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

• ClinicalTrials.gov Identifier: NCT02529423
• Recruitment Status: Completed
• First Posted: August 20, 2015
• Last Update Posted: November 30, 2018
• Sponsor: University of the Balearic Islands
• Collaborators: VU University of Amsterdam; University of Exeter; University of Leipzig
• Information provided by (Responsible Party): University of the Balearic Islands

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Depression	Dietary Supplement: Multi-nutrient supplement; Behavioral: Behavioral Activation; Other: Placebo	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1000 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Multi-country cOllaborative Project on the rOle of Diet, FOod-related Behaviour, and Obesity in the Prevention of Depression (MoodFOOD)
• Actual Study Start Date: July 2015
• Actual Primary Completion Date: October 2016
• Actual Study Completion Date: October 2017

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Placebo	Other: Placebo; Placebo pills identical in look and taste but including no active ingredients
Experimental: Multi-nutrient supplement; Multi-nutrient supplement	Dietary Supplement: Multi-nutrient supplement; Omega 3 fatty acids; Folic acid; Calcium; Selenium; Vitamin D3
Experimental: Placebo + Behavioral Activation; Placebo + Behavioral Activation	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
Experimental: Multi-nutrient + Behavioral Activation; Multi-nutrient + Behavioral Activation	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.

Outcome Measures

Primary Outcome Measures :

1. Cumulative incidence of Major depressive Disorder [ Time Frame: 12 months ]
   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

Secondary Outcome Measures :

1. Depressive Symptomatology PHQ-9 [ Time Frame: 3, 6 and 12 months ]
   Depressive Symptomatology assessed with the Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer, & Williams, 2001)
2. Depressive symptomatology IDS30-SR [ Time Frame: 3, 6 and 12 months ]
   Depressive symptomatology according the Inventory of Depressive Symptomatology (IDS30-SR) (Rush, Gullion, Basco, Jarrett, & Trivedi, 1996)
3. Food and eating behaviour (TEFQ-R18) [ Time Frame: 3, 6 and 12 months ]
   The Three-factor Eating Questionnaire (TEFQ-R18) (Karlsson, Persson, Sjöström, & Sullivan, 2000)
4. Food behaviour questionnaire [ Time Frame: 3, 6 and 12 months ]
   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.
5. Food intake GA2LEN-FFQ [ Time Frame: 6 and 12 months ]
   The GA2LEN-FFQ (Garcia-Larsen et al., 2011): 6 and 12 months later
6. Physical activity and sedentary behavior (composite) [ Time Frame: 3, 6 and 12 months ]
   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)
7. Body weight perception [ Time Frame: 3, 6 and 12 months ]
   The Stunkard figure rating scale (Stunkard, Sørensen, & Schulsinger, 1983)
8. Anxiety symptoms (GAD-7) [ Time Frame: 3, 6 and 12 months ]
   Generalized Anxiety Disorder Assessment (GAD-7) (Spitzer, Kroenke, Williams, & Löwe, 2006)
9. Health-related quality of life [ Time Frame: 3, 6 and 12 months ]
   EuroQol instrument EQ-5D-5L (EuroQol Group, 1990)
10. Sedentary behaviour by accelerometry in some participants [ Time Frame: 3, 6 and 12 months ]
    Monitoring of sedentary and activity behaviour by accelerometry in some participants

Other Outcome Measures:

1. Body weight (composite) [ Time Frame: 3, 6 and 12 months ]
   Measured height, body weight, waist and hip circumference according to standardized measurement protocols, and calculated body mass index
2. Body composition (composite) [ Time Frame: 3, 6 and 12 months ]
   Fat mass, fat-free mass and percentage body fat will be accurately assessed using whole body air-displacement plethysmography in participants from one site.
3. Behavioral functionality Assessed with Behavioral activation for Depression Scale (BADS) [ Time Frame: 3, 6 and 12 months ]
   Activation rumination, avoidance, work/school and social impairment. Assessed with Behavioral activation for Depression Scale (BADS) (Kanter, JW et al., 2012)
4. Physical activity and habits strength [ Time Frame: 3, 6 and 12 months ]
   Self-Report Behavioural Automaticity Index (SRBAI) (Gardner, Abraham, Lally, & de Bruijn, 2012)
5. Blood sample ( blood levels of the nutrients provided with the multi-nutrient supplement) [ Time Frame: 6 and 12 months ]
   In a random subsample of trial participants (n=50 per intervention arm) blood samples will be collected at baseline, and after 6 and 12 months to measure blood levels of the nutrients provided with the multi-nutrient supplement
6. Self-report of Somatic health status [ Time Frame: 6 and 12 months ]
   Self-report of somatic/chronic diseases and family's medical history, smoking, alcohol consumption and medication/supplements use at 6 and 12 months

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Germany

Universität Leipzig

Leipzig, Saxony, Germany, 04109

Netherlands

VU Amsterdan University

Amsterdam, North Holland, Netherlands, 1081

Spain

University of Balearic Islands

Palma de Mallorca, Balearic Islands, Spain, 07122

United Kingdom

University of Exeter

Exeter, Devon, United Kingdom, EX4 4SB

Sponsors and Collaborators

University of the Balearic Islands

VU University of Amsterdam

University of Exeter

University of Leipzig

Investigators

• Study Director: Marjolein Visser, PhD; VU University of Amsterdam

More Information

Additional Information:

MooDFOOD Trial Data Analysis Plan (added on June 15th 2017) 

Publications:

EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.

Garcia-Larsen V, Luczynska M, Kowalski ML, Voutilainen H, Ahlstrom M, Haahtela T, Toskala E, Bockelbrink A, Lee HH, Vassilopoulou E, Papadopoulos NG, Ramalho R, Moreira A, Delgado L, Castel-Branco MG, Calder PC, Childs CE, Bakolis I, Hooper R, Burney PG; GA2LEN-WP 1.2 'Epidemiological and Clinical Studies'. Use of a common food frequency questionnaire (FFQ) to assess dietary patterns and their relation to allergy and asthma in Europe: pilot study of the GA2LEN FFQ. Eur J Clin Nutr. 2011 Jun;65(6):750-6. doi: 10.1038/ejcn.2011.15. Epub 2011 Mar 23.

Gardner B, Abraham C, Lally P, de Bruijn GJ. Towards parsimony in habit measurement: testing the convergent and predictive validity of an automaticity subscale of the Self-Report Habit Index. Int J Behav Nutr Phys Act. 2012 Aug 30;9:102. doi: 10.1186/1479-5868-9-102.

Kanter JW, Mulick PS, Busch AM, Berlin KS, Martell CR. (2012) . Behavioral Activation for Depression Scale (BADS) (Long and Short Form). Measurement Instrument Database for the Social Science. Retrieved from www.midss.ie

Karlsson J, Persson LO, Sjostrom L, Sullivan M. Psychometric properties and factor structure of the Three-Factor Eating Questionnaire (TFEQ) in obese men and women. Results from the Swedish Obese Subjects (SOS) study. Int J Obes Relat Metab Disord. 2000 Dec;24(12):1715-25. doi: 10.1038/sj.ijo.0801442.

Rosenberg DE, Norman GJ, Wagner N, Patrick K, Calfas KJ, Sallis JF. Reliability and validity of the Sedentary Behavior Questionnaire (SBQ) for adults. J Phys Act Health. 2010 Nov;7(6):697-705. doi: 10.1123/jpah.7.6.697.

Rush AJ, Gullion CM, Basco MR, Jarrett RB, Trivedi MH. The Inventory of Depressive Symptomatology (IDS): psychometric properties. Psychol Med. 1996 May;26(3):477-86. doi: 10.1017/s0033291700035558.

Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

Stunkard AJ, Sorensen T, Schulsinger F. Use of the Danish Adoption Register for the study of obesity and thinness. Res Publ Assoc Res Nerv Ment Dis. 1983;60:115-20. No abstract available.

Wendel-Vos GC, Schuit AJ, Saris WH, Kromhout D. Reproducibility and relative validity of the short questionnaire to assess health-enhancing physical activity. J Clin Epidemiol. 2003 Dec;56(12):1163-9. doi: 10.1016/s0895-4356(03)00220-8.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Paans NPG, Bot M, Brouwer IA, Visser M, Gili M, Roca M, Hegerl U, Kohls E, Owens M, Watkins E, Penninx BWJH; MooDFOOD Prevention Trial Investigators. Effects of food-related behavioral activation therapy on eating styles, diet quality and body weight change: Results from the MooDFOOD Randomized Clinical Trial. J Psychosom Res. 2020 Jul 30;137:110206. doi: 10.1016/j.jpsychores.2020.110206. Online ahead of print.

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.

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.

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.

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.

• Responsible Party: University of the Balearic Islands
• ClinicalTrials.gov Identifier: NCT02529423
• Other Study ID Numbers: FP7KKBE20132101
• First Posted: August 20, 2015
• Last Update Posted: November 30, 2018
• Last Verified: November 2018

Keywords provided by University of the Balearic Islands:

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

Additional relevant MeSH terms:

Obesity; Depression; Depressive Disorder; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Behavioral Symptoms; Mood Disorders; Mental Disorders