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Participants had to be readily available for a 12-week period and have the ability to eat foods as prescribed, without religious, medical, socio-cultural or political factors precluding participation or adherence to the diet.Participants were ineligible if they had: (1) a concurrent diagnosis of bipolar I or II disorder; (2) two or more failed trials of antidepressant therapy for the current MDE; (3) known or suspected clinically unstable systemic medical disorder; (4) pregnancy; (5) commencement of new psychotherapy or pharmacotherapy within the preceding 2 weeks; (6) severe food allergies, intolerances or aversions; (7) current participation in an intervention targeting diet or exercise; (8) a primary clinical diagnosis of a personality disorder and/or a current substance use disorder.More recently, a systematic review confirmed relationships between unhealthful dietary patterns, characterised by higher intakes of foods with saturated fat and refined carbohydrates, and processed food products, and poorer mental health in children and adolescents [], the field of research focusing on the relationships between overall dietary quality and mental disorders is new and has thus far been largely limited to animal studies and observational studies in humans.Thus, whilst the existing observational data support a causal relationship between diet quality and depression on the basis of the Bradford Hill criteria []), randomised controlled trials are required to test causal relationships and identify whether or not dietary change can improve mental health in people with such conditions.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.

A sensitivity analysis, testing departures from the missing at random (MAR) assumption for dropouts, indicated that the impact of the intervention was robust to violations of MAR assumptions.

In this trial, Supporting the Modification of lifestyle In Lowered Emotional States (SMILES), we hypothesised that structured dietary support, focusing on improving diet quality using a modified Mediterranean diet model, would be superior to a social support control condition (befriending) in reducing the severity of depressive symptomatology.]).

This trial was registered in the Australia and New Zealand Clinical Trials Register (ANZCTR): (ACTRN12612000251820) prior to commencing recruitment.

These 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. Although there are many versions of a ‘healthful diet’ in different countries and cultures, the available evidence from observational studies suggests that diets higher in plant foods, such as vegetables, fruits, legumes and whole grains, and lean proteins, including fish, are associated with a reduced risk for depression, whilst dietary patterns that include more processed food and sugary products are associated with an increased risk of depression [].

Whilst cognisant of the limitations of observational data, these associations are usually observed to be independent of socioeconomic status, education and other potentially confounding variables and not necessarily explained by reverse causality (see, e.g. Recently, a meta-analysis confirmed that adherence to a ‘healthful’ dietary pattern, comprising higher intakes of fruit and vegetables, fish and whole grains, was associated with a reduced likelihood of depression in adults [].

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We conducted a systematic review and identified a number of interventions with a dietary change component that had examined mental health-related outcomes [].

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