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

NCT04731454 | Completed

• 1 other identifier: 2020-03735
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Major Depressive Disorder

Keywords

Depression; Major Depressive Disorder; Diet; Nutrition; Randomized controlled trial; Pilot study; Healthy Nordic diet

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (10)

• Change in work impairment after 8 days, as calculated from questions of the Work Productivity and Activity Impairment (WPAI) questionnaire

  8 days

• Change in activity impairment after 8 days, as calculated from questions of the Work Productivity and Activity Impairment (WPAI) questionnaire

  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

  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

  8 days

• Change in physical activity level after 8 days, as assessed by the Frändin-Grimby Physical Activity Scale

  8 days

Study Arms (2)

Healthy Nordic Diet (ND)

EXPERIMENTAL

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)

Control Diet (CD)

EXPERIMENTAL

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)

Interventions

Control Diet (CD) OTHER

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.

Control Diet (CD)

Healthy Nordic Diet (ND) OTHER

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.

Healthy Nordic Diet (ND)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Örebro University, Sweden: lead

Study Sites (1)

Örebro University

Örebro, Närke, 70182, Sweden

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Julia A Sabet, PhD

  Örebro University, Sweden

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2021
• First Posted: February 1, 2021
• Study Start: September 15, 2020
• Primary Completion: October 2, 2020
• Study Completion: October 2, 2020
• Last Updated: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)