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Trial registered on ANZCTR


Registration number
ACTRN12619001545156
Ethics application status
Approved
Date submitted
24/10/2019
Date registered
8/11/2019
Date last updated
12/02/2020
Date data sharing statement initially provided
8/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised control trial assessing the effect of a Mediterranean diet on the symptoms of depression in young men (the “AMMEND” study)
Scientific title
A randomised control trial assessing the effect of a Mediterranean diet on the symptoms of depression in young men (the “AMMEND” study)
Secondary ID [1] 299635 0
None
Universal Trial Number (UTN)
U1111-1242-5215
Trial acronym
AMMEND
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Depression 314952 0
Condition category
Condition code
Mental Health 313299 313299 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be allocated to either follow a Mediterranean Diet (MD) or Social support for 12 weeks. Participants will continue with there current medications and/or psychology appointments. A Mediterranean diet is high in wholegrains, fruits and vegetables, legumes, nuts and seeds and plenty of olive oil, it is low in processed or “fast foods” and high sugar snack foods and beverages. Participants in the MD group will follow the diet for all meals and snacks for 12 weeks. Participants will be provided with a food hamper at the beginning of the trial which included diet staples such as olive oil, nuts and vegetables to get them started and will then buy and cook their own food. They will be provided with comprehensive handouts designed specifically for this study including diet guidelines, meal ideas and example diet plan. The diet will be administered by a qualified nutritionist who participants will meet with at baseline (week 0), week 6 and week 12 for 1 hour. Diet adherence will be monitored by an online food diary (created on surveygizmo for the purpose of this study) which is reported daily.
Intervention code [1] 315895 0
Lifestyle
Intervention code [2] 315968 0
Treatment: Other
Comparator / control treatment
The Comparator treatment will be social support. Participants will engage in an activity called ‘befriending’ which involves talking with the researcher for an hour about various topics of interest or importance to you. These may include sports, movies, work, study, hobbies or any other topic of interest. This is not a counselling or psychology appointment and participants must continue with their prescribed mental health plan. This will follow the same treatment schedule as the MD group. 1 hour sessions at baseline (week 0) week 6 and week 12.

Control group
Active

Outcomes
Primary outcome [1] 321779 0
Changes in Becks Depression Inventory Score
Timepoint [1] 321779 0
Measured at baseline, 6 weeks and 12 weeks (primary time point)
Secondary outcome [1] 376180 0
World Health Organisation Quality of Life Score
Timepoint [1] 376180 0
Measured at baseline, 6 weeks and 12 weeks
Secondary outcome [2] 376543 0
End of project evaluation survey to determine perceived challenges of following the diet designed specifically for use in this study.
Timepoint [2] 376543 0
at week 12 conclusion of trial
Secondary outcome [3] 376544 0
Mediterranean adherence score (Validated 14-item Questionnaire of Mediterranean diet adherence)
Timepoint [3] 376544 0
Assessed at week 6 and week 12

Eligibility
Key inclusion criteria
The study population will consist of:
1. Young men aged 18-25
2. Diagnosed with depression by GP or psychologist
3. Received a “poor” diet score (<40) on the CSIRO Healthy diet score survey.
Minimum age
18 Years
Maximum age
25 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
1. If they can’t speak or understand English
2. If they are not capable of understanding or consenting what is involved with this trail
3. If they are also diagnosed with any of the following mental health disorders: Bipolar disorder, post-traumatic stress, personality disorders, eating disorders, psychotic disorders such as schizophrenia or a substance abuse disorder such as alcoholism.
4. If they have any food allergies, intolerances or eversions (avoiding foods based on religious or ethical grounds).
5. If they are unavailable to attend the scheduled follow up appointment.
6. If they are unwilling to change their diet if allocated to the Mediterranean diet group.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
randomisation via computer generated sequence and sealed opaque envelopes
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
N/A
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size was calculated in order to measure a minimum clinically important change of >5 points in BDI while comparing diet and placebo group with a type I error a=0.05 and type II error (ß) of 0.20 (power = 80%). In previous studies the response within each subject group was normally distributed with an approximate standard deviation of 7.5. Based on this, 36 participants are needed per group. Allowing for a 15% dropout rate, we are aiming to recruit 86 participants.

Statistical analysis will be performed using STATA. Descriptive statistics will be reported using means and standard deviations providing baseline demographics and measurements. Nominal data will undergo t-tests or Chi Square to ensure that there are no differences between randomised groups. Variables that are not normally distributed will be either transformed or analysed using nonparametric methods. Where assumptions of normality are met, linear modelling will be used to compare changes in the groups over time while adjusting for covariates.

The main outcome will be the Becks Depression Inventory (BDI) score which will be analysed as a continuous variable and reported as a mean. A one-tailed analysis will be used to detect differences in BDI scores between the intervention and control groups. Intention to treat analysis will be used exploring dose–response effects associated with the Mediterranean diet adherence. Changes between BDI score at baseline and the conclusion of the study will be analysed using paired t-tests. Differences in BDI scores between both groups will be assessed by analysis of covariance (ANCOVA) using a general linear model. Regression analysis will be used to compare groups after adjusting for confounders.

To investigate whether dietary change is associated with positive outcomes in depression, changes in diet scores will be entered into correlation or regression analyses as appropriate with changes in BDI scores as dependent variables. Sub-group analyses by depression severity score will be conducted to determine if the severity of depression effects the results. Changes to BDI scores will be represented by ß coefficients, 95% Confidence Intervals (CI) and p-values. Effect sizes will be calculated using Cohen’s guidelines. All tests of treatment effects will be conducted using an alpha level of 0.05. Missing data will be accounted for using multiple imputation.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 28324 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 304109 0
University
Name [1] 304109 0
Endeavour College of Natural Health
Address [1] 304109 0
Level 2/269 Wickham St, Fortitude Valley QLD 4006
Country [1] 304109 0
Australia
Funding source category [2] 304112 0
University
Name [2] 304112 0
University of Technology Sydney
Address [2] 304112 0
15 Broadway, Ultimo NSW 2007
Country [2] 304112 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
15 Broadway, Ultimo NSW 2007
Country
Australia
Secondary sponsor category [1] 304326 0
University
Name [1] 304326 0
Endeavour College of natural health
Address [1] 304326 0
Level 2/269 Wickham St, Fortitude Valley QLD 4006
Country [1] 304326 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304599 0
University of Technology Sydney HREC
Ethics committee address [1] 304599 0
15 Broadway, Ultimo NSW 2007
Ethics committee country [1] 304599 0
Australia
Date submitted for ethics approval [1] 304599 0
18/11/2019
Approval date [1] 304599 0
04/02/2020
Ethics approval number [1] 304599 0
UTS HREC REF NO. ETH19-4413.

Summary
Brief summary
The AMMEND study is a 3-month randomised control trial testing the effect of a Mediterranean diet (MD) on the symptoms of depression in young men. Participants will be randomly allocated to either the MD group or the control group, which consists of a social support “befriending” protocol, via a computer-generated block randomisation sequence.

At the baseline appointment participants will complete a number of questionnaires and baseline measurements which will be recorded in the Case Report Form, including the Becks Depression Inventory depression scale and a short Dietary Screener Questionnaire (DSQ). Participants will have scheduled follow up appointments at 6 weeks and 12 weeks. Participants in the MD group will complete Diet History Forms to check levels of adherence to the diet and will be scored against the MD Adherence Score. The main outcome measure will be any changes to the BDI depression scale results. At the conclusion of the trial, participants in the MD group will complete a short, electronic, self-administered survey assessing their experiences and perceived benefits and challenges of continuing to follow a Mediterranean diet long term.
Trial website
https://mendds.wixsite.com/ammend
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 97530 0
Ms Jessica Bayes
Address 97530 0
Jessica Bayes Nutrition, 12 Wellington Parade, East Melbourne, 3002, Victoria, Australia
Country 97530 0
Australia
Phone 97530 0
+61401962947
Fax 97530 0
Email 97530 0
jessica.c.bayes@student.uts.edu.au
Contact person for public queries
Name 97531 0
Ms Jessica Bayes
Address 97531 0
Jessica Bayes Nutrition, 12 Wellington Parade, East Melbourne, 3002, Victoria, Australia
Country 97531 0
Australia
Phone 97531 0
+61401962947
Fax 97531 0
Email 97531 0
jessica.c.bayes@student.uts.edu.au
Contact person for scientific queries
Name 97532 0
Ms Jessica Bayes
Address 97532 0
Jessica Bayes Nutrition, 12 Wellington Parade, East Melbourne, 3002, Victoria, Australia
Country 97532 0
Australia
Phone 97532 0
+61401962947
Fax 97532 0
Email 97532 0
jessica.c.bayes@student.uts.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication to 5 years after publication.
Available to whom?
Other researchers may seek permission to see the raw de-identified data upon request from the primary researcher
Available for what types of analyses?
For any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator: jessica.c.bayes@student.uts.edu.au
What supporting documents are/will be available?
No other documents available
Summary results
No Results