Evidence map›Paper›PMID 28137247›Full record

Trial reportBMC medicine2017

A randomised controlled trial of dietary improvement for adults with major depression (the 'SMILES' trial).

Felice N Jacka, Adrienne O'Neil, Rachelle Opie, Catherine Itsiopoulos, Sue Cotton, Mohammedreza Mohebbi, David Castle, Sarah Dash, Cathrine Mihalopoulos, Mary Lou Chatterton and 4 more

Erratum issuedAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 490 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
490citing papers in PubMed, 9 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

490 citing papers in PubMed, 9 syntheses or guidelines pooled it.

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  19. Role of Private Practice Dietitians in Working With People With Mental Illness: A Constructivist-Interpretivist Qualitative Interview Study.Journal of human nutrition and dietetics : the official journal of the British Dietetic Association · 2026
    Article
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430 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Felice N JackaIMPACT Strategic Research Centre, Deakin University, Geelong, VIC, Australia. f.jacka@deakin.edu.au.
Adrienne O'NeilIMPACT Strategic Research Centre, Deakin University, Geelong, VIC, Australia.
Rachelle OpieSchool of Allied Health, La Trobe University, Melbourne, VIC, Australia.
Catherine ItsiopoulosSchool of Allied Health, La Trobe University, Melbourne, VIC, Australia.
Sue CottonOrygen, The National Centre of Excellence in Youth Mental Health, Parkville, VIC, Australia.
Mohammedreza MohebbiIMPACT Strategic Research Centre, Deakin University, Geelong, VIC, Australia.
David CastleDepartment of Psychiatry, University of Melbourne, Melbourne, VIC, Australia.
Sarah DashIMPACT Strategic Research Centre, Deakin University, Geelong, VIC, Australia.
Cathrine MihalopoulosCentre for Population Health Research, Deakin University, Geelong, VIC, Australia.
Mary Lou ChattertonCentre for Population Health Research, Deakin University, Geelong, VIC, Australia.
Laima BrazionisSchool of Allied Health, La Trobe University, Melbourne, VIC, Australia.
Olivia M DeanIMPACT Strategic Research Centre, Deakin University, Geelong, VIC, Australia.
Allison M HodgeCancer Epidemiology and Intelligence Division, Cancer Council Victoria, Carlton, VIC, Australia.
Michael BerkIMPACT Strategic Research Centre, Deakin University, Geelong, VIC, Australia.

Funding

NICHD NIH HHS N01 AA021004
6 · The paper itself

Abstract

backgroundThe possible therapeutic impact of dietary changes on existing mental illness is largely unknown. Using a randomised controlled trial design, we aimed to investigate the efficacy of a dietary improvement program for the treatment of major depressive episodes.

methods'SMILES' was a 12-week, parallel-group, single blind, randomised controlled trial of an adjunctive dietary intervention in the treatment of moderate to severe depression. The intervention consisted of seven individual nutritional consulting sessions delivered by a clinical dietician. The control condition comprised a social support protocol to the same visit schedule and length. Depression symptomatology was the primary endpoint, assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS) at 12 weeks. Secondary outcomes included remission and change of symptoms, mood and anxiety. Analyses utilised a likelihood-based mixed-effects model repeated measures (MMRM) approach. The robustness of estimates was investigated through sensitivity analyses.

resultsWe assessed 166 individuals for eligibility, of whom 67 were enrolled (diet intervention, n = 33; control, n = 34). Of these, 55 were utilising some form of therapy: 21 were using psychotherapy and pharmacotherapy combined; 9 were using exclusively psychotherapy; and 25 were using only pharmacotherapy. There were 31 in the diet support group and 25 in the social support control group who had complete data at 12 weeks. The dietary support group demonstrated significantly greater improvement between baseline and 12 weeks on the MADRS than the social support control group, t(60.7) = 4.38, p < 0.001, Cohen's d = -1.16. Remission, defined as a MADRS score <10, was achieved for 32.3% (n = 10) and 8.0% (n = 2) of the intervention and control groups, respectively (χ

conclusionsThese results indicate that dietary improvement may provide an efficacious and accessible treatment strategy for the management of this highly prevalent mental disorder, the benefits of which could extend to the management of common co-morbidities.

trial registrationAustralia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000251820 . Registered on 29 February 2012.

Indexed as

AdultAustraliaComorbidityFemaleHumansLikelihood FunctionsMajor Depressive DisorderMaleMiddle AgedNew ZealandSingle-Blind MethodTreatment OutcomeDepressionDietDieteticsMajor depressive disorderNutritionRandomised controlled trial

Identifiers

PMID28137247
PMCPMC5282719

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.