MooDFOOD
Research type
Research Study
Full title
A Multi-Country Factorial Randomised Controlled Trial of Food-related Behaviour Change and Multi-nutrient Supplementation on the Prevention of Depression.
IRAS ID
182284
Contact name
Ed Watkins
Contact email
Sponsor organisation
University of Exeter
Duration of Study in the UK
4 years, 0 months, 30 days
Research summary
MooDFOOD is a Multi-country collaborative project on the role of diet, food-related behaviour, and obesity in the prevention of depression, approved by the European Commission at the 7th Framework Programme. Depression is one of the most prevalent, severe and disabling disorders in the EU and places a heavy burden on individuals and families. A large and increasing proportion of the global population is overweight which increases depression risk. Improving food-related behaviour and nutrient status offer opportunities to prevent depression, particularly for people prone to being overweight.
This multi-country randomised controlled trial involves a further 3 sites in addition to the UK (Germany, the Netherlands and Spain) and its aim is to assess the long-term effect of nutritional supplementation and dietary behaviour change on the prevention of depression in an at-risk group of adults who are overweight with elevated, pre-clinical symptoms of depression.
The trial has 1-year duration and aims to recruit a total of 1000 participants (18-75 years old) across all sites (i.e. 250 in the UK) who will have some symptoms of depression (not a clinical diagnosis of major depression) and will be overweight (measured by Body Mass Index = 25-40). Participants will be randomly allocated to one of the following four conditions, or arms to the trial:
1) Multi-nutrient supplementation group (taking multi-nutrient supplements daily)
2) Control group (taking placebo supplements daily)
3) Food-related behavioural change group (behavioural change intervention + placebo supplements)
4) Food-related behavioural change group (behavioural change intervention + multi-nutrient supplements)The primary outcome is the relative incidence of major depressive disorder (MDD) in each trial arm. Follow-up assessment of MDD will occur at 3, 6 and 12 months after baseline.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
15/SW/0153
Date of REC Opinion
3 Aug 2015
REC opinion
Further Information Favourable Opinion