Ireland
--:--IST
Recruiting Not applicable

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

NCT06650943 · tracked via the Priya Life Science Spain tracker
Sponsor
Hospital de Basurto
Phase
Not applicable
Started
2023-10-25
Last updated
2024-10-22

Condition(s) studied

First Episode Psychosis (FEP)Metabolic Syndrome X

Investigational drug(s) / intervention(s)

Nursing Consultation in Weight Management and Metabolic syndrome

Nursing Consultation in Weight Management and Metabolic syndrome: Based on the Carbohydrate-insulin Theory

Study summary

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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patients admitted to the Early Intervention Program (EIP). 2. First-episode psychosis (FEP) within the last 5 years. 3. Diagnosis of psychosis from the F2 spectrum or an affective disorder with psychotic symptoms according to ICD-10. Exclusion Criteria: 1. Cognitive inability to learn or comorbid intellectual disability that interferes with study procedures. 2. Comorbid diagnosis of neurological pathology. 3. Language or comprehension impairments preventing accurate data collection. 4. Use of hypoglycemic medication before or during the study. 5. Refusal to participate

Primary outcome measure(s)

  • Weight — From enrollment to the end of treatment at 48 weeks
    Weight in kilograms

Trial sites (1)

FacilityCityRegionStatus
Hospital Universitario Basurto Bilbao Vizcaya Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06650943 on ClinicalTrials.gov ↗ ← All trials in Spain