The main objectives of the trial are* To develop innovative evidence*based, feasible, effective and sustainable nutritional strategies for the prevention of depression in EU citizens.* To establish the feasibility and effectiveness of nutritional…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* The 12 month cumulative incidence of Major Depressive Disorder (MDD), defined
according to the standard psychiatric DSM-IV criteria using MINI (Mini
International Neuropsychiatric Interview): baseline, 6 and 12 months later1.
* Depressive symptomatology according the Inventory of Depressive
Symptomatology2;3 baseline, 3, 6, 12 months later.
Secondary outcome
* Depressive Symptomatology assessed with the Patient Health Questionnaire
(PHQ-9, Kroenke et al, 2001)
* Food intake (FFQ-GA2LEN)
* Food behaviour and sustainability:
* Food and eating behaviour: The Three-factor Eating Questionnaire (TFEQ-21;
Cappelleri et al, 2009)
* Physical activity and sedentary behaviour with validated questionnaires
(Short Questionnaire to Assess Health - Enhancing Physical Activity (SQUASH,
Wendel-Vos 2003) and sedentary behaviour (SBQ67)
* Body weight perception: The Stunkard figure rating scale (Stunkard et
al.,1983)
* Generalized Anxiety Disorder Assessment (GAD-7; Spitzer et al, 2006) for
anxiety symptoms
* Quality of life (EuroQol instrument, EQ-5D-5L, EuroQol group, 1990)
* Automaticity of good and bad health behaviours and compliance to
Mediterranean diet (Self-reported behavioural automaticity index (SRBAI)
* Behavioural functionality: activation, avoidance/rumination, work /school
impairment and social impairment (The behavioural activation for depression
scale (BADS)
Background summary
Depression is one of the most prevalent, severe and disabling disorders in the
EU and places a heavy burden on individuals and families. Additionally, a large
proportion of the EU population is overweight, which according to previous
research, increases the risk of depression. Recent research has suggested that
there is a bi-directional link between healthy nutrition and psychological
health. It is yet unclear whether nutritional behavior influences the
development of depression in a direct manner or whether other mechanisms like
social environment or obesity are also involved as well. The MooDFOOD
consortium would like to gain a better understanding of the psychological,
lifestyle and environmental pathways underlying the multi-faceted,
bidirectional links of food intake, nutrient status, food-related behaviour and
obesity with depression. The aim of the intervention study is to investigate
whether two different nutritional strategies (a multi*nutrient supplement and
food*related behavioural change) are feasible and effective in preventing
depression in high*risk overweight EU citizens. This will be studied in four
countries across Europe (the Netherlands, United Kingdom, Germany and Spain).
It is hoped that improving food-related behavior and nutrient status may offer
opportunities to prevent depression, especially in people prone to being
overweight.
Study objective
The main objectives of the trial are
* To develop innovative evidence*based, feasible, effective and sustainable
nutritional strategies for the prevention of depression in EU citizens.
* To establish the feasibility and effectiveness of nutritional strategies on
the prevention of depression.
* To develop optimal, sustainable, and evidence*based nutritional strategies
for the prevention of depression.
* To provide and promote guidelines and practical tools for stakeholders which
will improve implementation and thus contribute to nutrition*related prevention
of depression.
Study design
One-year long two*by*two factorial randomized placebo controlled prevention
trial with two intervention conditions (a multi*nutrient supplement and a food*
related behavioural change (FBC) intervention).
Intervention
* Multi-nutrient supplement: comprising 2 pills a) Omega 3 fatty acids: 1000 mg
per capsule with a EPA/DHA ratio 3:1 (EPA > 700 mg per capsule, DHA > 100 mg
per capsule) b) Multivitamin/minerals pill containing 100 mg calcium, 30 *g
selenium, 400 *g B11-vitamin, 20 *g D-Vitamin.
* Placebo: Sunflower oil capsule with similar filling material and colour as
the fatty acid capsule.
* Food related behavioral change (FBC): The intervention will consist of 21
sessions (15 individuals -30 minutes/each-; 6 group-based sessions -1h-) with a
trained therapist who will target the determines and idiosyncratic triggers of
unhelpful (e.g., mood related snacking) and helpful food related behavior.
Study burden and risks
* Participants will be assessed at baseline, 3, 6, 9 and 12 months (4 site
visits and one optional site visit at 9 months). This will involve an hour long
interview and anthropometric measurements.
* During the baseline assessment patients will be asked to fill in 12
questionnaires
* There is an optional blood draw which will be done at baseline, 6 and 12
months. It will involve 3 x 6ml and 2 x 8.5ml samples.
* Those allocated to the FBC will also need to attend 21, hour long behavioural
therapy sessions spread over a period of 12 months with a therapist.
* All participants will be required to take a pill, either a placebo, or a
multi-nutrient supplement every day for a year.
The contents of the multi-nutrient supplement will be similar to that
available in over-the-counter supplements, hence well under maximum recommended
daily dose, thereby presenting no health risks to the participants.
AJ Ernststraat 1187
Amsterdam 1081HL
NL
AJ Ernststraat 1187
Amsterdam 1081HL
NL
Listed location countries
Age
Inclusion criteria
Age 18*75 years, 2) BMI *25 - 40 kg/m2, 3) High depressive symptom score (PHQ-9 score > 5)
Exclusion criteria
1) Current clinical depression diagnosis (according to psychiatric DSM*IV criteria as
determined with the MINI international neuropsychiatric interview);
2) Current use of antidepressant drugs or psychological interventions,
3) History of psychosis, bipolar disorder, substance, dependence or other severe, psychiatric disorder that requires specialized clinical attention,
4) History of bariatric surgery or current severe, life*threatening disease.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | Dit wordt gedaan na goedkeuring onderzoek door METC |
| CCMO | NL52702.029.15 |