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

NCT02529423 | Completed

• 1 other identifier: FP7KKBE20132101
• Study Type: interventional
• Target: 1,000
• Locations: 4 countries
• Sites: 4

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. 1.Control group (daily placebo supplements)
2. 2.Multi-nutrient supplementation group (daily multi-nutrient supplement)
3. 3.Food-related behavioural change group (food-related behavioural activation focusing on improving overall diet + placebo supplements)
4. 4.Multi-nutrient supplementation + food-related behavioural activation group (daily multi-nutrient supplement + food-related behavioural activation focusing on improving overall diet).

Conditions

Depression

Keywords

food intake; food-related behaviour; obesity; socioeconomic environment; depression; nutritional strategies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Depressive Symptomatology PHQ-9

  3, 6 and 12 months

• Depressive symptomatology IDS30-SR

  3, 6 and 12 months

• Food and eating behaviour (TEFQ-R18)

  3, 6 and 12 months

• Food behaviour questionnaire

  3, 6 and 12 months

• Food intake GA2LEN-FFQ

  6 and 12 months

Other Outcomes (6)

• Body weight (composite)

  3, 6 and 12 months

• Body composition (composite)

  3, 6 and 12 months

• Behavioral functionality Assessed with Behavioral activation for Depression Scale (BADS)

  3, 6 and 12 months

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Multi-nutrient supplement

EXPERIMENTAL

Multi-nutrient supplement

Dietary Supplement: Multi-nutrient supplement

Placebo + Behavioral Activation

EXPERIMENTAL

Placebo + Behavioral Activation

Behavioral: Behavioral Activation; Other: Placebo

Multi-nutrient + Behavioral Activation

EXPERIMENTAL

Multi-nutrient + Behavioral Activation

Dietary Supplement: Multi-nutrient supplement; Behavioral: Behavioral Activation

Interventions

Multi-nutrient supplement DIETARY_SUPPLEMENT

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

Multi-nutrient + Behavioral Activation; Multi-nutrient supplement

Behavioral Activation BEHAVIORAL

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.

Multi-nutrient + Behavioral Activation; Placebo + Behavioral Activation

Placebo OTHER

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

Placebo; Placebo + Behavioral Activation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of the Balearic Islands: lead
• VU University of Amsterdam: collaborator
• University of Exeter: collaborator
• University of Leipzig: collaborator

Study Sites (4)

Universität Leipzig

Leipzig, Saxony, 04109, Germany

Location

VU Amsterdan University

Amsterdam, North Holland, 1081, Netherlands

Location

University of Balearic Islands

Palma de Mallorca, Balearic Islands, 07122, Spain

Location

University of Exeter

Exeter, Devon, EX4 4SB, United Kingdom

Location

Related Publications (16)

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• Owens M, Watkins E, Bot M, Brouwer IA, Roca M, Kohls E, Penninx B, van Grootheest G, Cabout M, Hegerl U, Gili M, Visser M; MooDFOOD Prevention Trial Investigators. Acceptability and feasibility of two interventions in the MooDFOOD Trial: a food-related depression prevention randomised controlled trial in overweight adults with subsyndromal symptoms of depression. BMJ Open. 2020 Sep 15;10(9):e034025. doi: 10.1136/bmjopen-2019-034025.

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• Baldofski S, Mauche N, Dogan-Sander E, Bot M, Brouwer IA, Paans NPG, Cabout M, Gili M, van Grootheest G, Hegerl U, Owens M, Roca M, Visser M, Watkins E, Penninx BWJH, Kohls E. Depressive Symptom Clusters in Relation to Body Weight Status: Results From Two Large European Multicenter Studies. Front Psychiatry. 2019 Nov 21;10:858. doi: 10.3389/fpsyt.2019.00858. eCollection 2019.

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• Grasso AC, Olthof MR, van Dooren C, Roca M, Gili M, Visser M, Cabout M, Bot M, Penninx BWJH, van Grootheest G, Kohls E, Hegerl U, Owens M, Watkins E, Brouwer IA; MooDFOOD Prevention Trial Investigators. Effect of food-related behavioral activation therapy on food intake and the environmental impact of the diet: results from the MooDFOOD prevention trial. Eur J Nutr. 2020 Sep;59(6):2579-2591. doi: 10.1007/s00394-019-02106-1. Epub 2019 Oct 23.

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• Bot M, Brouwer IA, Roca M, Kohls E, Penninx BWJH, Watkins E, van Grootheest G, Cabout M, Hegerl U, Gili M, Owens M, Visser M; MooDFOOD Prevention Trial Investigators. Effect of Multinutrient Supplementation and Food-Related Behavioral Activation Therapy on Prevention of Major Depressive Disorder Among Overweight or Obese Adults With Subsyndromal Depressive Symptoms: The MooDFOOD Randomized Clinical Trial. JAMA. 2019 Mar 5;321(9):858-868. doi: 10.1001/jama.2019.0556.

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• Roca M, Kohls E, Gili M, Watkins E, Owens M, Hegerl U, van Grootheest G, Bot M, Cabout M, Brouwer IA, Visser M, Penninx BW; MooDFOOD Prevention Trial Investigators. Prevention of depression through nutritional strategies in high-risk persons: rationale and design of the MooDFOOD prevention trial. BMC Psychiatry. 2016 Jun 8;16:192. doi: 10.1186/s12888-016-0900-z.

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MeSH Terms

Conditions

Depression; Obesity

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marjolein Visser, PhD

  VU University of Amsterdam

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2015
• First Posted: August 20, 2015
• Study Start: July 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2017
• Last Updated: November 30, 2018

Record last verified: 2018-11

Locations

ES (1); DE (1); GB (1); NL (1)