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Abstract
Objectives We report on the acceptability, feasibility, dose-response relationship and adherence of two nutritional strategies to improve mood (multinutrient supplements; food-related behavioural activation (F-BA)) studied in a randomised controlled depression prevention trial (the Multi‐country cOllaborative project on the rOle of Diet, Food‐related behaviour, and Obesity in the prevention of Depression (MooDFOOD) Trial). We also assessed baseline determinants of adherence and assessed whether better adherence resulted in lower depressive symptoms.
Design Randomised controlled trial with a 2×2 factorial design conducted between 2015 and 2017.
Setting Germany, the Netherlands, UK and Spain.
Participants Community sample of 1025 overweight adults with elevated depressive symptoms without a current episode of major depressive disorder. Main eligibility criteria included age (18–75 years), being overweight or obese, and having at least mild depressive symptoms, shown by a Patient Health Questionnaire Score of ≥5. A total of 76% of the sample was retained at the 12-month follow-up.
Interventions Daily nutritional supplements versus pill placebo or an F-BA therapy, delivered in individual and group sessions versus no behavioural intervention over a 1-year period.
Primary and secondary outcome measures Primary outcome: self-reported acceptability of the interventions. Secondary outcomes: adherence and self-reported depressive symptoms.
Results Most participants reported that the F-BA was acceptable (83.61%), feasible to do (65.91%) and would recommend it to a friend (84.57%). Individual F-BA sessions (88.10%) were significantly more often rated as positive than group F-BA sessions (70.17%) and supplements (28.59%). There were statistically significant reductions in depressive symptoms for those who both adhered to the F-BA intervention and had a history of depression (B=−0.08, SE=0.03, p=0.012) versus those who had no history of depression. Supplement intake had no effect on depressive symptoms irrespective of adherence.
Conclusions F-BA may have scope for development as a depression prevention intervention and public health strategy but further refinement and testing are needed.
Trial registration number NCT02529423.
- depression & mood disorders
- nutrition & dietetics
- preventive medicine
- mental health
- clinical trials
This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
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Footnotes
Collaborators The MooDFOOD Prevention Trial Investigators: Bep Verkerk, post-BSc (data manager, GGZ inGeest Specialized Mental Health Care, Amsterdam, the Netherlands), Nadine Paans, MSc (field center therapist and research assistant, Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands), Carisha Thesing, MSc (field center therapist, Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands), Deborah Gibson-Smith, MSc (field center research assistant, Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands), Melany Horsfall, MSc (field center coordinator, GGZ inGeest Specialized Mental Health Care, Amsterdam, the Netherlands), Lena Weiss, MSc (field center research assistant, Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands), Amy Romijn, PhD (field postdoctoral research associate, University of Exeter, Exeter, United Kingdom), Hannah Bunce, MSc (field center associate research fellow), Owain Winfield, BSc (research therapist, University of Exeter, Exeter, United Kingdom), Harriet Bunker-Smith, MSc (field center associate research fellow, University of Exeter, Exeter, United Kingdom), Fern Durbridge, BSc (field center associate research fellow, University of Exeter, Exeter, United Kingdom), Caterina Versari Molinares, MSc (research intern, University of Exeter, Exeter, United Kingdom), Atikah Sapar, BSc (research intern, University of Exeter, Exeter, United Kingdom), Miquel Tortella, PhD (field center coinvestigator, UIB, Palma de Mallorca, Spain), Clara Homar Covas, MSc (field center research and therapist, UIB, Palma de Mallorca, Spain), M. Angeles Pérez-Ara, PhD (field center research assistant, UIB, Palma de Mallorca, Spain), Adoración Castro Gracia, MSc (field center research assistant, UIB, Palma de Mallorca, Spain), José Luis Reig, MSc (field center therapist, UIB, Palma de Mallorca, Spain), Jana Hoesel (field center study nurse, ULEI, Leipzig, Germany), Ezgi Dogan, MD (field center research fellow, ULEI, Leipzig, Germany), Sabrina Baldofski, PhD (field center therapist, ULEI, Leipzig, Germany), and Nicole Mauche, MSc (field center therapist).
Contributors MO, EW were the lead authors of the manuscript and MO analysed and interpreted the data with EW. MV and IAB obtained funding for the MooDFOOD project, designed the MooDFOOD prevention trial and together with MC coordinated the MooDFOOD project. BP, MB and EW contributed to the design of the MooDFOOD prevention trial. EW led the development and training of the MooDFOOD food-related behavioural change intervention. EK and UH coordinated the recruitment, interventions and follow-ups at the trial centre in Germany, University Leipzig. BP and MB coordinated the recruitment, interventions and follow-ups at the trial centre in the Netherlands, VU University Medical Center Amsterdam. EW and MO coordinated the recruitment, interventions and follow-ups at the trial centre in the UK, University of Exeter. MR and MG coordinated the recruitment, interventions and follow-ups at the trial centre in Spain, University of Balearic Islands. GvG set up the logistics for the trial’s data collection. All authors contributed to the writing of the manuscript and approved the final version. Please, see www.moodfood-vu.eu for a complete list of the MooDFOOD prevention trial Investigators.
Funding This work was supported by the European Union FP7 MooDFOOD Project ‘Multi-country collaborative project on the role of Diet, food related behaviour, and Obesity in the prevention of Depression’ (grant agreement no. 613598). This work is supported in the UK by the National Institute for Health Research (NIHR), through the Primary Care Research Network and the NIHR Exeter Clinical Research Facility.
Competing interests MR reported receiving grants from the European Union and research funding from Janssen and Lundbeck outside the submitted work. BP reported receiving grants from Janssen Research and Boehringer Ingelheim. EW reported receiving royalties for a therapy manual in Behavioural Activation/Cognitive Behavioural Therapy from Guilford Press; and honorarium for running workshops in his rumination-focused cognitive behavioural therapy from different national cognitive behavioural therapy organisations worldwide. UH reported receiving a honorarium for scientific talks from Lundbeck, Janssen Pharmaceutica, and Servier, and a research grant from Medice outside the submitted work.
Patient consent for publication Not required.
Ethics approval The trial received approval from the local regional ethics committees.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request. Data collected for this study will be made available after approval of an analysis plan by the MooDFOOD Trial publication committee. How to access data: Data can be accessed at https://www.moodfood-vu.eu/ or moodfood.po@vu.nl. Who can access the data: researchers whose proposed use of the data has been approved. Types of analyses: for a specified purpose. Mechanisms of data availability: after approval of a proposal. Any additional restrictions: data can only be used for the analysis outlined in the approved analysis plan.