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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Nursing Consultation in Weight Management and Metabolic syndrome
BehavioralBased on the Carbohydrate-insulin Theory
Treatment groups
88 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Weight
Weight in kilograms
Time frame
From enrollment to the end of treatment at 48 weeksSecondary outcomes
1
Metabolic Syndrome
According to the International Diabetes Federation (IDF)
Time frame
From enrollment to the end of treatment at 48 weeks2
Psychopathology
measured using PANSS scale
Time frame
From enrollment to the end of treatment at 48 weeks3
Depressive symptoms
measured by Hamilton Depression Rating Scale
Time frame
From enrollment to the end of treatment at 48 weeks4
Qualit of Life
EuroQoL 5D scale will be used
Time frame
From enrollment to the end of treatment at 48 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital de Basurto
Lead sponsor
Euskal Herriko Unibertsitatea. Universidad del Pais Vasco.
Collaborator
Instituto Vasco de Investigación Sanitaria (BIOEF)
Collaborator
Source ClinicalTrials.gov