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Trial registered on ANZCTR


Registration number
ACTRN12612000251820
Ethics application status
Approved
Date submitted
20/02/2012
Date registered
29/02/2012
Date last updated
10/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Diet as a therapeutic target in depression: A randomised controlled trial
Scientific title
Efficacy of a dietary intervention versus a control condition for reducing depression in individuals with major depressive disorder after 3 and 6 months
Secondary ID [1] 279969 0
n/a
Universal Trial Number (UTN)
Trial acronym
DIET RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depression 285887 0
Condition category
Condition code
Mental Health 286077 286077 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After a screening visit, participants will be randomly allocated to either a dietary intervention group or a social support control condition. The intervention will consist of 3 weekly educational and counselling sessions, targeting diet, followed by 4 two-weekly booster sessions. In each of the sessions, background information as well as strategies to address dietary change and adherence will be presented. At the commencement, each participant will be provided with a sample meal plan and selected ingredients: oil, margarine and, nuts (e.g. walnuts as high in n-3 PUFA) for snacks (over the duration of the study). Examples of portions of fish and lean cuts of meat will also be provided. Sessions will be one on one, face to face and approximately 1 hour in length.
Intervention code [1] 284307 0
Treatment: Other
Intervention code [2] 284379 0
Lifestyle
Intervention code [3] 284380 0
Behaviour
Comparator / control treatment
The control condition will comprise a befriending protocol, operating using the same visit schedule and length as the intervention (i.e over a 12 week period). Befriending is the benchmark control condition in psychosocial research and consists of a therapist talking about neutral topics of interest to the client (music, sport etc.) that are exclusive of emotionally loaded topics, with the intention of keeping the client engaged and positive about the control ‘intervention’. Befriending has been demonstrated to be highly effective as a control condition as it is manualised, easy for the therapist to learn, and acceptable to participants. The control group will also undergo physical assessments (weight, height etc.), blood tests, and complete Food Frequency Questionnaires, physical activity and smoking questionnaires, at the beginning and end of the intervention. In order to enhance recruitment, all individuals in the control condition will be offered the active intervention at the end of the study period (i.e. 3 months post-trial completion, after final assessment).
Control group
Active

Outcomes
Primary outcome [1] 286554 0
The primary outcome measures will be change in symptoms of
depression, measured by the Montgomery-Asberg Depression Rating Scale (MADRS)
Timepoint [1] 286554 0
Screening, Baseline (week 1), 3 months (post-baseline), 6 months (post-baseline)
Secondary outcome [1] 296152 0
Depression severity - Clinical Global Impression Scales (CGI) (Severity and Improvement)
Timepoint [1] 296152 0
3 months (post-baseline)
Secondary outcome [2] 296298 0
Anxiety- Hospital Anxiety and Depression Scale (HADS)
samples
Timepoint [2] 296298 0
Baseline (week 1), 3 months (post-baseline), 6 months (post-baseline)
Secondary outcome [3] 296299 0
Quality of Life- Short Form (SF 36), the WHO well-being index, Assessment of Quality of Life (AQoL 8D)
Timepoint [3] 296299 0
Baseline (week 1), 3 months (post-baseline)
Secondary outcome [4] 296300 0
Blood pressure- Sphygmomanometer
Timepoint [4] 296300 0
Baseline (week 1), 3 months (post-baseline)
Secondary outcome [5] 296301 0
Medication for blood pressure (self report)
Timepoint [5] 296301 0
Baseline (week 1), 3 months (post-baseline)
Secondary outcome [6] 296302 0
Plasma fatty acids and carotenoids (fasting blood samples)
Timepoint [6] 296302 0
Baseline (week 1), 3 months (post-baseline)
Secondary outcome [7] 296303 0
High Density Lipoproteins (HDL), Low Density Lipoproteins (LDL), Cholesterol (venous fasting blood samples)
Timepoint [7] 296303 0
Baseline (week 1), 3 months (post-baseline)
Secondary outcome [8] 296304 0
Haemoglobin A1C (fasting blood samples)
Timepoint [8] 296304 0
Baseline (week 1), 3 months (post-baseline)
Secondary outcome [9] 296305 0
Haemoglobin A1C (fasting blood samples)
Timepoint [9] 296305 0
Baseline (week 1), 3 months (post-baseline)
Secondary outcome [10] 296306 0
Blood glucose (fasting blood samples)
Timepoint [10] 296306 0
Baseline (week 1), 3 months (post-baseline)
Secondary outcome [11] 296307 0
triglycerides (fasting blood samples)
Timepoint [11] 296307 0
Baseline (week 1), 3 months (post-baseline)
Secondary outcome [12] 296308 0
Physical Activity (Active Australia)
Timepoint [12] 296308 0
Screening, 3 months (post-baseline)
Secondary outcome [13] 296309 0
Diet (Food Frequency Questionnaire, Dietary Screening Tool and food diary)
Timepoint [13] 296309 0
Screening, 3 and 6 months
Secondary outcome [14] 296310 0
Smoking (Food Frequency Questionnaire)
Timepoint [14] 296310 0
Screening, 3 months
Secondary outcome [15] 296311 0
Alcohol (Food Frequency Questionnaire)
Timepoint [15] 296311 0
Screening, 3 months
Secondary outcome [16] 296312 0
Weight and waist
Timepoint [16] 296312 0
Baseline (week 1), 3 months (post-baseline)
Secondary outcome [17] 296313 0
Cost efficacy (Assessment of Quality of Life (AQoL 8D)
Timepoint [17] 296313 0
Baseline (week 1), 3 months (post-baseline)
Secondary outcome [18] 303581 0
C-Reactive protein (venous fasting sample-fasting)
Timepoint [18] 303581 0
Baseline (week 1), 3 months (post-baseline)
Secondary outcome [19] 303582 0
IL-6 (Interleukin 6) (Venous blood sample-fasting)
Timepoint [19] 303582 0
Baseline (week 1), 3 months (post-baseline)
Secondary outcome [20] 303583 0
TNF alpha (Venous blood sample-fasting)
Timepoint [20] 303583 0
Week 1 (baseline), 3 months (post-baseline)

Eligibility
Key inclusion criteria
Aged 18 or over; have the capacity to consent to the study and to follow its instructions and procedures; fulfil the DSM-IV-TR diagnostic criteria for Major Depressive Disorder, Single Episode or Recurrent, as well as scoring 18 or over on the MADRS at the time of entry into the study. Antidepressant therapy is not an inclusion criterion; however, those on antidepressant therapy need to have been on the same treatment for at least two weeks prior to randomisation. Habitual diet quality will be assessed at screening using the validated Dietary Screening Tool (DST), and only those below the predetermined cutoff (less than 60= categorized as “at risk”) will be eligible for the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A concurrent diagnosis of bipolar I or II disorder; two or more failed trials of antidepressant therapy for the current major depressive episode; known or suspected clinically unstable systemic medical disorder; pregnancy or breastfeeding; commencement of new psychotherapy; current participation in an intervention targeting diet or exercise; a primary clinical diagnosis of a personality disorder or a current substance use disorder on structured interview.

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)
Patients will be recruited through various avenues, including
advertisements in local newspapers; flyers in medical waiting rooms, pharmacies and university campus; and direct contact with potential referral sources. Trial clinicians will contact all patients referred to the trial and screen for suitability through an initial telephone assessment and, where no obvious exclusion criteria are present, a subsequent face-to-face screening interview. Through this process, the trial clinicians will establish whether inclusion and exclusion criteria are satisfied, and perform the Structured Clinical Interview for DSM-IV (SCID). Participants will be randomly allocated to receive either the active or control condition in addition to any established
pharmacotherapy for their major depressive episode. Allocation will be concealed from Investigators and data collectors and performed via a central randomisation process by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using block randomization, participants will be randomly allocated using a computer generated randomisation table.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This is a 12-week, parallel group, single blind, randomised, controlled trial of an adjunctive dietary intervention in the treatment of moderate to severe depression.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2012
Actual
16/11/2013
Date of last participant enrolment
Anticipated
Actual
28/04/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
176
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5016 0
3220
Recruitment postcode(s) [2] 5017 0
3065

Funding & Sponsors
Funding source category [1] 284734 0
Government body
Name [1] 284734 0
National Health and Medical Research Council
Country [1] 284734 0
Australia
Primary sponsor type
Hospital
Name
Barwon Health
Address
Ryrie St
Geelong VIC
3220
Country
Australia
Secondary sponsor category [1] 283630 0
Hospital
Name [1] 283630 0
St Vincent's Health
Address [1] 283630 0
Victoria Parade
Fitzroy VIC
3065
Country [1] 283630 0
Australia
Other collaborator category [1] 260554 0
University
Name [1] 260554 0
Deakin University and Barwon Health
Address [1] 260554 0
Barwon Psychiatric Research Unit
Po Box 281
Ryrie St
Geelong
VIC 3220
Country [1] 260554 0
Australia
Other collaborator category [2] 260556 0
University
Name [2] 260556 0
University of Melbourne /St Vincent's Hospital
Address [2] 260556 0
St Vincent's Mental Health
Victoria Parade
Fitzroy
VIC 3065
Country [2] 260556 0
Australia
Other collaborator category [3] 260557 0
University
Name [3] 260557 0
Latrobe University
Address [3] 260557 0
Faculty of Health Sciences
Bundoora
Victoria 3086
Country [3] 260557 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286743 0
Barwon Health Human Research Ethics Committee
Ethics committee address [1] 286743 0
Ryrie Street
PO Box 281
Geelong VIC 3220
Ethics committee country [1] 286743 0
Australia
Date submitted for ethics approval [1] 286743 0
01/03/2012
Approval date [1] 286743 0
22/05/2012
Ethics approval number [1] 286743 0
HREC/12/VICBH/19
Ethics committee name [2] 286744 0
St Vincent's Health Human Research Ethics Committee
Ethics committee address [2] 286744 0
Victoria Parade
Fitzroy VIC
3065
Ethics committee country [2] 286744 0
Australia
Date submitted for ethics approval [2] 286744 0
01/03/2012
Approval date [2] 286744 0
01/08/2012
Ethics approval number [2] 286744 0
089/12

Summary
Brief summary
We aim to investigate the efficacy and cost-efficacy of dietary improvement in the treatment of Major Depressive Episodes (MDE) using a randomised controlled trial.
Trial website
Not yet available
Trial related presentations / publications
Not yet available
Public notes

Contacts
Principal investigator
Name 33795 0
A/Prof Felice Jacka
Address 33795 0
Barwon Psychiatric Research Unit Po Box 281 Geelong VIC 3220
Country 33795 0
Australia
Phone 33795 0
+61 3 52 603084
Fax 33795 0
Email 33795 0
[email protected]
Contact person for public queries
Name 17042 0
Adrienne O'neil
Address 17042 0
Barwon Psychiatric Research Unit
Po Box 281
Geelong VIC 3220
Country 17042 0
Australia
Phone 17042 0
+61 3 52 468170
Fax 17042 0
+61 3 52 465165
Email 17042 0
[email protected]
Contact person for scientific queries
Name 7970 0
A/Prof Felice Jacka
Address 7970 0
Barwon Psychiatric Research Unit
Po Box 281
Geelong VIC 3220
Country 7970 0
Australia
Phone 7970 0
+61 3 52 603084
Fax 7970 0
+61 3 52 465165
Email 7970 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIA randomised, controlled trial of a dietary intervention for adults with major depression (the “SMILES” trial): study protocol2013https://doi.org/10.1186/1471-244x-13-114
EmbaseA randomised controlled trial of dietary improvement for adults with major depression (the 'SMILES' trial).2017https://dx.doi.org/10.1186/s12916-017-0791-y
EmbaseA modified Mediterranean dietary intervention for adults with major depression: Dietary protocol and feasibility data from the SMILES trial.2018https://dx.doi.org/10.1080/1028415X.2017.1312841
EmbaseEconomic evaluation of a dietary intervention for adults with major depression (the "SMILES" trial).2018https://dx.doi.org/10.1186/s12889-018-5504-8
N.B. These documents automatically identified may not have been verified by the study sponsor.