Multi-country Project on the Role of Diet, Food-related Behavior, and Obesity in the Prevention of Depression
Condition: Depression
MeSH terms: Obesity; Depression; Depressive Disorder
Study type: Interventional

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.
    

Detailed description: 
      Research has shown that nutrition may be an important way to promote mood and health, but so
      far researchers do not know which aspects of nutrition and behaviour are most important. The
      study is collaboration between the United Kingdom, Germany, Netherlands and Spain, funded by
      the European Commission. The trial compares different nutritional and lifestyle strategies
      that might promote mood and health in people who are overweight. For this purpose the design
      is a two-by-two factorial randomized controlled prevention trial with two intervention
      conditions: a multi-nutrient supplement and a food-related behavioural change (FBC)
      intervention. A total of four intervention groups are created: control condition (placebo, no
      FBC intervention), placebo with FBC intervention, multinutrient supplement with no FBC
      intervention, multi-nutrient supplement with FBC intervention.Recruitment: 1000 subjects will
      be recruited at four study sites in different EU countries (United Kingdom, Germany,
      Netherlands and Spain). Participants will be randomized with equal probability to the four
      intervention arms using a blind computerised randomization procedure.The multinutrient
      supplement and the placebo needs to taken every day during one year. The multinutrient
      supplement pill will contain omega 3 fatty acids, vitamin D, folic acid, selenium and
      calcium. FBC will consist of 21 behavioral activation sessions to adopt healthy diet
      behaviours that are known to explain the association between food intake and depression.

      Follow-up assessment will be conducted by researchers unaware of the randomization status at
      3, 6, and 12 months for primary and secondary outcomes. 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 (following the 2x2 factorial design of the trial). Per-protocol analyses
      and mediation analyses will be conducted to examine to what extent compliance and potential
      mediating mechanisms explain the impact on the primary and secondary endpoints. Data
      collection at the different sites will be conducted according to the strictest European code
      of ethics and conduct as well as codes for Good Clinical Practice, and local/national and
      international laws and regulations, including the Declaration of Helsinki. In a random
      subsample of trial participants (n=50 per intervention arm) blood samples will be collected
      at baseline, and after 3 and 12 months to measure blood levels of the nutrients provided with
      the multi-nutrient supplement.
    

Intervention name(s): Multi-nutrient supplement; Behavioral Activation; Placebo
Intervention type(s): Dietary Supplement; Behavioral; Other
Intervention description(s): 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
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: food intake; food-related behaviour; obesity; socioeconomic environment; depression; nutritional strategies