Depressive SymptomsNCT06448117
Mind Nutrition Study. Effectiveness of Improving Nutrition on Depressive Symptoms and Work Ability
A study testing Mind Nutrition in people with Depressive Symptoms and Nutrition, Healthy, run by Satakunta University of Applied Sciences at 1 site in Finland.
Trial summary
The goal of this randomized, controlled trial is to examine the effectiveness of dietary counseling on depressive symptoms, work ability, and quality of life in mental health and substance abuse professionals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Nutrition, Healthy, Quality of Life
- What is being tested?
- Mind Nutrition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteFinland
- Study dates
- 1 Sep 2024to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged at least 18 year
- Adequate Finnish language skills
- Work-capable
- Currently employed by Satakunta wellbeing services county for at least 6 months
- Works in the field of mental health and substance abuse
- Education either practical nurse, registered nurse, mental health nurse, or Bachelor of Social Services (in Finnish: Sosionomi)
- Agrees to commit to either of the groups (intervention/control) for 6 months
- Able to give informed consent.
Who cannot join
- Acute mental health symptoms and incapable to work
- Terminal phase disease or unstable severe chronic disease (consultation of the doctor in charge)
- Employed for a shorter period than 6 months
- Has a history of an eating disorder (consultation of the doctor in charge)
- Center for Epidemiological Studies - Depression (CES-D) score ≥16 and reduced work capacity (presenteeism) (consultation of the medical expert in mental health)
- Substance abuse based on the AUDIT-C score (consultation of the doctor in charge)
Trial locations and contacts
1 site in 1 country.
Finland1 site
Satakunta University of Applied Sciences
Pori, Satakunta, 28130
Susanna Kunvik, PhD, +358447103204, susanna.kunvik@samk.fi
Aino Kipfer, MSc, +358505678410, aino.kipfer@samk.fi
About this study
The goal of this randomized, controlled trial is to examine the effectiveness of dietary counseling on depressive symptoms, work ability, and quality of life in mental health and substance abuse professionals. The main questions it aims to answer are:
- Whether dietary counseling can lower depressive symptoms and depressive symptoms-related sick leave days and improve work ability among mental health and substance abuse professionals
- Whether dietary counseling can improve life quality, diet quality, and eating behavior among mental health and substance abuse professionals.
Read more
Subjects of the intervention group will participate in five dietary counseling sessions during six months. Participants in the control group do not receive any intervention.
Researchers will compare the intervention and control groups to see if dietary counseling is effective in reducing the risk of depressiveness and depression-related sick leave days and improving work ability, quality of life, and nutritional habits.
Read the detailed description
Background. Depressive disorders are a growing public health concern. Depression is linked to increases in work absenteeism, short-term disability, decreased productivity, and presenteeism and has become a global public health challenge. The association between nutrition and the risk of depressiveness is recognized, but there are no published randomized, controlled whole-diet intervention studies with the main aim of depression prevention. It is essential to investigate the impact of nutrition counseling on symptoms of depression in high-risk groups.
Aims. This Mind Nutrition randomized, controlled trial is part of the Mind Nutrition study that combines the intervention part and a cross-sectional examination that utilizes a separate dataset. The primary aim of the intervention study is to examine whether improving nutrition can (cost-effectively) reduce depressive symptoms and related sick leave and enhance work ability. Secondary aims are to measure the effects of the intervention on diet quality, life quality, and eating behavior, evaluate the attainment of participants' personal goals, and assess the acceptability of the intervention.
Methods. The randomized, controlled trial examines the effectiveness of six-month nutritional counseling on depressive symptoms and work ability among practical and registered nurses and social welfare professionals (n=125) working in the mental health and substance abuse field of the Satakunta wellbeing services county. Half of the participants are randomized into the intervention group and half into the control group. The six-month intervention includes two individual and three group counseling sessions. The control group will not receive any intervention but, instead, continue their habitual diet. The investigators measure the outcomes utilizing questionnaires and three-day food records at baseline and the end of the intervention. Weight and blood pressure will be measured at the same time points.
Discussion. This study will provide nationally and internationally crucial evidence on the effectiveness of nutrition counseling on depressive symptoms, work ability, and quality of life.
- Conditions
- Depressive Symptoms, Nutrition, Healthy, Quality of Life, Eating Behavior, Work-Related Condition
- Being tested
- Mind Nutrition
- Keywords
- Depressive Symptoms, Nutrient intake, Work ability, Quality of Life, Randomized, controlled trial, Nutritional counseling
- Medical subject headings
- Depression, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind NutritionBehavioural
The 6-month nutrition intervention includes two individual and three group dietary counseling sessions. During the first individual meeting, a research dietitian will assess the participants' diet quality and eating habits, and each participant will set personal goals in cooperation with the research dietitian. At the second individual meeting, the attainment of the goals will be evaluated, and potential challenges and solutions discussed. Each group session has its theme and content in the following chronological order:
- Introduction to the theme and importance of a regular meal frequency
- Principals of health-promoting diet, mindful eating
- Successful eating regulation skills, psychology of the long-term lifestyle changes.
Additionally, participants receive home assignments and a workbook containing informational material and exercises.
| Study group | Role | What they receive |
|---|---|---|
| "Mind Nutrition" Nutritional counseling | Experimental | The intervention arm includes five dietary counseling sessions during 6 months. Receives: Behavioral: Mind Nutrition |
| Control | No intervention | The control arm does not include any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptoms
Change in depressive symptoms measured with the Center for Epidemiological Studies - Depression (CES-D) questionnaire. It has 20 questions with response options from 0 to 3 points. Possible scores are between 0-60 with higher scores meaning more severe depression symptomology.
Measured: 6 months
Change in work ability
Change in work ability measured with a three-step work ability indicator created by the Finnish Institute for Health and Welfare: "Regardless of whether you are employed or not, please estimate your current work ability." The answer options are coded in three different categories: 1) completely fit for work (2 points), 2) partially unable to work (1 point), and 3) completely unable to work (0 points)."
Measured: 6 months
Change in depressive symptoms-related sick leave days
Change in the number of depressive symptoms-related sick leave days assessed with a structured question.
Measured: 6 months
Secondary outcomes (4)
Change in quality of life
Change in quality of life measured with the World Health Organization Eurohis-QOL (WHO8-EUROHIS) questionnaire. It has eight items with a 5-point response format on a Likert scale. The total score is obtained by summing the eight items and dividing the result by eight, meaning that the possible scores are between 1-5. Higher scores indicate better life quality.
Measured: 6 months
Change in dietary habits
Change in dietary habits assessed with a 163-item Food frequency questionnaire (FFQ) created by the University of Eastern Finland and the Baltic Sea Diet Score derived from the FFQ data. The FFQ comprises nine frequency response options which are multiplied by the portion sizes (grams) to obtain consumption of each listed food item. Average daily food, nutrient, and energy intakes are calculated using the Finnish National Food Composition (Fineli®) database. The Finnish Healthy Diet Index (HDI) score will be derived from the data. Scores range from 0 to 100, with higher scores meaning better diet quality.
Measured: 6 months
Change in energy and nutrient intake
Change in energy and nutrient intake measured with three-day food records utilizing the Eat@Work mobile application by the Satakunta University of Applied Sciences.
Measured: 6 months
Change in eating behavior
Change in Eating behavior assessed by the Three Factor Eating Questionnaire - 18 (TFEQ-18). Its three domains (emotional eating, uncontrolled eating, and cognitive restraint) are measured with 18 questions. Raw scores are scaled to 0-100 points, with higher scores meaning a stronger tendency for each behavior domain.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Sep 2024 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects in the intervention group participate in a 6-month nutrition counseling program, including two individual and three group-based sessions. The content of the sessions is described in the "Arms and Interventions" section. The behavioral intervention utilizes theoretical frameworks of goal attainment, psychoeducation, peer support, motivational interviewing, mindfulness, and flexible eating restraint.
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Satakunta University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susanna Kunvik, PhD, Principal investigator, Senior Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448117
- Sponsor's protocol ID
- 30102023
- Status last verified
- Sep 2024
- First submitted
- 3 Jun 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind Nutrition Study. Effectiveness of Improving Nutrition on Depressive Symptoms and Work Ability
- ClinicalTrials.gov ID
- NCT06448117
- Acronym / sponsor ID
- 30102023
- Conditions
- Depressive Symptoms, Nutrition, Healthy, Quality of Life, Eating Behavior, Work-Related Condition
- Keywords
- Depressive Symptoms, Nutrient intake, Work ability, Quality of Life, Randomized, controlled trial, Nutritional counseling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Satakunta University of Applied SciencesUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized, controlled trial is to examine the effectiveness of dietary counseling on depressive symptoms, work ability, and quality of life in mental health and substance abuse professionals. The main questions it aims to answer are:
- Whether dietary counseling can lower depressive symptoms and depressive symptoms-related sick leave days and improve work ability among mental health and substance abuse professionals
- Whether dietary counseling can improve life quality, diet quality, and eating behavior among mental health and substance abuse professionals.
Subjects of the intervention group will participate in five dietary counseling sessions during six months. Participants in the control group do not receive any intervention.
Researchers will compare the intervention and control groups to see if dietary counseling is effective in reducing the risk of depressiveness and depression-related sick leave days and improving work ability, quality of life, and nutritional habits.
Detailed description
Background. Depressive disorders are a growing public health concern. Depression is linked to increases in work absenteeism, short-term disability, decreased productivity, and presenteeism and has become a global public health challenge. The association between nutrition and the risk of depressiveness is recognized, but there are no published randomized, controlled whole-diet intervention studies with the main aim of depression prevention. It is essential to investigate the impact of nutrition counseling on symptoms of depression in high-risk groups.
Aims. This Mind Nutrition randomized, controlled trial is part of the Mind Nutrition study that combines the intervention part and a cross-sectional examination that utilizes a separate dataset. The primary aim of the intervention study is to examine whether improving nutrition can (cost-effectively) reduce depressive symptoms and related sick leave and enhance work ability. Secondary aims are to measure the effects of the intervention on diet quality, life quality, and eating behavior, evaluate the attainment of participants' personal goals, and assess the acceptability of the intervention.
Methods. The randomized, controlled trial examines the effectiveness of six-month nutritional counseling on depressive symptoms and work ability among practical and registered nurses and social welfare professionals (n=125) working in the mental health and substance abuse field of the Satakunta wellbeing services county. Half of the participants are randomized into the intervention group and half into the control group. The six-month intervention includes two individual and three group counseling sessions. The control group will not receive any intervention but, instead, continue their habitual diet. The investigators measure the outcomes utilizing questionnaires and three-day food records at baseline and the end of the intervention. Weight and blood pressure will be measured at the same time points.
Discussion. This study will provide nationally and internationally crucial evidence on the effectiveness of nutrition counseling on depressive symptoms, work ability, and quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects in the intervention group participate in a 6-month nutrition counseling program, including two individual and three group-based sessions. The content of the sessions is described in the "Arms and Interventions" section. The behavioral intervention utilizes theoretical frameworks of goal attainment, psychoeducation, peer support, motivational interviewing, mindfulness, and flexible eating restraint.
| Arm | Type | Receives |
|---|---|---|
| "Mind Nutrition" Nutritional counseling | Experimental | Behavioral: Mind NutritionThe intervention arm includes five dietary counseling sessions during 6 months. |
| Control | No intervention | –The control arm does not include any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged at least 18 year
- Adequate Finnish language skills
- Work-capable
- Currently employed by Satakunta wellbeing services county for at least 6 months
- Works in the field of mental health and substance abuse
Key exclusion criteria (6 listed)
- Acute mental health symptoms and incapable to work
- Terminal phase disease or unstable severe chronic disease (consultation of the doctor in charge)
- Employed for a shorter period than 6 months
- Has a history of an eating disorder (consultation of the doctor in charge)
- Center for Epidemiological Studies - Depression (CES-D) score ≥16 and reduced work capacity (presenteeism) (consultation of the medical expert in mental health)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mind NutritionThe 6-month nutrition intervention includes two individual and three group dietary counseling sessions. During the first individual meeting, a research dietitian will assess the participants' diet quality and eating habits, and each participant will set personal goals in cooperation with the research dietitian. At the second individual meeting, the attainment of the goals will be evaluated, and potential challenges and solutions discussed. Each group session has its theme and content in the following chronological order: 1. Introduction to the theme and importance of a regular meal frequency 2. Principals of health-promoting diet, mindful eating 3. Successful eating regulation skills, psychology of the long-term lifestyle changes. Additionally, participants receive home assignments and a workbook containing informational material and exercises. | Behavioural | "Mind Nutrition" Nutritional counseling |
Primary outcome
Change in depressive symptoms
Time frame: 6 months
Change in depressive symptoms measured with the Center for Epidemiological Studies - Depression (CES-D) questionnaire. It has 20 questions with response options from 0 to 3 points. Possible scores are between 0-60 with higher scores meaning more severe depression symptomology.
Change in work ability
Time frame: 6 months
Change in work ability measured with a three-step work ability indicator created by the Finnish Institute for Health and Welfare: "Regardless of whether you are employed or not, please estimate your current work ability." The answer options are coded in three different categories: 1) completely fit for work (2 points), 2) partially unable to work (1 point), and 3) completely unable to work (0 points)."
Change in depressive symptoms-related sick leave days
Time frame: 6 months
Change in the number of depressive symptoms-related sick leave days assessed with a structured question.
4 secondary outcomes
Change in quality of life
Time frame: 6 months
Change in dietary habits
Time frame: 6 months
Change in energy and nutrient intake
Time frame: 6 months
Change in eating behavior
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanna Kunvik, PhD principal investigator
Senior Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind Nutrition in people with Depressive Symptoms and Nutrition, Healthy, run by Satakunta University of Applied Sciences at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susanna Kunvik, PhD (+358447103204, susanna.kunvik@samk.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive symptoms (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.