Feasibility and Acceptability of a Healthy Nordic Diet Intervention in Depressed and Non-depressed Adults

January 28, 2021 updated by: Örebro University, Sweden

Feasibility and Acceptability of a Healthy Nordic Diet Intervention for the Treatment of Depression: a Randomized Controlled Pilot Trial

In the future, we plan to conduct an 8-week diet intervention to investigate whether a healthy Nordic diet improves depression symptoms. The present pilot study tested whether the planned meals and diets were well-liked and accepted by participants (both depressed and non-depressed) in order to ensure that the future diet intervention will be feasible and successful. We also investigated whether any changes in health occurred after 8 days of this diet intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

After providing their written informed consent, participants were randomized to receive either a healthy Nordic diet or a control diet for 8 days. All meals were provided and minimal food preparation was required. Participants picked up their food outside the study kitchen every 3 days. Before and after the intervention, health-related self-rated questionnaires were completed. For every meal during the intervention, participants completed a questionnaire on their perceptions of the meal. Every evening a questionnaire was completed to assess dietary adherence. At the end of the study, a final evaluation questionnaire was completed to assess participants' perceptions of the diet and study as a whole.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Närke
      • Örebro, Närke, Sweden, 70182
        • Örebro university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • If depressed, a score between 13 and 34 on the Montgomery-Åsberg Depression Rating Scale, self-rated (MADRS-S), indicating mild or moderate depression

Exclusion Criteria:

  • A score of 8 or higher (out of a maximum of 12 points) on a brief diet survey (the retired version of the Swedish Food Agency's online Matvanekollen, conducted via phone interview), indicating a relatively healthy habitual diet
  • Presence of food allergies, intolerances or sensitivities
  • Consuming any form of special diet that excludes certain foods, for example a vegetarian or gluten-free diet
  • Suicidality, indicated by a score of 4 or higher on the MADRS-S suicidality question.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Healthy Nordic Diet (ND)
A healthy diet meeting and exceeding the Nordic Nutrition Recommendations and with more than 80% foods from the Nordic region.
Other: Healthy Nordic Diet (ND)
All food was provided to participants for the duration of the intervention (8 days), including prepared lunches and dinners and ingredients for breakfasts and snacks. Water, milk, coffee, tea and alcohol were consumed as usual.
Experimental: Control Diet (CD)
A control diet approximating the average depressed person's diet, i.e. of somewhat lower quality than the average Swedish diet.
Other: Control Diet (CD)
All food was provided to participants for the duration of the intervention (8 days), including prepared lunches and dinners and ingredients for breakfasts and snacks. A sugar-sweetened juice drink was provided for consumption of one portion per day. Water, milk, coffee, tea and alcohol were consumed as usual.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Median rating of the liking of all meals as assessed by a Likert item (the Hedonic scale)
Time Frame: 8 days
1=Dislike very much, and 7=Like very much. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
8 days
Median rating of the appearance of all meals as assessed by an original Likert item
Time Frame: 8 days
1=Dislike very much, and 7=Like very much. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
8 days
Median rating of the smell of all meals as assessed by an original Likert item
Time Frame: 8 days
1=Dislike very much, and 7=Like very much. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
8 days
Median rating of the extent to which the smell matches the appearance of the meals as assessed by an original Likert item
Time Frame: 8 days
1=Doesn't match at all, and 5=Matches very well. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
8 days
Median rating of the taste intensity of all meals as assessed by a Just About Right (JAR) scale
Time Frame: 8 days
1=Much too low, 3=Just right, and 5=Much too high. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
8 days
Median rating of the portion size of all meals as assessed by a Just About Right (JAR) scale
Time Frame: 8 days
1=Much too small, 4=Just right, and 7=Much too big. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
8 days
Median rating of feelings of fullness after the meals as assessed by an original visual analog scale (VAS)
Time Frame: 8 days
0=Not at all full, and 100=Have never felt so full. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
8 days
Median perception of healthiness of all meals as assessed by an original visual analog scale (VAS)
Time Frame: 8 days
0=Not at all healthy, and 100=Very healthy. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
8 days
Total amount of non-study foods consumed as assessed by self-report on a questionnaire every evening
Time Frame: 8 days
8 days
Total amount of non-study drinks consumed as assessed by self-report on a questionnaire every evening
Time Frame: 8 days
8 days
Total amount of provided juice drink not consumed as assessed by self-report on a questionnaire every evening.
Time Frame: 8 days
Applies to the CD group only.
8 days
Rating of how easy it was to follow the protocol, as assessed by an original Likert item on the final questionnaire
Time Frame: 8 days
1=It was very hard, and 7=It was very easy
8 days
Rating of how easy it would be to participate in such a study, with meals recurring every 8 days for 8 weeks (but not having to fill out a questionnaire for the meals)
Time Frame: 8 days
Assessed by an original Likert item on the final questionnaire where 1=It would be very hard, and 7=It would be very easy
8 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in work impairment after 8 days, as calculated from questions of the Work Productivity and Activity Impairment (WPAI) questionnaire
Time Frame: 8 days
Expressed as percentage impairment, from 0-100%, where higher values indicate greater impairment in work ability
8 days
Change in activity impairment after 8 days, as calculated from questions of the Work Productivity and Activity Impairment (WPAI) questionnaire
Time Frame: 8 days
Expressed as percentage impairment, from 0-100%, where higher values indicate greater impairment in ability to perform daily activities.
8 days
Change in gastrointestinal symptom severity after 8 days, as assessed by the total mean score of the Gastrointestinal Symptoms Rating Scale (GSRS) questionnaire
Time Frame: 8 days
1=no symptoms, 7=very severe symptoms
8 days
Change in indigestion symptom severity after 8 days, as assessed by the indigestion sub-score of the Gastrointestinal Symptoms Rating Scale (GSRS) questionnaire
Time Frame: 8 days
1=no symptoms, 7=very severe symptoms
8 days
Change in physical activity level after 8 days, as assessed by the Frändin-Grimby Physical Activity Scale
Time Frame: 8 days
Score of 1-6, from least to most active
8 days
Change in depression severity after 8 days, as assessed by the total score of the Montgomery-Åsberg Depression Rating Scale, self-rated (MADRS-S) questionnaire
Time Frame: 8 days
Score of 0-54, from least to most severe symptoms
8 days
Change in perceived general health status after 8 days, as assessed by the visual analog scale (VAS) question of the EuroQol Health-Related Quality of Life (EQ-5D-5L) questionnaire
Time Frame: 8 days
0=Worst health imaginable, 100=Best health imaginable
8 days
Change in general health after 8 days, as assessed by the summary index value calculated from the questions of the EuroQol Health-Related Quality of Life (EQ-5D-5L) questionnaire
Time Frame: 8 days
0=health as bad as dead, 1=full health
8 days
Self-reported change in health after 8 days, as assessed by a written open-ended response on the final questionnaire
Time Frame: 8 days
Due to the open-ended, self-reported nature of the responses, they are summarized narratively rather than quantitatively.
8 days
Change in body weight after 8 days, as assessed by self-measurement or approximation
Time Frame: 8 days
Change between self-reported baseline and follow-up body weights calculated.
8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Örebro University, Sweden

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Julia A Sabet, PhD, Örebro University, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 2, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 2, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-03735

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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