NCT07844837

Brief Summary

This study aimed to investigate the associations of ultra-processed food (UPF) consumption and DASH diet adherence with psychological well-being, emotional eating, and inflammatory markers in individuals with severe mental illness (SMI). This cross-sectional study included clinically stable individuals aged 18-65 years who had been diagnosed with a psychiatric disorder according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) or the International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10). Participants were selected using purposive sampling. Data were collected face-to-face using a Sociodemographic Information Form, the Screening Questionnaire of Highly Processed Food Consumption (SQ-HPF), the Dietary Approaches to Stop Hypertension Quality (DASH-Q), the Psychological Well-Being Scale, and the Emotional Eating Scale. Anthropometric measurements and routine biochemical data, including fasting glucose, C-reactive protein (CRP), and complete blood count parameters, were recorded.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 7, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 28, 2026

Completed
Last Updated

September 28, 2026

Status Verified

September 1, 2026

Enrollment Period

4 months

First QC Date

September 7, 2026

Last Update Submit

September 24, 2026

Conditions

Outcome Measures

Primary Outcomes (14)

  • Questionnaire Form

    Sociodemographic characteristics of the individuals (age, constipation status, presence of comorbidities, gender, smoking and alcohol use) were questioned.

    4 months

  • Body weight (BW)

    BW was measured using a calibrated digital scale placed on a flat, tiled surface. The scale was sensitive to 100 grams.

    4 months

  • Height

    Height was measured using a stadiometer with the participant's head positioned in the Frankfort plane and feet placed together.

    4 months

  • Body Mass Index (BMI)

    BMI was calculated by dividing body weight (in kilograms) by the square of height (in meters): BMI = weight (kg) / height² (m²).

    4 months

  • C-Reactive Protein (CRP)

    CRP levels were measured using routine laboratory procedures in outpatient visits.

    4 months

  • Hemoglobin (Hb)

    Hemoglobin (Hb) levels were measured using routine laboratory procedures in outpatient visits.

    4 months

  • Neutrophil

    Neutrophil levels were measured using routine laboratory procedures in outpatient visits.

    4 months

  • Lymphocyte

    Lymphocyte levels were measured using routine laboratory procedures in outpatient visits.

    4 months

  • Systemic immune-inflammation index (SII)

    Systemic immune-inflammation index (SII)

    4 months

  • Neutrophil-to-lymphocyte ratio (NLR)

    The neutrophil-to-lymphocyte ratio (NLR), a hematological marker of systemic inflammation, was calculated by dividing the absolute neutrophil count by the absolute lymphocyte count.

    4 months

  • The Screening Questionnaire of Highly Processed Food Consumption (SQ-HPF)

    The Screening Questionnaire of Highly Processed Food Consumption (SQ-HPF) is a brief dietary assessment tool developed to evaluate the frequency of consumption of highly processed foods. The questionnaire assesses the consumption of various food groups commonly classified as highly processed and provides an overall score reflecting the frequency of highly processed food consumption. sQ-HPF is an 11-item dietary screening tool used to assess highly processed food consumption. Each item is scored as 0 or 1, yielding a total score ranging from 0 to 11. Higher scores indicate higher consumption of highly processed foods and therefore a worse outcome. A total score of 6 or higher indicates a high level of highly processed food consumption.

    4 months

  • The Dietary Approaches to Stop Hypertension Quality (DASH-Q)

    The Dietary Approaches to Stop Hypertension Quality (DASH-Q) is a dietary assessment tool designed to evaluate adherence to the Dietary Approaches to Stop Hypertension (DASH) dietary pattern. The scale assesses the consumption of key food groups and nutrients emphasized in the DASH diet, with higher scores indicating greater adherence to the DASH dietary pattern. DASH-Q is an 11-item dietary assessment tool designed to evaluate adherence to the DASH dietary pattern. Each item is scored from 0 to 7 according to the number of days the corresponding food group was consumed during the previous 7 days, yielding a total score ranging from 0 to 77. Total scores are classified as low (0-32), moderate (33-51), or high (52-77) diet quality. Higher scores indicate greater adherence to the DASH dietary pattern and therefore represent a better outcome.

    4 months

  • Emotional Eating Scale (EES)

    The Emotional Eating Scale (EES) is a self-report instrument designed to assess the tendency to eat in response to emotional states. It evaluates eating behavior associated with various emotional states, with higher scores indicating a greater tendency toward emotional eating. EES is a 16-item scale consisting of three subscales: anger, anxiety, and depression. Each item is rated on a 5-point Likert scale ranging from 1 (no desire to eat) to 5 (an overwhelming urge to eat). There are no reverse-scored items. The total score ranges from 16 to 80, with higher scores indicating a higher level of emotional eating behavior and therefore a worse outcome.

    4 months

  • Psychological Well-being Scale

    The Psychological Well-Being Scale is a self-report instrument designed to assess individuals' overall psychological well-being and positive psychological functioning. Higher scores indicate higher levels of psychological well-being.The Psychological Well-Being Scale is an 8-item scale designed to assess individuals' psychological well-being. Each item is rated on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). The total score ranges from 8 to 56, with higher scores indicating greater psychological resources and strengths and a more positive evaluation of oneself in important areas of functioning, therefore representing a better outcome.

    4 months

Study Arms (1)

Participants with severe mental illness

This study included 105 adult participants with severe mental illness. No control group was included.

Other: No intervention (observational study)

Interventions

No intervention (observational study)

Participants with severe mental illness

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consisted of adults aged 18-65 years with a psychiatric disorder confirmed according to DSM-5 or ICD-10 diagnostic criteria. Participants were clinically stable and had been receiving treatment for at least 1 month. A total of 105 participants were initially included in the study, while 92 participants were included in the final analyses after excluding those with incomplete data. No control group was included.

You may qualify if:

  • Aged 18-65 years
  • Having a psychiatric disorder confirmed according to DSM-5 or ICD-10 diagnostic criteria
  • Being clinically stable
  • Having received treatment for at least 1 month

You may not qualify if:

  • Severe cognitive impairment or a diagnosis of dementia
  • Experiencing an acute psychiatric crisis
  • Pregnancy or breastfeeding
  • Having a medical condition that severely restricts dietary intake (e.g., renal failure or ongoing cancer treatment)
  • A history of major surgery within the previous 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolu Abant İzzet Baysal University, Faculty of Health Sciences

Bolu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Mental Disorders

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Nurefşan Konyalıgil Öztürk

    Abant Izzet Baysal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof. Dr

Study Record Dates

First Submitted

September 7, 2026

First Posted

September 28, 2026

Study Start

April 1, 2026

Primary Completion

August 1, 2026

Study Completion

August 1, 2026

Last Updated

September 28, 2026

Record last verified: 2026-09

Locations