Multi-country Project on the Role of Diet, Food-related Behavior, and Obesity in the Prevention of Depression

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.

Conditions

• Depression

Interventions

DIETARY_SUPPLEMENT

Multi-nutrient supplement

* Omega 3 fatty acids * Folic acid * Calcium * Selenium * Vitamin D3

BEHAVIORAL

Behavioral Activation

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.

OTHER

Placebo

Placebo pills identical in look and taste but including no active ingredients

Sponsors & Collaborators

• VU University of Amsterdam

  collaborator OTHER

• University of Exeter

  collaborator OTHER

• University of Leipzig

  collaborator OTHER

• University of the Balearic Islands

  lead OTHER

Principal Investigators

• Marjolein Visser, PhD · VU University of Amsterdam

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-07-31

Primary Completion

2016-10-31

Completion

2017-10-31

Countries

• Germany
• Netherlands
• Spain
• United Kingdom

Study Locations