend three individual dietary consultation sessions at baseline (week 0), week 6, and week 12. Each consultation will last approximately 45 to 60 minutes and will be delivered on a one-to-one basis. The baseline and week 12 consultations will typically be conducted in person, with the week 6 consultation delivered via telehealth where appropriate. Sessions will be provided by an Accredited Practising Dietitian or final-year dietetics students who have completed clinical placement requirements and are supervised by an APD.

The dietary program is based on a Mediterranean dietary pattern adapted for Australian food availability and affordability. Participants will be encouraged to increase consumption of vegetables, fruits, legumes, wholegrains, nuts, seeds, extra-virgin olive oil, and fish, while reducing intake of processed foods, refined carbohydrates, added sugars, and processed meats. Counselling will incorporate motivational interviewing and behaviour-change techniques, including goal setting, problem-solving, meal planning, budgeting, food purchasing, food preparation skills, storage strategies, and guidance for making Mediterranean-style choices in restaurants, cafés, and other social settings.

Participants will receive the REMEDI Mediterranean Diet Workbook at baseline. The workbook contains a structured 12-week dietary program including educational information about Mediterranean diet principles, weekly food-group focused modules, shopping guides, meal plans, serving-size recommendations, recipes, budget-conscious food selection strategies, culturally adaptable food substitutions, mindful eating guidance, behaviour-change activities, self-monitoring worksheets, weekly reflection activities, and goal-setting exercises.

Participants will also receive access to the REMEDI smartphone application, which supports dietary self-monitoring throughout the intervention. Participants will be asked to log meals daily. The app uses artificial intelligence to assess meal entries against Mediterranean diet principles, provide dietary adherence feedback, identify plant foods consumed, and track progress towards a goal of consuming 30 different plant foods per week. The app also contains weekly monitoring functions used for participant follow-up and safety monitoring.

To support intervention implementation, participants will receive:

A starter food hamper at commencement of the intervention containing Mediterranean dietary staples such as extra-virgin olive oil, legumes, wholegrains, canned fish, nuts and seeds or a AUD$30 supermarket voucher at baseline and an additional AUD$30 supermarket voucher at week 6 to subsidise purchase of Mediterranean diet foods.
Where available, an additional smaller food hamper at week 6 to reinforce adherence.

Monitoring of Adherence

Adherence to the intervention will be monitored using multiple methods:

1. Daily meal logging within the REMEDI smartphone application.
2. Automated app-based analysis of Mediterranean diet adherence.
3. Weekly app-based monitoring of plant diversity consumption.
4. Weekly participant mental health check-ins through the app.
5. Review of app-recorded dietary data during dietetic consultations.
6. Mediterranean Diet Adherence Screener (MEDAS) administered at baseline, week 6, and week 12.
7. Dietary Questionnaire for Epidemiological Studies Version 2 (DQES v2) administered at baseline and week 12.
8. Skin carotenoid assessment at baseline and week 12 as an objective biomarker of fruit and vegetable intake.
Intervention code [1] 329604 0
Lifestyle
Description of the comparator or control
Befriending Control Group (Comparator)

Participants randomised to the control arm will receive a 12-week befriending intervention designed to control for non-specific therapeutic factors including attention, empathy, expectancy, routine contact, and social interaction, while excluding dietary counselling or behaviour-change support. Participants will be asked to maintain their usual diet and lifestyle practices throughout the study period. The befriending intervention serves as a time- and attention-matched comparator to the Mediterranean dietary intervention.

Participants will attend three individual befriending sessions delivered at baseline (week 0), week 6, and week 12. Each session will last approximately 45-60 minutes, matching the frequency and duration of the dietary intervention consultations. Sessions will be conducted on a one-to-one basis, using the same delivery mode as the intervention group (face-to-face and/or telehealth as appropriate).

The befriending sessions involve structured neutral conversation and social engagement. Facilitators will encourage discussion about everyday topics such as hobbies, films, television programs, music, sport, travel, pets, and general interests. Facilitators will utilise active listening and conversational engagement techniques but will not provide dietary advice, psychological counselling, psychotherapy, behaviour-change strategies, or mental health treatment.

The control treatment will be delivered by trained research personnel, an Accredited Practising Dietitian (APD), an occupational therapist, or supervised final-year Bond University dietetics or occupational therapy students who have received training in the standardised befriending protocol.

Materials Provided

No dietary education materials, workbook, food hampers, supermarket vouchers, dietary resources, or smartphone dietary self-monitoring tools will be provided during the intervention period.

Participants will receive:

1. Weekly online wellbeing and safety-monitoring surveys delivered via Qualtrics and/or text message link throughout the 12-week intervention period.
2. Access to the Mediterranean Diet Workbook, REMEDI app and educational materials after completion of study participation.

Monitoring and Adherence

Adherence to the control treatment will be monitored through:

1. Attendance records for the three scheduled befriending sessions.
2. Completion of weekly online monitoring surveys.
3. Weekly safety monitoring assessing medication or supplement changes, adverse health effects, worsening mood or anxiety symptoms, concerns about continuing participation, and general wellbeing. All responses will be reviewed by the research team, with follow-up undertaken where required.

Additional Components of the Control Condition

To acknowledge participant time commitment and support retention, participants allocated to the control group will receive a AUD$50 movie gift card upon completion of the 12-week study period.

Following completion of the 12-week intervention period and endpoint assessments, participants in the control group will be offered access to the REMEDI Mediterranean Diet Workbook, REMEDI app, educational dietary materials, and their individual microbiome results (where applicable). No dietetic consultations, food hampers, supermarket vouchers will be provided after study completion
Control group
Active

Outcomes
Primary outcome [1] 339465 0
Anxiety Symptoms
Timepoint [1] 339465 0
Baseline Week 6 post-intervention commencement Week 12 post-intervention commencement
Secondary outcome [1] 440087 0
Depressive symptoms
Timepoint [1] 440087 0
Baseilne Week 6 post-intervention commencement Week 12 post-intervention commencement
Secondary outcome [2] 468272 0
Stress
Timepoint [2] 468272 0
Baseline Week 6 post-intervention commencement Week 12 post-intervention commencement
Secondary outcome [3] 468274 0
Social connectedness
Timepoint [3] 468274 0
Baseline Week 6 post-intervention commencement Week 12 post-intervention commencement
Secondary outcome [4] 468283 0
Physical activity
Timepoint [4] 468283 0
Baseline 12 weeks post-intervention commencement
Secondary outcome [5] 468288 0
Sleep quality
Timepoint [5] 468288 0
Baseline 12 weeks post-intervention commencement
Secondary outcome [6] 468290 0
Quality of life
Timepoint [6] 468290 0
Baseline 6 weeks post-intervention commencement 12 weeks post-intervention commencement
Secondary outcome [7] 468295 0
Alcohol consumption
Timepoint [7] 468295 0
Baseline 12 weeks post-intervention commencement
Secondary outcome [8] 468299 0
Medication/supplement changes
Timepoint [8] 468299 0
Baseline 6 weeks post-intervention commencement 12 weeks post-intervention commencement
Secondary outcome [9] 468300 0
Mediterranean dietary adherence
Timepoint [9] 468300 0
Baseline 6 weeks post-intervention commencement 12 weeks post-intervention commencement
Secondary outcome [10] 468301 0
Diet quality
Timepoint [10] 468301 0
Baseline 12 weeks post-intervention commencement
Secondary outcome [11] 468302 0
Skin carotenoids
Timepoint [11] 468302 0
Baseline 12 weeks post-intervention commencement
Secondary outcome [12] 468303 0
Gut microbiome diversity (optional)
Timepoint [12] 468303 0
Baseline 12 weeks post-intervention commencement

Eligibility
Key inclusion criteria
Community-dwelling Australian adults aged 18–65 years who:

Report symptoms of anxiety and/or depression, meeting DASS-21 subscale thresholds for moderate-to-severe symptom severity (established norms; see Appendix 1 of the protocol).
Demonstrate below-average diet quality, indicated by a score of less than 75 out of 104 on the Dietary Screening Tool (DST).
Are available to participate in the full 12-week intervention period and maintain their usual treatment regimen (e.g., prescribed medication and/or counselling) throughout the study.
Are willing and able to attend in-person assessment visits at the Bond Institute of Health and Sport (BIHS), Robina, Gold Coast.
Are able to read and communicate in English and provide informed consent.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Potential participants will be excluded if they:

Score 2 or more on the SCOFF eating disorder screening questionnaire (administered at telephone screening), indicating possible eating disorder risk.
Are unable to read or communicate in English.
Have a diagnosed comorbid psychiatric condition requiring specialised clinical management that may interfere with participation (e.g., bipolar disorder, schizophrenia, active substance use disorder, or an eating disorder).
Report a severe gastrointestinal disorder likely to be exacerbated by dietary change.
Follow a restrictive or exclusionary dietary pattern incompatible with the Mediterranean-style intervention.
Are currently participating in another dietary or lifestyle intervention study.
Are unwilling or unable to attend scheduled in-person assessments at the Bond Institute of Health and Sport (BIHS) or to provide required biological samples.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be achieved using sequentially numbered, sealed opaque envelopes prepared by an independent member of the research team who is not involved in participant recruitment, screening, baseline assessment, or enrolment. The randomisation sequence will be generated using a computer-based random number generator by an independent researcher. Following completion of baseline assessments and confirmation of eligibility, the next envelope in sequence will be opened to reveal the participant's treatment allocation. This process ensures that group assignment cannot be predicted or influenced prior to enrolment and randomisation. Outcome assessors and data analysts will remain blinded to treatment allocation throughout the study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
An a priori power analysis (G*Power 3.1) indicated that 52 participants (26 per group) are required to detect a moderate effect size (f = 0.25) on the primary outcome (GAD-7), assuming a = .05 (two-tailed) and 80% power. To account for anticipated attrition of approximately 25%, consistent with prior lifestyle-based RCTs (SMILES, AMMEND), the target recruitment sample is 70 participants (35 per group).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
14/09/2026
Date of last participant enrolment
Anticipated
31/12/2027
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
70
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 317490 0
University
Name [1] 317490 0
FSD Deans Award Research Grant - Bond University
Country [1] 317490 0
Australia
Funding source category [2] 323070 0
Government body
Name [2] 323070 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO)
Country [2] 323070 0
Australia
Primary sponsor type
University
Name
Bond University
Address
Country
Australia
Secondary sponsor category [1] 319783 0
University
Name [1] 319783 0
Griffith University
Address [1] 319783 0
Country [1] 319783 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316203 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 316203 0
Ethics committee country [1] 316203 0
Australia
Date submitted for ethics approval [1] 316203 0
17/07/2026
Approval date [1] 316203 0
31/08/2026
Ethics approval number [1] 316203 0
AG01582

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137130 0
A/Prof Megan Lee
Address 137130 0
Bond University; 14 University Drive, Robina, Queensland, 4226
Country 137130 0
Australia
Phone 137130 0
+61 415643743
Fax 137130 0
Email 137130 0
[email protected]
Contact person for public queries
Name 137131 0
Megan Lee
Address 137131 0
Bond University; 14 University Drive, Robina, Queensland, 4226
Country 137131 0
Australia
Phone 137131 0
+61 415643743
Fax 137131 0
Email 137131 0
[email protected]
Contact person for scientific queries
Name 137132 0
Megan Lee
Address 137132 0
Bond University; 14 University Drive, Robina, Queensland, 4226
Country 137132 0
Australia
Phone 137132 0
+61 415643743
Fax 137132 0
Email 137132 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Public through Open Science Framework

What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
• Baseline and post measurements

What types of analyses could be done with individual participant data?
• Descriptive and inferential data

When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Journal publication or its supplementary materials: Protocol and Results publication in the British Journal of Nutrition

• Email of trial custodian, sponsor or committee: Dr Megan Lee - [email protected]

• Open Science Framework Registry (will be established after protocol publication).



Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
ProtocolYes under review British Journal of Nutrition Manuscript.docx

Documents added automatically
No additional documents have been identified.