Cited by 128Treatment of Major DepressionNutritional Studies and DietFatty Acid Research and Health

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Effect of Multinutrient Supplementation and Food-Related Behavioral Activation Therapy on Prevention of Major Depressive Disorder Among Overweight or Obese Adults With Subsyndromal Depressive Symptoms: The MooDFOOD Randomized Clinical Trial

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Bot, Mariska, Brouwer, Ingeborg A., Roca, Miquel, Kohls, Elisabeth, Penninx, Brenda W. J. H., Watkins, Ed, van Grootheest, Gerard, Cabout, Mieke, Hegerl, Ulrich, Gili, Margalida, Owens, Matthew, Visser, Marjolein, for the MooDFOOD Prevention Trial Investigators·2019·JAMA

DOI 10.1001/jama.2019.0556PMC PMC6439597

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Abstract

Importance: Effects of nutritional interventions on the prevention of major depressive disorder (MDD) in overweight adults are unknown. Objective: To examine the effect of 2 nutritional strategies (multinutrient supplementation, food-related behavioral activation therapy) and their combination for prevention of a new MDD episode in overweight adults with subsyndromal depressive symptoms. Design, Setting, and Participants: This multicenter 2 × 2 factorial randomized clinical trial included overweight adults (body mass index, 25-40) with elevated depressive symptoms (Patient Health Questionnaire-9 [PHQ-9] scores ≥5) and no MDD episode in the past 6 months from 4 European countries. A total of 1025 adults were randomized (July 30, 2015-October 12, 2016) and followed up for 1 year (October 13, 2017). Interventions: Daily multinutrient supplements (1412-mg omega-3 fatty acids, 30-μg selenium, 400-μg folic acid, and 20-μg vitamin D3 plus 100-mg calcium) vs placebo and 21 individual or group therapy sessions vs none (blinded to researchers) for 1 year. Participants were allocated to placebo without therapy (n = 257), placebo with therapy (n = 256), supplements without therapy (n = 256), and supplements with therapy (n = 256). Main Outcome and Measures: Cumulative 1-year onset of MDD via the Mini International Neuropsychiatric Interview at 3, 6, and 12 months. Logistic regression using effect-coded variables (-1 indicating control, 1 indicating intervention) evaluated intervention effects both individually and in combination (interaction) on MDD onset. Results: Among 1025 participants (mean age, 46.5 years; 772 women [75%]; mean BMI, 31.4), 779 (76%) completed the trial. During the 12-month follow-up, 105 (10%) developed MDD: 25 (9.7%) patients in the placebo without therapy, 26 (10.2%) in the placebo with therapy, 32 (12.5%) in the supplement without therapy, and 22 (8.6%) in the supplement with therapy group. None of the treatment strategies affected MDD onset. The odds ratio (OR) for supplements was 1.06 (95% CI, 0.87-1.29); for therapy, 0.93 (95% CI, 0.76-1.13); and for their combination, 0.93 (95% CI, 0.76-1.14; P for interaction, .48). One person in the supplementation with therapy group, died. Twenty-four patients in each of the placebo groups and 24 patients in the supplementation with therapy group were hospitalized, and 26 patients in the supplementation-only group were hospitalized. Conclusions and Relevance: Among overweight or obese adults with subsyndromal depressive symptoms, multinutrient supplementation compared with placebo and food-related behavioral activation therapy compared with no therapy did not reduce episodes of major depressive disorder during 1 year. These findings do not support the use of these interventions for prevention of major depressive disorder. Trial registration: ClinicalTrials.gov Identifier: NCT02529423.

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Authors: Bot, M., Brouwer, I. A., Roca, M., Kohls, E., Penninx, B. W. J. H., Watkins, E., van Grootheest, G., Cabout, M., Hegerl, U., Gili, M., Owens, M., Visser, M., & for the MooDFOOD Prevention Trial Investigators
Affiliations: Amsterdam Public Health (NL)
Health Research Institute of the Balearic Islands (ES)
Leipzig University (DE)
Department of Psychology, University of Exeter, Exeter, United Kingdom
Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health research institute, GGZ inGeest Specialized Mental Health Care, Amsterdam, the Netherlands
University of Exeter (GB)
Corresponding author: Visser, Marjolein
ORCID: Bot, Mariska
Brouwer, Ingeborg A.
Roca, Miquel
Kohls, Elisabeth
Penninx, Brenda W. J. H.
Hegerl, Ulrich
Gili, Margalida
Owens, Matthew
Visser, Marjolein
Venue: JAMA
Publisher: American Medical Association (AMA)
Published: 2019-03-05
Volume: 321
Issue: 9
Pages: 858
ISSN: 0002-9955 (ISSN-L)
0098-7484
DOI: 10.1001/jama.2019.0556
PMC: PMC6439597
OpenAlex: W2919675892
Cited by: 128
References: 46
Citations by year: 2026: 13 · 2025: 11 · 2024: 14 · 2023: 17 · 2022: 21 · 2021: 16 · 2020: 21 · 2019: 15
FWCI: 11.31
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: JAMA (publishedVersion)
Europe PMC (PubMed Central) (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Pure Amsterdam UMC (publishedVersion, other-oa)
VU Research Portal (publishedVersion, other-oa)
Open Research Exeter (University of Exeter) (acceptedVersion)
Figshare (submittedVersion)
Amsterdam UMC (VU Amsterdam) - Institutional Repository (submittedVersion)
Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
Data Archiving and Networked Services (DANS) (submittedVersion)
Funders: National Institute for Health and Care Research (613598)
University of Exeter
European Commission (613598)
GGZ inGeest
NIHR Exeter Clinical Research Facility
Topics: Health Sciences › Medicine › Pharmacology (medical) › Treatment of Major Depression
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Nutritional Studies and Diet
Health Sciences › Nursing › Nutrition and Dietetics › Fatty Acid Research and Health
Keywords: subsyndromal depressive symptoms, overweight adults, obesity, omega-3 fatty acids, selenium, folic acid, vitamin D3, calcium, depression onset, dietary intervention, psychotherapy, factorial design, depression recurrence prevention, physical activity
MeSH terms: Adult, Analysis of Variance, Behavior Therapy, Combined Modality Therapy, Major Depressive Disorder, Depressive Disorder, Major, Female, Follow-Up Studies, Humans, Male, Middle Aged, Obesity, Psychotherapy, Group, Treatment Failure, Dietary Supplements, Overweight

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Effect of Multinutrient Supplementation and Food-Related Behavioral Activation Therapy on Prevention of Major Depressive Disorder Among Overweight or Obese Adults With Subsyndromal Depressive Symptoms: The MooDFOOD Randomized Clinical Trial

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