Mind Nutrition Study: Nutrition in the Prevention of Depressiveness and Sustaining Work Ability

Quality of Life Clinical Trial

Official title:

Mind Nutrition Study: Nutrition in the Prevention of Depressiveness and Sustaining Work Ability

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06448117
• Other study ID #: 30102023
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: August 31, 2025

Study information

• Verified date: June 2024
• Source: Satakunta University of Applied Sciences
• Contact: Susanna Kunvik, PhD
• Phone: +358447103204
• Email: susanna.kunvik[@]samk.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this randomized, controlled trial is to examine the effectiveness of dietary counseling on the risk of depressiveness, work ability, and quality of life in mental health professionals. The main questions it aims to answer are:

• Whether dietary counseling can lower the risk of depression and depression-related sick leave days and improve work ability among mental health professionals

• Whether dietary counseling can improve life quality, diet quality, and eating behavior among mental health 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.

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) prevent depression symptoms and depression-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 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. We 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 in depression prevention, work ability, and quality of life.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• Eating Behavior
• Quality of Life
• Work-Related Condition

Intervention

Behavioral:
• Mind Nutrition
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.

Locations

Country	Name	City	State
Finland	Satakunta University of Applied Sciences	Pori	Satakunta

Sponsors (1)

Lead Sponsor	Collaborator
Satakunta University of Applied Sciences

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the risk of depressiveness	Change in the risk of depressiveness measured with the Center for Epidemiological Studies - Depression (CES-D) questionnaire.	6 months
Primary	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.	6 months
Primary	Change in depression-related sick leave days	Change in the number of depression-related sick leave days assessed with a structured question.	6 months
Secondary	Change in quality of life	Change in quality of life measured with the World Health Organization Eurohis-QOL (WHO8-EUROHIS) questionnaire.	6 months
Secondary	Change in dietary habits	Change in dietary habits assessed with a Food frequency questionnaire created by the University of Eastern Finland.	6 months
Secondary	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.	6 months
Secondary	Change in eating behavior	Change in Eating behavior assessed by the Three Factor Eating Questionnaire - 18 (TFEQ-18).	6 months