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Recruiting NCT07411222

Emotional Eating, Sleep Quality, Mental State and Metabolic Syndrome

Observational Schizophrenia Bipolar Disorder Psychiatric Issue Metabolic Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Schizophrenia, Bipolar Disorder, Psychiatric Issue, Metabolic Syndrome. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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.

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.

Primary outcome measures

  • Metabolic Syndrome Risk [Time frame: Baseline]
Secondary outcome measures (5)
  • Emotional eating level [Time frame: Baseline]
  • Sleep quality [Time frame: Baseline]
  • Positive and negative symptom [Time frame: Baseline]
  • Manic symptom [Time frame: Baseline]
  • Depressive symptoms [Time frame: Baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Turkey (Türkiye) · 1 center
  • Melisa Bulut — Bolu

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. PMID 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. PMID 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. PMID 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. PMID 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 psych PMID 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. PMID 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. PMID 34984602

Identifiers

NCT: NCT07411222 · AIBU-PSK-MB-04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗