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

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: Completed
• Conditions: Depression; Major Depressive Disorder
• Intervention / Treatment: Other: Healthy Nordic Diet (ND); Other: Control Diet (CD)

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: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Närke
    • Örebro, Närke, Sweden, 70182
      • Örebro University

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	8 days
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.	8 days
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.	8 days
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.	8 days
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.	8 days
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.	8 days
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.	8 days
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.	8 days
Total amount of non-study foods consumed as assessed by self-report on a questionnaire every evening		8 days
Total amount of non-study drinks consumed as assessed by self-report on a questionnaire every evening		8 days
Total amount of provided juice drink not consumed as assessed by self-report on a questionnaire every evening.	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	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)	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

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	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	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	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	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	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	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	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	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	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	Change between self-reported baseline and follow-up body weights calculated.	8 days

Collaborators and Investigators

• Sponsor: Örebro University, Sweden
• Investigators: Study Director: Julia A Sabet, PhD, Örebro University, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): October 2, 2020
• Study Completion (Actual): October 2, 2020

Study Registration Dates

• First Submitted: January 16, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): February 1, 2021

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Depression; Randomized controlled trial; Nutrition; Diet; Major Depressive Disorder; Pilot study; Healthy Nordic diet
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID 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