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

Study answer

What this study found

Primary outcome: MADRS score improved more with the dietary intervention than control at 12 weeks (mean change from baseline to 12 weeks: DS −11.3; SS −4.2; between-group difference 7.1 points; t(60.7)=4.38; p<0.001). Remission (MADRS <10) reached by 32.3% in DS vs 8.0% in SS; number needed to treat = 4.1 (95% CI 2.3-27.8). Sensitivity analyses showed results robust to missing data. Secondary outcomes: greater improvements in HADS-D and HADS-A and CGI-I in DS; ModiMedDiet score rose more in DS, indicating better adherence; BMI and overall well-being (WHO-5) did not differ; some biomarkers…

Study & population

12-week, parallel-group, single-blind randomized controlled trial conducted at two Australian sites (Geelong and Melbourne).

Intervention

ModiMedDiet dietary program for 12 weeks: seven 60-minute sessions of personalized dietary support delivered by an Accredited Practising Dietitian; sessions: first four weekly, last three every two weeks; diet emphasizes a ModiMedDiet (modified Mediterranean) pattern focusing on 12 key food groups (whole grains 5-8…

Key limitation

Small sample size and underpower relative to planned sample; short 12-week duration; differential dropout between groups (more completers in dietary group); lack of complete blinding and potential expectation biases; possible selection bias and limited generalisability to broader populations; concomitant therapies…

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Original abstract