Clinical trial NCT02529423: Multi-country Project on the Role of Diet, Food-related Behavior, and Obesity in the Prevention of Depression
Official title: Multi-country cOllaborative Project on the rOle of Diet, FOod-related Behaviour, and Obesity in the Prevention of Depression (MoodFOOD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: food intake
food-related behaviour
obesity
socioeconomic environment
depression
nutritional strategies
Lead sponsor: University of the Balearic Islands
Sponsor class: OTHER
Collaborators: name: VU University of Amsterdam
name: University of Exeter
name: University of Leipzig
First posted: 2015-08-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age 18- 75 years
* Body Mass Index 25-40
* PHQ-9 score ≥ 5

Exclusion Criteria:

* Current (in past 6 months) clinical Major Depressive Disorder Episode (according to psychiatric DSM-IV criteria as determined with The Mini-International Neuropsychiatric Interview 5.0 (M.I.N.I. 5.0)
* Current (in past 6 months) use of antidepressant drugs or psychological interventions.
* History of psychosis, bipolar disorder, substance dependence or other severe, psychiatric disorder that requires specialized clinical attention. No eating disorders. This will all be measured with a brief self-report questionnaire.
* History of bariatric surgery and no current severe, life-threatening disease (assessed using self-report), and no severe cognitive impairment limiting the conduct of the study, as assessed through research staff- evaluation of feasibility of conducting the screening instruments in an adequate manner.
* Currently adhering to supervised behavioural interventions that intervene with MoodFood interventions. If persons are on specific dietary supplements that are competing with the MoodFood intervention, than persons must be willing to stop what they were using before the start of this study
* Non pregnant or breast feeding

Primary outcomes:
measure: Cumulative incidence of Major depressive Disorder
timeFrame: 12 months
Secondary outcomes:
measure: Depressive Symptomatology PHQ-9
timeFrame: 3, 6 and 12 months
measure: Depressive symptomatology IDS30-SR
timeFrame: 3, 6 and 12 months
measure: Food and eating behaviour (TEFQ-R18)
timeFrame: 3, 6 and 12 months
measure: Food behaviour questionnaire
timeFrame: 3, 6 and 12 months
measure: Food intake GA2LEN-FFQ
timeFrame: 6 and 12 months
measure: Physical activity and sedentary behavior (composite)
timeFrame: 3, 6 and 12 months
measure: Body weight perception
timeFrame: 3, 6 and 12 months
measure: Anxiety symptoms (GAD-7)
timeFrame: 3, 6 and 12 months
measure: Health-related quality of life
timeFrame: 3, 6 and 12 months
measure: Sedentary behaviour by accelerometry in some participants
timeFrame: 3, 6 and 12 months
Other outcomes:
measure: Body weight (composite)
timeFrame: 3, 6 and 12 months
measure: Body composition (composite)
timeFrame: 3, 6 and 12 months
measure: Behavioral functionality Assessed with Behavioral activation for Depression Scale (BADS)
timeFrame: 3, 6 and 12 months
measure: Physical activity and habits strength
timeFrame: 3, 6 and 12 months
measure: Blood sample ( blood levels of the nutrients provided with the multi-nutrient supplement)
timeFrame: 6 and 12 months
measure: Self-report of Somatic health status
timeFrame: 6 and 12 months
Locations:
city: Leipzig
country: Germany
facility: Universität Leipzig
state: Saxony
city: Amsterdam
country: Netherlands
facility: VU Amsterdan University
state: North Holland
city: Palma de Mallorca
country: Spain
facility: University of Balearic Islands
state: Balearic Islands
city: Exeter
country: United Kingdom
facility: University of Exeter
state: Devon
Study officials:
affiliation: VU University of Amsterdam
name: Marjolein Visser, PhD
role: STUDY_DIRECTOR
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