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NCT Number: NCT07411222

Emotional Eating, Sleep Quality, Mental State and Metabolic Syndrome

In predominantly medication-naïve schizophrenic patients, those exhibiting partial metabolic disorders have significantly worse sleep quality and sleep onset time; poor sleep predicted metabolic dysregulation even after controlling for confounding factors. Mental health, sleep, and eating behavior interact in ways that strongly influence the risk of obesity and MetS. Emotional eating (eating in response to emotions rather than hunger) is central to this network and appears to be closely associated with psychiatric illnesses, particularly depression, anxiety, and sleep disorders. There is a continuing need to elucidate the frequency, level, and relationship of emotional eating with other factors in individuals with SMI. Therefore, this study aims to elucidate this complex relationship, thereby shedding light on new ways to reduce metabolic risks in psychiatric patients.

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Key information

Conditions

Schizophrenia Behavior Bipolar Disorder Bipolar and Related Disorders Communication Emotional Eating Feeding Behavior Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Mediating Mental Disorders Metabolic Diseases Metabolic Syndrome Mood Disorders Negotiating Nutritional and Metabolic Diseases Psychiatric Issue Schizophrenia Spectrum and Other Psychotic Disorders Sleep

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Melisa Bulut

Bolu, 141000, Turkey (Türkiye)

Location status: Recruiting

Location contact

Melisa Bulut, PhD

CONTACT

[email protected]

Nur Özgedik Turhan, psychiatrist

SUB_INVESTIGATOR

About this study

Research Questions

  • Is there a relationship between mental status and MetS in individuals with SMI?
  • How does diagnosis (schizophrenia or bipolar disorder) and the group of medications used affect MetS in individuals with SMI?
  • What is the level of emotional eating in individuals with SMI?
  • Do emotional eating and sleep quality affect MetS in relation to mental status in individuals with SMI?

Hypotheses

H1 The group of psychotropic medications routinely used significantly affects MetS levels.

H2 Individuals with SMI have high levels of emotional eating.

H3 As mental status deteriorates, the level of emotional eating increases.

H4 Emotional eating mediates the relationship between mental status and MetS.

H5 Sleep quality mediates the relationship between mental status and MetS.

H6 Emotional eating and sleep quality mediate the relationship between mental status and MetS (multiple mediation model).

H7 As sleep quality decreases, emotional eating increases.

H8 As the level of emotional eating increases, sleep quality deteriorates, which increases the risk of metabolic syndrome.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being registered with the Bolu İzzet Baysal Mental Health and Diseases Hospital Community Mental Health Center,
  • Having a severe chronic psychiatric illness (Schizophrenia Spectrum and Other Psychotic Disorders and Bipolar Disorder) followed by the Bolu İzzet Baysal Mental Health and Diseases Hospital Community Mental Health Center for at least 6 months,
  • Being in remission (Complete Remission (Pre-Remission): Symptoms remaining below threshold values for at least 2 months (8 weeks). A state of improvement lasting more than 2 months is generally referred to as "remission"),
  • Schizophrenia remission definition: 8 diagnostically significant symptoms were selected from the Positive and Negative Syndrome Scale.
  • Bipolar disorder remission definition: Complete remission is defined as the absence of acute attacks and the presence of minimal/very mild symptoms.
  • Being between 18-65 years of age,
  • Being able to understand what is read and give written consent.

Exclusion criteria

  • Having a diagnosis of mental retardation,
  • Having other neurocognitive disorders, primarily dementia, according to DSM-V (as it can affect the ability to make decisions and give correct answers),
  • Not being able to speak or understand Turkish.

Treatment and study plan

Primary outcomes

  1. Metabolic Syndrome Risk

    Time frame: Baseline

    Participants' current metabolic syndrome risk scores will be measured using the Metabolic Syndrome Risk Index. The total score ranges from 0 to 100. A higher score indicates a higher risk of metabolic syndrome risk.

Secondary outcomes

  1. Emotional eating level

    Time frame: Baseline

    Participants' current emotional eating level scores will be measured using the Salzburg Emotional Eating Scale.

  2. Sleep quality

    Time frame: Baseline

    Participants' current sleep quality scores will be measured using the Cumhuriyet Subjective Sleep Quality Scale.

  3. Positive and negative symptom

    Time frame: Baseline

    Participants' current positive and negative symptom severity. This will be measured using Positive and Negative Syndrome Scale (PANSS). It measures the prevalence of positive and negative syndromes in schizophrenia. Scores range from 7-49 for the Positive and Negative Scales, and from 16-112 for the General Psychopathology Scale. The PANSS total score is a minimum of 30 and a maximum of 210. A higher score indicates higher symptom severity.

  4. Manic symptom

    Time frame: Baseline

    Participants' current manic symptom severity. This will be measured using Young Mania Rating Scale. It measures the prevalence of manic symptom in bipolar disorders. The total score can range from 0 to 60; higher scores indicate more severe manic symptoms.

  5. Depressive symptoms

    Time frame: Baseline

    Participants' current depressive symptoms severity. This will be measured using Hamilton Depression Rating Scale. It measures the prevalence of depressive symptom. In general, the higher the total score, the more severe the depression. HAM-D depression score levels: 10-13 mild; 14-17 mild to moderate; >17 moderate to severe; >23 very severe. Total score ranges from 0 to 68.

Study contacts

Contact information is provided by the study sponsor or research team.

Melisa Bulut, PhD

CONTACT

[email protected]

+905348855882

Nur Özgedik Turhan, Psychiatrist

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Official study title

The Mediating Role of Emotional Eating and Sleep Quality in the Relationship Between Mental State and Metabolic Syndrome in Individuals With Schizophrenia and Bipolar Disorder

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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