DepressionMoodFOODNCT02529423
Multi-country Project on the Role of Diet, Food-related Behavior, and Obesity in the Prevention of Depression
A study testing Multi-nutrient supplement and Behavioral Activation in people with Depression, run by University of the Balearic Islands at 4 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Multi-nutrient supplement and Behavioral Activation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Jul 2015to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18- 75 years
- Body Mass Index 25-40
- PHQ-9 score ≥ 5
Who cannot join
- 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
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Spain1 site
University of Balearic Islands
Palma de Mallorca, Balearic Islands, 07122
About this study
Official title: Multi-country cOllaborative Project on the rOle of Diet, FOod-related Behaviour, and Obesity in the Prevention of Depression (MoodFOOD)
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Multi-nutrient supplement, Behavioral Activation, Placebo
- Keywords
- food intake, food-related behaviour, obesity, socioeconomic environment, depression, nutritional strategies
- Medical subject headings
- Depression, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-nutrient supplementDietary supplement
- Omega 3 fatty acids
- Folic acid
- Calcium
- Selenium
- Vitamin D3
Behavioral ActivationBehavioural
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.
PlaceboOther
Placebo pills identical in look and taste but including no active ingredients
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
| Multi-nutrient supplement | Experimental | Multi-nutrient supplement Receives: Dietary Supplement: Multi-nutrient supplement |
| Placebo + Behavioral Activation | Experimental | Placebo + Behavioral Activation Receives: Behavioral: Behavioral Activation; Other: Placebo |
| Multi-nutrient + Behavioral Activation | Experimental | Multi-nutrient + Behavioral Activation Receives: Dietary Supplement: Multi-nutrient supplement; Behavioral: Behavioral Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (10)
Depressive Symptomatology PHQ-9
Depressive Symptomatology assessed with the Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer, \& Williams, 2001)
Measured: 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)
Measured: 3, 6 and 12 months
Food and eating behaviour (TEFQ-R18)
The Three-factor Eating Questionnaire (TEFQ-R18) (Karlsson, Persson, Sjöström, \& Sullivan, 2000)
Measured: 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.
Measured: 3, 6 and 12 months
Food intake GA2LEN-FFQ
The GA2LEN-FFQ (Garcia-Larsen et al., 2011): 6 and 12 months later
Measured: 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)
Measured: 3, 6 and 12 months
Body weight perception
The Stunkard figure rating scale (Stunkard, Sørensen, \& Schulsinger, 1983)
Measured: 3, 6 and 12 months
Anxiety symptoms (GAD-7)
Generalized Anxiety Disorder Assessment (GAD-7) (Spitzer, Kroenke, Williams, \& Löwe, 2006)
Measured: 3, 6 and 12 months
Health-related quality of life
EuroQol instrument EQ-5D-5L (EuroQol Group, 1990)
Measured: 3, 6 and 12 months
Sedentary behaviour by accelerometry in some participants
Monitoring of sedentary and activity behaviour by accelerometry in some participants
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2016
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Balearic Islands
- Sponsor type
- University, hospital or other
- Collaborators
- VU University of Amsterdam, University of Exeter, University of Leipzig
- Responsible party
- Sponsor
- Investigators
- Marjolein Visser, PhD, Study director, VU University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529423
- Sponsor's protocol ID
- FP7KKBE20132101
- Acronym
- MoodFOOD
- Status last verified
- Nov 2018
- First submitted
- 2 Aug 2015
- Last updated
- 30 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 10109801Garcia-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.
PubMed 21427744Gardner 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.
PubMed 22935297Kanter 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.
PubMed 11126230Rosenberg 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.
PubMed 21088299Rush 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.
PubMed 8733206Spitzer 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.
PubMed 16717171Stunkard 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.
PubMed 6823524Wendel-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.
PubMed 14680666Owens 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.
PubMed 32933954Paans 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 Oct;137:110206. doi: 10.1016/j.jpsychores.2020.110206. Epub 2020 Jul 30.
PubMed 32798835Baldofski 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.
PubMed 31824355Grasso 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.
PubMed 31642985Bot 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.
PubMed 30835307
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-country cOllaborative Project on the rOle of Diet, FOod-related Behaviour, and Obesity in the Prevention of Depression (MoodFOOD)
- ClinicalTrials.gov ID
- NCT02529423
- Acronym / sponsor ID
- MoodFOOD / FP7KKBE20132101
- Conditions
- Depression
- Keywords
- food intake, food-related behaviour, obesity, socioeconomic environment, depression, nutritional strategies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of the Balearic IslandsUniversity, hospital or other
- Collaborators
- VU University of Amsterdam, University of Exeter, University of Leipzig
- Study start
- Jul 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 20 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
| Multi-nutrient supplement | Experimental | Dietary Supplement: Multi-nutrient supplementMulti-nutrient supplement |
| Placebo + Behavioral Activation | Experimental | Behavioral: Behavioral Activation, Other: PlaceboPlacebo + Behavioral Activation |
| Multi-nutrient + Behavioral Activation | Experimental | Dietary Supplement: Multi-nutrient supplement, Behavioral: Behavioral ActivationMulti-nutrient + Behavioral Activation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18- 75 years
- Body Mass Index 25-40
- PHQ-9 score ≥ 5
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-nutrient supplement* Omega 3 fatty acids * Folic acid * Calcium * Selenium * Vitamin D3 | Dietary supplement | Multi-nutrient + Behavioral Activation, Multi-nutrient supplement |
| Behavioral Activation21 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. | Behavioural | Multi-nutrient + Behavioral Activation, Placebo + Behavioral Activation |
| PlaceboPlacebo pills identical in look and taste but including no active ingredients | Other | Placebo, Placebo + Behavioral Activation |
Primary outcome
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
10 secondary outcomes
Depressive Symptomatology PHQ-9
Time frame: 3, 6 and 12 months
Depressive symptomatology IDS30-SR
Time frame: 3, 6 and 12 months
Food and eating behaviour (TEFQ-R18)
Time frame: 3, 6 and 12 months
Food behaviour questionnaire
Time frame: 3, 6 and 12 months
Food intake GA2LEN-FFQ
Time frame: 6 and 12 months
Physical activity and sedentary behavior (composite)
Time frame: 3, 6 and 12 months
Body weight perception
Time frame: 3, 6 and 12 months
Anxiety symptoms (GAD-7)
Time frame: 3, 6 and 12 months
Health-related quality of life
Time frame: 3, 6 and 12 months
Sedentary behaviour by accelerometry in some participants
Time frame: 3, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2018.
- Background: PubMed 10109801EuroQol 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.
- Background: PubMed 21427744Garcia-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.
- Background: PubMed 22935297Gardner 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.
- BackgroundKanter 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
- Background: PubMed 11126230Karlsson 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.
- Background: PubMed 21088299Rosenberg 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.
- Background: PubMed 8733206Rush 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.
- Background: PubMed 16717171Spitzer 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.
- Background: PubMed 6823524Stunkard 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.
- Background: PubMed 14680666Wendel-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.
- Derived from this study: PubMed 32933954Owens 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.
- Derived from this study: PubMed 32798835Paans 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 Oct;137:110206. doi: 10.1016/j.jpsychores.2020.110206. Epub 2020 Jul 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marjolein Visser, PhD study director
VU University of Amsterdam
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-nutrient supplement and Behavioral Activation in people with Depression, run by University of the Balearic Islands at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Netherlands, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of Major depressive Disorder (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02529423, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2018.