Acceptability and feasibility of two interventions in the MooDFOOD Trial: a food-related depression prevention randomised controlled trial in overweight adults with subsyndromal symptoms of depression

Matthew Owens, Edward Watkins, Mariska Bot, Ingeborg Annemarie Brouwer, Miquel Roca, Elisabeth Kohls, Brenda Penninx, Gerard van Grootheest, Mieke Cabout, Ulrich Hegerl, Margalida Gili, Marjolein Visser, MooDFOOD Prevention Trial Investigators, Bep Verkerk, Nadine Paans, Carisha Thesing, Deborah Gibson-Smith, Melany Horsfall, Lena Weiss, Amy Romijn, Hannah Bunce, Owain Winfield, Harriet Bunker-Smith, Fern Durbridge, Caterina Versari Molinares, Atikah Sapar, Miquel Tortella, Clara Homar Covas, M Angeles Pérez-Ara, Adoración Castro Gracia, José Luis Reig, Jana Hoesel, Ezgi Dogan, Sabrina Baldofski, Nicole Mauche, Matthew Owens, Edward Watkins, Mariska Bot, Ingeborg Annemarie Brouwer, Miquel Roca, Elisabeth Kohls, Brenda Penninx, Gerard van Grootheest, Mieke Cabout, Ulrich Hegerl, Margalida Gili, Marjolein Visser, MooDFOOD Prevention Trial Investigators, Bep Verkerk, Nadine Paans, Carisha Thesing, Deborah Gibson-Smith, Melany Horsfall, Lena Weiss, Amy Romijn, Hannah Bunce, Owain Winfield, Harriet Bunker-Smith, Fern Durbridge, Caterina Versari Molinares, Atikah Sapar, Miquel Tortella, Clara Homar Covas, M Angeles Pérez-Ara, Adoración Castro Gracia, José Luis Reig, Jana Hoesel, Ezgi Dogan, Sabrina Baldofski, Nicole Mauche

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.

Keywords: clinical trials; depression & mood disorders; mental health; nutrition & dietetics; preventive medicine.

Conflict of interest statement

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.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

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