Clinical trial NCT06448117: Mind Nutrition Study. Effectiveness of Improving Nutrition on Depressive Symptoms and Work Ability
Official title: Mind Nutrition Study. Effectiveness of Improving Nutrition on Depressive Symptoms and Work Ability
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Satakunta University of Applied Sciences
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in depressive symptoms
timeFrame: 6 months
measure: Change in work ability
timeFrame: 6 months
measure: Change in depressive symptoms-related sick leave days
timeFrame: 6 months
Secondary outcomes:
measure: Change in quality of life
timeFrame: 6 months
measure: Change in dietary habits
timeFrame: 6 months
measure: Change in energy and nutrient intake
timeFrame: 6 months
measure: Change in eating behavior
timeFrame: 6 months
Other outcomes:
Locations:
city: Pori
country: Finland
facility: Satakunta University of Applied Sciences
state: Satakunta
Study officials:
affiliation: Senior Researcher
name: Susanna Kunvik, PhD
role: PRINCIPAL_INVESTIGATOR
References: