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

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

Tracking Information
First Submitted Date  ICMJE August 2, 2015
First Posted Date  ICMJE August 20, 2015
Last Update Posted Date November 30, 2018
Actual Study Start Date  ICMJE July 2015
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02529423 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2015)
  • 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)
  • 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)
  • 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)
  • 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.
  • Food intake GA2LEN-FFQ [ Time Frame: 6 and 12 months ]
    The GA2LEN-FFQ (Garcia-Larsen et al., 2011): 6 and 12 months later
  • 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)
  • Body weight perception [ Time Frame: 3, 6 and 12 months ]
    The Stunkard figure rating scale (Stunkard, Sørensen, & Schulsinger, 1983)
  • Anxiety symptoms (GAD-7) [ Time Frame: 3, 6 and 12 months ]
    Generalized Anxiety Disorder Assessment (GAD-7) (Spitzer, Kroenke, Williams, & Löwe, 2006)
  • Health-related quality of life [ Time Frame: 3, 6 and 12 months ]
    EuroQol instrument EQ-5D-5L (EuroQol Group, 1990)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2015)
  • 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)
  • 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)
  • 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)
  • 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.
  • Food intake GA2LEN-FFQ [ Time Frame: 6 and 12 months ]
    The GA2LEN-FFQ (Garcia-Larsen et al., 2011): only at baseline, 6 and 12 months later
  • 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)
  • Body weight perception [ Time Frame: 3, 6 and 12 months ]
    The Stunkard figure rating scale (Stunkard, Sørensen, & Schulsinger, 1983)
  • Anxiety symptoms (GAD-7) [ Time Frame: 3, 6 and 12 months ]
    Generalized Anxiety Disorder Assessment (GAD-7) (Spitzer, Kroenke, Williams, & Löwe, 2006)
  • Health-related quality of life [ Time Frame: 3, 6 and 12 months ]
    EuroQol instrument EQ-5D-5L (EuroQol Group, 1990)
  • 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
Current Other Pre-specified Outcome Measures
 (submitted: August 19, 2015)
  • 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
  • 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.
  • 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)
  • Physical activity and habits strength [ Time Frame: 3, 6 and 12 months ]
    Self-Report Behavioural Automaticity Index (SRBAI) (Gardner, Abraham, Lally, & de Bruijn, 2012)
  • 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
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Multi-country Project on the Role of Diet, Food-related Behavior, and Obesity in the Prevention of Depression
Official Title  ICMJE Multi-country cOllaborative Project on the rOle of Diet, FOod-related Behaviour, and Obesity in the Prevention of Depression (MoodFOOD)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Depression
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: Placebo
  • Experimental: Multi‐nutrient supplement
    Multi‐nutrient supplement
    Intervention: Dietary Supplement: Multi‐nutrient supplement
  • Experimental: Placebo + Behavioral Activation
    Placebo + Behavioral Activation
    Interventions:
    • Behavioral: Behavioral Activation
    • Other: Placebo
  • Experimental: Multi‐nutrient + Behavioral Activation
    Multi‐nutrient + Behavioral Activation
    Interventions:
    • Dietary Supplement: Multi‐nutrient supplement
    • Behavioral: Behavioral Activation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 19, 2015)
1000
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Netherlands,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02529423
Other Study ID Numbers  ICMJE FP7KKBE20132101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of the Balearic Islands
Study Sponsor  ICMJE University of the Balearic Islands
Collaborators  ICMJE
  • VU University of Amsterdam
  • University of Exeter
  • University of Leipzig
Investigators  ICMJE
Study Director: Marjolein Visser, PhD VU University of Amsterdam
PRS Account University of the Balearic Islands
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP