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

Primary Purpose

Depression, Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Control Diet (CD)
Healthy Nordic Diet (ND)
Sponsored by
Örebro University, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Depression focused on measuring Depression, Major Depressive Disorder, Diet, Nutrition, Randomized controlled trial, Pilot study, Healthy Nordic diet

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Örebro University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Healthy Nordic Diet (ND)

Control Diet (CD)

Arm Description

A healthy diet meeting and exceeding the Nordic Nutrition Recommendations and with more than 80% foods from the Nordic region.

A control diet approximating the average depressed person's diet, i.e. of somewhat lower quality than the average Swedish diet.

Outcomes

Primary Outcome Measures

Median rating of the liking of all meals as assessed by a Likert item (the Hedonic scale)
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.
Median rating of the appearance of all meals as assessed by an original Likert item
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.
Median rating of the smell of all meals as assessed by an original Likert item
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.
Median rating of the extent to which the smell matches the appearance of the meals as assessed by an original Likert item
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.
Median rating of the taste intensity of all meals as assessed by a Just About Right (JAR) scale
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.
Median rating of the portion size of all meals as assessed by a Just About Right (JAR) scale
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.
Median rating of feelings of fullness after the meals as assessed by an original visual analog scale (VAS)
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.
Median perception of healthiness of all meals as assessed by an original visual analog scale (VAS)
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.
Total amount of non-study foods consumed as assessed by self-report on a questionnaire every evening
Total amount of non-study drinks consumed as assessed by self-report on a questionnaire every evening
Total amount of provided juice drink not consumed as assessed by self-report on a questionnaire every evening.
Applies to the CD group only.
Rating of how easy it was to follow the protocol, as assessed by an original Likert item on the final questionnaire
1=It was very hard, and 7=It was very easy
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)
Assessed by an original Likert item on the final questionnaire where 1=It would be very hard, and 7=It would be very easy

Secondary Outcome Measures

Change in work impairment after 8 days, as calculated from questions of the Work Productivity and Activity Impairment (WPAI) questionnaire
Expressed as percentage impairment, from 0-100%, where higher values indicate greater impairment in work ability
Change in activity impairment after 8 days, as calculated from questions of the Work Productivity and Activity Impairment (WPAI) questionnaire
Expressed as percentage impairment, from 0-100%, where higher values indicate greater impairment in ability to perform daily activities.
Change in gastrointestinal symptom severity after 8 days, as assessed by the total mean score of the Gastrointestinal Symptoms Rating Scale (GSRS) questionnaire
1=no symptoms, 7=very severe symptoms
Change in indigestion symptom severity after 8 days, as assessed by the indigestion sub-score of the Gastrointestinal Symptoms Rating Scale (GSRS) questionnaire
1=no symptoms, 7=very severe symptoms
Change in physical activity level after 8 days, as assessed by the Frändin-Grimby Physical Activity Scale
Score of 1-6, from least to most active
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
Score of 0-54, from least to most severe symptoms
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
0=Worst health imaginable, 100=Best health imaginable
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
0=health as bad as dead, 1=full health
Self-reported change in health after 8 days, as assessed by a written open-ended response on the final questionnaire
Due to the open-ended, self-reported nature of the responses, they are summarized narratively rather than quantitatively.
Change in body weight after 8 days, as assessed by self-measurement or approximation
Change between self-reported baseline and follow-up body weights calculated.

Full Information

First Posted
January 16, 2021
Last Updated
January 28, 2021
Sponsor
Örebro University, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT04731454
Brief Title
Feasibility and Acceptability of a Healthy Nordic Diet Intervention in Depressed and Non-depressed Adults
Official Title
Feasibility and Acceptability of a Healthy Nordic Diet Intervention for the Treatment of Depression: a Randomized Controlled Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
October 2, 2020 (Actual)
Study Completion Date
October 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Örebro University, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Major Depressive Disorder
Keywords
Depression, Major Depressive Disorder, Diet, Nutrition, Randomized controlled trial, Pilot study, Healthy Nordic diet

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Nordic Diet (ND)
Arm Type
Experimental
Arm Description
A healthy diet meeting and exceeding the Nordic Nutrition Recommendations and with more than 80% foods from the Nordic region.
Arm Title
Control Diet (CD)
Arm Type
Experimental
Arm Description
A control diet approximating the average depressed person's diet, i.e. of somewhat lower quality than the average Swedish diet.
Intervention Type
Other
Intervention Name(s)
Control Diet (CD)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Healthy Nordic Diet (ND)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Median rating of the liking of all meals as assessed by a Likert item (the Hedonic scale)
Description
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.
Time Frame
8 days
Title
Median rating of the appearance of all meals as assessed by an original Likert item
Description
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.
Time Frame
8 days
Title
Median rating of the smell of all meals as assessed by an original Likert item
Description
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.
Time Frame
8 days
Title
Median rating of the extent to which the smell matches the appearance of the meals as assessed by an original Likert item
Description
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.
Time Frame
8 days
Title
Median rating of the taste intensity of all meals as assessed by a Just About Right (JAR) scale
Description
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.
Time Frame
8 days
Title
Median rating of the portion size of all meals as assessed by a Just About Right (JAR) scale
Description
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.
Time Frame
8 days
Title
Median rating of feelings of fullness after the meals as assessed by an original visual analog scale (VAS)
Description
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.
Time Frame
8 days
Title
Median perception of healthiness of all meals as assessed by an original visual analog scale (VAS)
Description
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.
Time Frame
8 days
Title
Total amount of non-study foods consumed as assessed by self-report on a questionnaire every evening
Time Frame
8 days
Title
Total amount of non-study drinks consumed as assessed by self-report on a questionnaire every evening
Time Frame
8 days
Title
Total amount of provided juice drink not consumed as assessed by self-report on a questionnaire every evening.
Description
Applies to the CD group only.
Time Frame
8 days
Title
Rating of how easy it was to follow the protocol, as assessed by an original Likert item on the final questionnaire
Description
1=It was very hard, and 7=It was very easy
Time Frame
8 days
Title
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)
Description
Assessed by an original Likert item on the final questionnaire where 1=It would be very hard, and 7=It would be very easy
Time Frame
8 days
Secondary Outcome Measure Information:
Title
Change in work impairment after 8 days, as calculated from questions of the Work Productivity and Activity Impairment (WPAI) questionnaire
Description
Expressed as percentage impairment, from 0-100%, where higher values indicate greater impairment in work ability
Time Frame
8 days
Title
Change in activity impairment after 8 days, as calculated from questions of the Work Productivity and Activity Impairment (WPAI) questionnaire
Description
Expressed as percentage impairment, from 0-100%, where higher values indicate greater impairment in ability to perform daily activities.
Time Frame
8 days
Title
Change in gastrointestinal symptom severity after 8 days, as assessed by the total mean score of the Gastrointestinal Symptoms Rating Scale (GSRS) questionnaire
Description
1=no symptoms, 7=very severe symptoms
Time Frame
8 days
Title
Change in indigestion symptom severity after 8 days, as assessed by the indigestion sub-score of the Gastrointestinal Symptoms Rating Scale (GSRS) questionnaire
Description
1=no symptoms, 7=very severe symptoms
Time Frame
8 days
Title
Change in physical activity level after 8 days, as assessed by the Frändin-Grimby Physical Activity Scale
Description
Score of 1-6, from least to most active
Time Frame
8 days
Title
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
Description
Score of 0-54, from least to most severe symptoms
Time Frame
8 days
Title
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
Description
0=Worst health imaginable, 100=Best health imaginable
Time Frame
8 days
Title
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
Description
0=health as bad as dead, 1=full health
Time Frame
8 days
Title
Self-reported change in health after 8 days, as assessed by a written open-ended response on the final questionnaire
Description
Due to the open-ended, self-reported nature of the responses, they are summarized narratively rather than quantitatively.
Time Frame
8 days
Title
Change in body weight after 8 days, as assessed by self-measurement or approximation
Description
Change between self-reported baseline and follow-up body weights calculated.
Time Frame
8 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia A Sabet, PhD
Organizational Affiliation
Örebro University, Sweden
Official's Role
Study Director
Facility Information:
Facility Name
Örebro University
City
Örebro
State/Province
Närke
ZIP/Postal Code
70182
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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

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