A 6-month randomised controlled trial investigating effects of Mediterranean-style diet and fish oil supplementation on dietary behaviour change, mental and cardiometabolic health and health-related quality of life in adults with depression (HELFIMED): study protocol

Abstract

Background: Modern diets, characterised by excess consumption of processed foods, are accompanied by an epidemic of chronic diseases. Cardiovascular disease and depression carry a large burden of disease and often occur together. Poor dietary patterns have been identified as an independent risk factor for depression while healthy diets with minimally processed food are protective. Traditional Mediterranean diets have been shown to reduce risk of cardiovascular disease; however there is a need for clinical trials in people with depression. This paper reports the study protocol of a Mediterranean-style diet intervention conducted in adults with self-reported depression.

A Mediterranean-style dietary intervention supplemented with fish oil improves diet quality and mental health in people with depression: A randomized controlled trial (HELFIMED)

“…The detailed study protocol is published elsewhere. 18 The trial was registered with the Australian New Zealand Clinical Trials Register (ACTRN12614000438651).…”

“…16 Secondary analysis from the PREDIMED study showed some trends for reduced risk of depression in the MedDiet group 17 but was not powered for this outcome. We are aware of only two dietary RCTs in people with depression; this study 18 and another Australian study which was recently completed. 19 Changing established dietary behaviours is challenging, and this is attributed to factors such an obesogenic environment 20 and the addictive nature of high-fat high-sugar foods.…”

Cost effectiveness and cost-utility analysis of a group-based diet intervention for treating major depression – the HELFIMED trial

“…HELFIMED recruited adults with major depression [21], based on a depression diagnosis or at least moderate depressive symptoms for two+ months based on the depression subscale of the Depression Anxiety Stress Scale DASS-21 [22]. At baseline, over 80% of eligible participants reported depressive symptoms in the 'extremely severe' category.…”

“…The HELFIMED study protocol describing recruitment strategy, diet and social group conditions and measured outcomes has been published elsewhere [21]. Outcomes were measured at 3-months (end of intervention) and at 6-months (3-month posttrial follow-up).…”

“…Participants who had recently commenced a treatment had their baseline assessment delayed by one month. Any participants who commenced a new treatment after trial enrolment (n = 5) was excluded from outcome assessment [13,21].…”