MooDFOOD Trial Results
The MooDFOOD prevention trial is the first trial to directly test the impact of a food-related behavioural activation therapy and a unique multi-nutrient supplement (containing omega-3 fatty acids, selenium, vitamin D + calcium, on the prevention of depression. The trial found no evidence in primary analysis that food-related behavioural activation therapy or multi-nutrient supplementation reduced depressive symptoms, but secondary analysis found a significantly lower onset of major depressive disorder in participants who showed a greater adherence to the food- related behavioural activiation therapy. This therapy was delivered by psychologists and focused on promoting healthy dietary changes.
Importance of the trial: Effects of nutritional interventions on the prevention of major depressive disorder (MDD) are unknown.
Objective: To examine the effectiveness of two nutritional strategies (multi-nutrient supplementation, food-related behavioral activation (F-BA) therapy) and their combination to prevent a new MDD episode in overweight adults with subsyndromal depressive symptoms.
Design: 2x2 factorial randomized controlled trial, between 2015 and 2017.
Setting: Multicenter study (4 countries) in Europe
Participants: Overweight adults (body mass index 25-40kg/m2) aged 18-75years with elevated depressive symptoms (Patient Health Questionnaire-9 (PHQ-9) scores≥5) not meeting criteria for MDD episodes in the past 6 months. 5965 adults expressed interest to participate, and 1025 were randomized.
Interventions: Daily multi-nutrient supplements (1412mg omega-3 fatty acids, 30μg selenium, 400μg B-11 vitamin, and 20μg D-3 vitamin plus 100mg calcium) versus placebo (blinded), and/or 21 individual and group food-related behavioral activation (F-BA) sessions versus no F-BA (blinded to researchers), for one year.
Main outcome: Cumulative 1-year onset of MDD measured with the Mini International Neuropsychiatric Interview after 3, 6 and 12 months. Secondary mental health outcomes included time to MDD onset, depression symptoms (PHQ-9, Inventory of Depressive Symptomatology 30-SR), anxiety symptoms (Generalized Anxiety Disorder-7) and health utility (EQ-5D-5L).
Results: Mean age was 46.5years, mean BMI was 31.4kg/m2 and 75% were female. 779 (76%) participated at 12 months. 105 (10%) developed MDD. Logistic regression using effect–coded intervention variables (-1,1) indicated that neither supplements (odds ratio (OR)=1.06; 95% confidence interval (CI)=0.87-1.29), F-BA (OR=0.93; 95%CI=0.76-1.13), nor their combination (OR=0.93; 95%CI=0.76-1.14, p for interaction=0.48) affected MDD onset. No beneficial intervention effects were observed for secondary outcomes, except for F-BA on 12-month follow-up anxiety symptoms. In complier average causal effect analysis accounting for a predefined minimum therapeutic dose, F-BA reduced MDD onset (OR=0.78; 95%CI=0.64-0.95).
Conclusions and Relevance: Multi-nutrient supplements and/or F-BA had no effect on prevention of MDD, time to MDD onset, depressive and anxiety symptoms, and utility in overweight adults with subsyndromal depressive symptoms. Only F-BA reduced anxiety symptoms after 12-months. F-BA prevented MDD onset when accounting for compliance, suggesting that with sufficient dose, it might prevent depression. As placebo outperformed multi-nutrient supplements, supplements are not indicated in this population.
Trial registration: https://www.clinicaltrials.gov/ct2/show/NCT02529423. August 2015.