At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multi-country cOllaborative Project on the rOle of Diet, FOod-related Behaviour, and Obesity in the Prevention of Depression (MoodFOOD)
In Brief
A clinical study evaluating Multi-nutrient supplement, Behavioral Activation, and 1 other intervention for Depression. Completed, enrolled 1,000 participants across 4 sites in 4 countries.
Detailed Summary
The study examines the feasibility and effectiveness of two different nutritional strategies (multi-nutrient supplement and food-related behavioural change) to prevent depression in high-risk overweight European Union citizens. Interventions will last 12 months. Design is a two-by-two factorial randomized controlled prevention trial with four intervention groups: 1. Control group (daily placebo supplements) 2. Multi-nutrient supplementation group (daily multi-nutrient supplement) 3. Food-related behavioural change group (food-related behavioural activation focusing on improving overall diet + placebo supplements) 4. Multi-nutrient supplementation + food-related behavioural activation group (daily multi-nutrient supplement + food-related behavioural activation focusing on improving overall diet). Follow-up assessment will be conducted at 3, 6, and 12 months for primary and secondary endpoints, and during intervention for compliance, adverse events and mediating variables.Data will first be analyzed according to the intention-to-treat principle, using (mixed model) analysis of covariance with primary and secondary endpoints, testing for the effects of the two nutritional strategies separately as well as combined.
Study Details
Timeline
Interventions
* Omega 3 fatty acids * Folic acid * Calcium * Selenium * Vitamin D3
21 sessions (15 individual sessions and 6 group sessions) The intervention will include detailed analysis of each individual's behavior to determine idiosyncratic triggers and functions of unhelpful (e.g., mood-related snacking) and helpful food-related behavior, thereby, to reinforce helpful behaviors and to implement effective alternatives to unhelpful behaviors, building on behavioural approaches proven effective in depression.
Placebo pills identical in look and taste but including no active ingredients