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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Multi-country cOllaborative Project on the rOle of Diet, FOod-related Behaviour, and Obesity in the Prevention of Depression (MoodFOOD)

Conditions
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Depression

Intervention / Treatment
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* Dietary Supplement: Multi-nutrient supplement
* Behavioral: Behavioral Activation
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Other: Placebo<br>* Placebo pills identical in look and taste but including no active ingredients<br>|
| Experimental: Multi-nutrient supplement<br>Multi-nutrient supplement | Dietary Supplement: Multi-nutrient supplement<br>* Omega 3 fatty acids Folic acid Calcium Selenium Vitamin D3<br>|
| Experimental: Placebo + Behavioral Activation<br>Placebo + Behavioral Activation | Behavioral: Behavioral Activation<br>* 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.<br>Other: Placebo<br>* Placebo pills identical in look and taste but including no active ingredients<br>|
| Experimental: Multi-nutrient + Behavioral Activation<br>Multi-nutrient + Behavioral Activation | Dietary Supplement: Multi-nutrient supplement<br>* Omega 3 fatty acids Folic acid Calcium Selenium Vitamin D3<br>Behavioral: Behavioral Activation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of Major depressive Disorder | The 12-month cumulative incidence of Major Depressive Disorder (MDD), defined according to the standard psychiatric DSM-IV criteria using The Mini-International Neuropsychiatric Interview 5.0 at 12 months | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive Symptomatology PHQ-9 | Depressive Symptomatology assessed with the Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer, & Williams, 2001) | 3, 6 and 12 months | 
| Depressive symptomatology IDS30-SR | Depressive symptomatology according the Inventory of Depressive Symptomatology (IDS30-SR) (Rush, Gullion, Basco, Jarrett, & Trivedi, 1996) | 3, 6 and 12 months | 
| Food and eating behaviour (TEFQ-R18) | The Three-factor Eating Questionnaire (TEFQ-R18) (Karlsson, Persson, Sjöström, & Sullivan, 2000) | 3, 6 and 12 months | 
| Food behaviour questionnaire | Food Behaviour Questionnaire on meal pattern, snacking behaviour, and other food-related behaviours in the past two weeks, such as mindful eating, cooking and shopping skills, etc. | 3, 6 and 12 months | 
| Food intake GA2LEN-FFQ | The GA2LEN-FFQ (Garcia-Larsen et al., 2011): 6 and 12 months later | 6 and 12 months | 
| Physical activity and sedentary behavior (composite) | Short Questionnaire to Assess Health-Enhancing Physical Activity (SQUASH) (Wendel-Vos, Schuit, Saris, & Kromhout, 2003) and The Sedentary Behavior Questionnaire (SBQ, Rosenberg et al., 2010) | 3, 6 and 12 months | 
| Body weight perception | The Stunkard figure rating scale (Stunkard, Sørensen, & Schulsinger, 1983) | 3, 6 and 12 months | 
| Anxiety symptoms (GAD-7) | Generalized Anxiety Disorder Assessment (GAD-7) (Spitzer, Kroenke, Williams, & Löwe, 2006) | 3, 6 and 12 months | 
| Health-related quality of life | EuroQol instrument EQ-5D-5L (EuroQol Group, 1990) | 3, 6 and 12 months | 
| Sedentary behaviour by accelerometry in some participants | Monitoring of sedentary and activity behaviour by accelerometry in some participants | 3, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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food intake, food-related behaviour, obesity, socioeconomic environment, depression, nutritional strategies