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

Depression Clinical Trial

— MoodFOOD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02529423
• Other study ID #: FP7KKBE20132101
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: October 2017

Study information

• Verified date: November 2018
• Source: University of the Balearic Islands
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: October 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Obesity

Intervention

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

Locations

Country	Name	City	State
Germany	Universität Leipzig	Leipzig	Saxony
Netherlands	VU Amsterdan University	Amsterdam	North Holland
Spain	University of Balearic Islands	Palma de Mallorca	Balearic Islands
United Kingdom	University of Exeter	Exeter	Devon

Sponsors (4)

Lead Sponsor	Collaborator
University of the Balearic Islands	University of Exeter, University of Leipzig, VU University of Amsterdam

Countries where clinical trial is conducted

Germany,  Netherlands,  Spain,  United Kingdom, 

References & Publications (10)

EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. — View Citation

Garcia-Larsen V, Luczynska M, Kowalski ML, Voutilainen H, Ahlström 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. — View Citation

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. — View Citation

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, Sjöström 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. — View Citation

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. — View Citation

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. — View Citation

Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. — View Citation

Stunkard AJ, Sørensen 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body weight (composite)	Measured height, body weight, waist and hip circumference according to standardized measurement protocols, and calculated body mass index	3, 6 and 12 months
Other	Body composition (composite)	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, 6 and 12 months
Other	Behavioral functionality Assessed with Behavioral activation for Depression Scale (BADS)	Activation rumination, avoidance, work/school and social impairment. Assessed with Behavioral activation for Depression Scale (BADS) (Kanter, JW et al., 2012)	3, 6 and 12 months
Other	Physical activity and habits strength	Self-Report Behavioural Automaticity Index (SRBAI) (Gardner, Abraham, Lally, & de Bruijn, 2012)	3, 6 and 12 months
Other	Blood sample ( blood levels of the nutrients provided with the multi-nutrient supplement)	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 and 12 months
Other	Self-report of Somatic health status	Self-report of somatic/chronic diseases and family's medical history, smoking, alcohol consumption and medication/supplements use at 6 and 12 months	6 and 12 months
Primary	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	Depressive Symptomatology PHQ-9	Depressive Symptomatology assessed with the Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer, & Williams, 2001)	3, 6 and 12 months
Secondary	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
Secondary	Food and eating behaviour (TEFQ-R18)	The Three-factor Eating Questionnaire (TEFQ-R18) (Karlsson, Persson, Sjöström, & Sullivan, 2000)	3, 6 and 12 months
Secondary	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
Secondary	Food intake GA2LEN-FFQ	The GA2LEN-FFQ (Garcia-Larsen et al., 2011): 6 and 12 months later	6 and 12 months
Secondary	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
Secondary	Body weight perception	The Stunkard figure rating scale (Stunkard, Sørensen, & Schulsinger, 1983)	3, 6 and 12 months
Secondary	Anxiety symptoms (GAD-7)	Generalized Anxiety Disorder Assessment (GAD-7) (Spitzer, Kroenke, Williams, & Löwe, 2006)	3, 6 and 12 months
Secondary	Health-related quality of life	EuroQol instrument EQ-5D-5L (EuroQol Group, 1990)	3, 6 and 12 months
Secondary	Sedentary behaviour by accelerometry in some participants	Monitoring of sedentary and activity behaviour by accelerometry in some participants	3, 6 and 12 months

External Links

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