Nursing Intervention in Weight and Metabolic Syndrome Management in First-episode Psychosis (MetaKOP)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorHospital de Basurto
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Nursing Consultation in Weight Management and Metabolic syndrome
Treatment groups
88 Participants
are divided into 2 treatment groupsSponsors and collaborators
Hospital de Basurto
Lead sponsor
Euskal Herriko Unibertsitatea. Universidad del Pais Vasco.
Collaborator
Instituto Vasco de Investigación Sanitaria (BIOEF)
Collaborator
Source ClinicalTrials.gov