Prevention of depression through nutritional strategies in high-risk persons: rationale and design of the MooDFOOD prevention trial

BMC Psychiatry

Study Protocol

Ingeborg A. Brouwer¹  Mieke Cabout¹  Marjolein Visser²  Elisabeth Kohls³  Ulrich Hegerl³  Ed Watkins⁴  Matthew Owens⁴  Gerard van Grootheest⁵  Mariska Bot⁵  Brenda W. Penninx⁵  Miquel Roca⁶  Margalida Gili⁶ 

[1] Department of Health Sciences and the EMGO+ Institute for Health and Care Research, Faculty of Earth and Life Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands;Department of Health Sciences and the EMGO+ Institute for Health and Care Research, Faculty of Earth and Life Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands;Department of Internal Medicine, Nutrition and Dietetics, VU University Medical Center, Amsterdam, The Netherlands;Department of Psychiatry and Psychotherapy, University Leipzig, Medical Faculty, Leipzig, Germany;Department of Psychology, University of Exeter, Exeter, UK;GGZ inGeest and Department of Psychiatry, EMGO+ Institute for Health and Care Research, VU University Medical Center, Amsterdam, The Netherlands;Institut Universitari d’ Investigació en Ciències de la Salut (IUNICS/IDISPA), Rediapp, University of Balearic Islands, Carretera de Valldemosssa km 7,5, 07071, Palma de Mallorca, Spain;

关键词: Depression;    Overweight;    Multi-nutrient supplements;    Diet;    Food behavioral activation;    Food behavior;    Prevention;    Randomized controlled trial;   

DOI  :  10.1186/s12888-016-0900-z

 received in 2016-05-23, accepted in 2016-06-02,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundObesity and depression are two prevalent conditions that are costly to individuals and society. The bidirectional association of obesity with depression, in which unhealthy dietary patterns may play an important role, has been well established. Few experimental studies have been conducted to investigate whether supplementing specific nutrients or improving diet and food-related behaviors can prevent depression in overweight persons.Method/DesignThe MooDFOOD prevention trial examines the feasibility and effectiveness of two different nutritional strategies [multi-nutrient supplementation and food-related behavioral change therapy (FBC)] to prevent depression in individuals who are overweight and have elevated depressive symptoms but who are not currently or in the last 6 months meeting criteria for an episode of major depressive disorder (MDD). The randomized controlled prevention trial has a two-by-two factorial design: participants are randomized to daily multi-nutrient supplement (omega-3 fatty acids, calcium, selenium, B-11 vitamin and D-3 vitamin) versus placebo, and/or FBC therapy sessions versus usual care. Interventions last 12 months. In total 1000 participants aged 18–75 years with body mass index between 25–40 kg/m2 and with a Patient Health Questionnaire-9 score ≥ 5 will be recruited at four study sites in four European countries. Baseline and follow-up assessments take place at 0, 3, 6, and 12 months. Primary endpoint is the onset of an episode of MDD, assessed according to DSM-IV based criteria using the MINI 5.0 interview. Depressive symptoms, anxiety, food and eating behavior, physical activity and health related quality of life are secondary outcomes. During the intervention, compliance, adverse events and potentially mediating variables are carefully monitored.DiscussionThe trial aims to provide a better understanding of the causal role of specific nutrients, overall diet, and food-related behavior change with respect to the incidence of MDD episodes. This knowledge will be used to develop and disseminate innovative evidence-based, feasible, and effective nutritional public health strategies for the prevention of clinical depression.Trial registrationClinicalTrials.gov. Number of identification: NCT02529423. August 2015.

【 授权许可】

CC BY   
© The Author(s). 2016