Mind Nutrition Study. Effectiveness of Improving Nutrition on Depressive Symptoms and Work Ability

NCT06448117 | Not Yet Recruiting

• 1 other identifier: 30102023
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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)."

  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.

  6 months

Secondary Outcomes (4)

• Change in quality of life

  6 months

• Change in dietary habits

  6 months

• Change in energy and nutrient intake

  6 months

• Change in eating behavior

  6 months

Study Arms (2)

"Mind Nutrition" Nutritional counseling

EXPERIMENTAL

The intervention arm includes five dietary counseling sessions during 6 months.

Behavioral: Mind Nutrition

Control

NO INTERVENTION

The control arm does not include any intervention.

Interventions

Mind Nutrition BEHAVIORAL

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: 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.

"Mind Nutrition" Nutritional counseling

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Satakunta University of Applied Sciences: lead

Study Sites (1)

Satakunta University of Applied Sciences

Pori, Satakunta, 28130, Finland

Location

MeSH Terms

Conditions

Depression; Feeding Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Behavior, Animal

Study Officials

• Susanna Kunvik, PhD

  Senior Researcher

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susanna Kunvik, PhD

CONTACT

+358447103204; susanna.kunvik@samk.fi

Aino Kipfer, MSc

CONTACT

+358505678410; aino.kipfer@samk.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: September 1, 2024
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)