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NCT Number: NCT06650943

Nursing Intervention in Weight and Metabolic Syndrome Management in First-episode Psychosis (MetaKOP)

The goal of this clinical trial is to evaluate if a nursing intervention based on the carbohydrate-insulin model can effectively reduce weight and manage the risk of metabolic syndrome (MetS) in individuals with first-episode psychosis. The main questions it aims to answer are:

Will the intervention lead to a clinically significant weight loss (≥5%)? Can the intervention improve metabolic parameters, psychopathological state, physical activity level, and quality of life? Researchers will compare participants receiving the specialized nursing consultations to those receiving routine care to see if the former group experiences greater improvements in weight loss and metabolic risk reduction.

Participants will:

Attend a series of 8 nursing consultations focused on dietary habits based on the carbohydrate-insulin model and physical activity.

Complete assessments at the start, 6 months, and 12 months, including weight, metabolic parameters, and psychological evaluations.

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Key information

Conditions

First Episode Psychosis (FEP) Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Mental Disorders Metabolic Diseases Metabolic Syndrome Metabolic Syndrome X Nutritional and Metabolic Diseases Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Basurto

Bilbao, Vizcaya, 48013, Spain

Location status: Recruiting

Location contact

Lander Madaria

CONTACT

[email protected]

646179740

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients admitted to the Early Intervention Program (EIP).
  • First-episode psychosis (FEP) within the last 5 years.
  • Diagnosis of psychosis from the F2 spectrum or an affective disorder with psychotic symptoms according to ICD-10.

Exclusion criteria

  • Cognitive inability to learn or comorbid intellectual disability that interferes with study procedures.
  • Comorbid diagnosis of neurological pathology.
  • Language or comprehension impairments preventing accurate data collection.
  • Use of hypoglycemic medication before or during the study.
  • Refusal to participate

Treatment and study plan

Nursing Consultation in Weight Management and Metabolic syndrome

Behavioral

Based on the Carbohydrate-insulin Theory

Primary outcomes

  1. Weight

    Time frame: From enrollment to the end of treatment at 48 weeks

    Weight in kilograms

Secondary outcomes

  1. Metabolic Syndrome

    Time frame: From enrollment to the end of treatment at 48 weeks

    According to the International Diabetes Federation (IDF)

  2. Psychopathology

    Time frame: From enrollment to the end of treatment at 48 weeks

    measured using PANSS scale

  3. Depressive symptoms

    Time frame: From enrollment to the end of treatment at 48 weeks

    measured by Hamilton Depression Rating Scale

  4. Qualit of Life

    Time frame: From enrollment to the end of treatment at 48 weeks

    EuroQoL 5D scale will be used

  5. Reported phisical activity

    Time frame: From enrollment to the end of treatment at 48 weeks

    International Physical Activity Questionnaire (IPAQ)

Study contacts

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

Lander Madaria

CONTACT

[email protected]

646179740

Sponsors and collaborators

Lead sponsor

Hospital de Basurto

Other

Collaborators

  • Euskal Herriko Unibertsitatea. Universidad del Pais Vasco.
  • Instituto Vasco de Investigación Sanitaria (BIOEF)

Registry information

Official study title

Efficacy Study on Nursing Consultation in Weight and Metabolic Syndrome Management Based on the Carbohydrate-insulin Theory in Individuals with First-episode Psychosis (MetaKOP)

Acronym: MetaKOP

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 21, 2024
Registry last updated
Oct 22, 2024

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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