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

NCT ID: NCT02529423

Last Updated: 2018-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2017-10-31

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo pills identical in look and taste but including no active ingredients

Multi-nutrient supplement

Multi-nutrient supplement

Group Type: EXPERIMENTAL

Multi-nutrient supplement

Intervention Type: DIETARY_SUPPLEMENT

• Omega 3 fatty acids
• Folic acid
• Calcium
• Selenium
• Vitamin D3

Placebo + Behavioral Activation

Placebo + Behavioral Activation

Group Type: EXPERIMENTAL

Behavioral Activation

Intervention Type: BEHAVIORAL

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.

Placebo

Intervention Type: OTHER

Placebo pills identical in look and taste but including no active ingredients

Multi-nutrient + Behavioral Activation

Multi-nutrient + Behavioral Activation

Group Type: EXPERIMENTAL

Multi-nutrient supplement

Intervention Type: DIETARY_SUPPLEMENT

• Omega 3 fatty acids
• Folic acid
• Calcium
• Selenium
• Vitamin D3

Behavioral Activation

Intervention Type: BEHAVIORAL

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.

Interventions

Multi-nutrient supplement

• Omega 3 fatty acids
• Folic acid
• Calcium
• Selenium
• Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: BEHAVIORAL

Placebo

Placebo pills identical in look and taste but including no active ingredients

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VU University of Amsterdam

OTHER

Sponsor Role: collaborator

University of Exeter

OTHER

Sponsor Role: collaborator

University of Leipzig

OTHER

Sponsor Role: collaborator

University of the Balearic Islands

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marjolein Visser, PhD

Role: STUDY_DIRECTOR

VU University of Amsterdam

Locations

Universität Leipzig

Leipzig, Saxony, Germany

VU Amsterdan University

Amsterdam, North Holland, Netherlands

University of Balearic Islands

Palma de Mallorca, Balearic Islands, Spain

University of Exeter

Exeter, Devon, United Kingdom

Countries

Germany; Netherlands; Spain; United Kingdom

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Other Identifiers

FP7KKBE20132101

Identifier Type: -

Identifier Source: org_study_id