Nursing Intervention in Weight and Metabolic Syndrome Management in First-episode Psychosis (MetaKOP)
Recruiting · NCT06650943 · Interventional (participants receive a specific treatment) · Lead sponsor: Hospital de Basurto
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed.
- Hospital Universitario Basurto - Bilbao, Vizcaya, Spain