ClinicalTrials.gg
RecruitingNCT07411222Updated Jul 27, 2026

Emotional Eating, Sleep Quality, Mental State and Metabolic Syndrome

An observational study in Schizophrenia, Bipolar Disorder and Psychiatric Issue, sponsored by Abant Izzet Baysal University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-27.

Sponsored by Abant Izzet Baysal University · Observational

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
78
Ages
18 Years to 65 Years
Sex
All
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Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Schizophrenia
  • Bipolar Disorder
  • Psychiatric Issue
  • Metabolic Syndrome
  • Emotional Eating
  • Sleep
  • Mediating

Keywords

  • Schizophrenia
  • Bipolar Disorder
  • Metabolic Syndrome
  • Emotional Eating
  • Sleep
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In context

Schizophrenia

3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.

This study's planned enrollment of 78 is below the median of 178 across 506 observational studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Abant Izzet Baysal University is the lead sponsor of 250 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Individuals being followed at the Community Mental Health Center, diagnosed with schizophrenia or bipolar disorder, who volunteered to participate in the study and were able to provide written consent.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Having a diagnosis of mental retardation,
  • Having other neurocognitive disorders, primarily dementia, according to (as it can affect the ability to make decisions and give correct answers),
  • Not being able to speak or understand Turkish.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
78 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Metabolic Syndrome Risk

    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.

    Time frame: Baseline

Secondary outcomes

  1. Emotional eating level

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

    Time frame: Baseline

  2. Sleep quality

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

    Time frame: Baseline

  3. Positive and negative symptom

    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.

    Time frame: Baseline

  4. Manic symptom

    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.

    Time frame: Baseline

  5. Depressive symptoms

    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.

    Time frame: Baseline

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • Zhang W, Sun Q, Chen B, Basta M, Xu C, Li Y. Insomnia symptoms are associated with metabolic syndrome in patients with severe psychiatric disorders. Sleep Med. 2021 Jul;83:168-174. doi: 10.1016/j.sleep.2021.03.030. Epub 2021 May 19. PubMed 34022493 ↗
  • Zeron-Rugerio MF, Doblas-Faxeda S, Diez-Hernandez M, Izquierdo-Pulido M. Are Emotional Eating and Other Eating Behaviors the Missing Link in the Relationship between Inadequate Sleep and Obesity? A Systematic Review. Nutrients. 2023 May 12;15(10):2286. doi: 10.3390/nu15102286. PubMed 37242168 ↗
  • Yan H, Huang Z, Lu Y, Qiu Y, Li M, Li J. Associations between metabolic disorders and sleep disturbance in patients with schizophrenia. Compr Psychiatry. 2023 Apr;122:152369. doi: 10.1016/j.comppsych.2023.152369. Epub 2023 Jan 21. PubMed 36702060 ↗
  • Leutner M, Dervic E, Bellach L, Klimek P, Thurner S, Kautzky A. Obesity as pleiotropic risk state for metabolic and mental health throughout life. Transl Psychiatry. 2023 May 30;13(1):175. doi: 10.1038/s41398-023-02447-w. PubMed 37248222 ↗
  • Laaboub N, Dubath C, Ranjbar S, Sibailly G, Grosu C, Piras M, Delessert D, Richard-Lepouriel H, Ansermot N, Crettol S, Vandenberghe F, Grandjean C, Delacretaz A, Gamma F, Plessen KJ, von Gunten A, Conus P, Eap CB. Insomnia disorders are associated with increased cardiometabolic disturbances and death risks from cardiovascular diseases in psychiatric patients treated with weight-gain-inducing psychotropic drugs: results from a Swiss cohort. BMC Psychiatry. 2022 May 17;22(1):342. doi: 10.1186/s12888-022-03983-3. PubMed 35581641 ↗
  • Dakanalis A, Mentzelou M, Papadopoulou SK, Papandreou D, Spanoudaki M, Vasios GK, Pavlidou E, Mantzorou M, Giaginis C. The Association of Emotional Eating with Overweight/Obesity, Depression, Anxiety/Stress, and Dietary Patterns: A Review of the Current Clinical Evidence. Nutrients. 2023 Feb 26;15(5):1173. doi: 10.3390/nu15051173. PubMed 36904172 ↗
  • Godet A, Fortier A, Bannier E, Coquery N, Val-Laillet D. Interactions between emotions and eating behaviors: Main issues, neuroimaging contributions, and innovative preventive or corrective strategies. Rev Endocr Metab Disord. 2022 Aug;23(4):807-831. doi: 10.1007/s11154-021-09700-x. Epub 2022 Jan 4. PubMed 34984602 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07411222
Responsible party
Melisa BULUT (Research Assistant PhD, Abant Izzet Baysal University) — Principal investigator
First posted
Feb 13, 2026
Start date
May 30, 2026
Primary completion
Oct 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jul 27, 2026

Study contacts

Melisa Bulut, PhD
Contact
melisa.bulut@ibu.edu.tr
+905348855882
Nur Özgedik Turhan, Psychiatrist
Contact
drnurozgedik@gmail.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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