Efficacy Study on Nursing Consultation in Weight and Metabolic Syndrome Management Based on the Carbohydrate-insulin Theory in Individuals with First-episode Psychosis (MetaKOP)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 88
- Locations
- 2
- Primary Endpoint
- Weight
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
The psychometric scale evaluators will be blinded.
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Weight
Time Frame: From enrollment to the end of treatment at 48 weeks
Weight in kilograms
Secondary Outcomes
- Metabolic Syndrome(From enrollment to the end of treatment at 48 weeks)
- Psychopathology(From enrollment to the end of treatment at 48 weeks)
- Depressive symptoms(From enrollment to the end of treatment at 48 weeks)
- Qualit of Life(From enrollment to the end of treatment at 48 weeks)
- Reported phisical activity(From enrollment to the end of treatment at 48 weeks)
Investigators
Lander Madaria Marijuan
Mental Health Nurse Specialist
Hospital de Basurto