Multi-country Project on the Role of Diet, Food-related Behavior, and Obesity in the Prevention of Depression
Multi-country Project on the Role of Diet, Food-related Behavior, and Obesity in the Prevention of Depression
NCT ID: NCT02529423 Phase: NA Status: COMPLETED Enrollment: 1000 Completion: 2017-10
Conditions
Depression
Interventions
Multi-nutrient supplement, Behavioral Activation, Placebo
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:
- Control group (daily placebo supplements)
- Multi-nutrient supplementation group (daily multi-nutrient supplement)
- Food-related behavioural change group (food-related behavioural activation focusing on improving overall diet + placebo supplements)
- 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.
Primary Outcome
Cumulative incidence of Major depressive Disorder