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Efficacy Study on Nursing Consultation in Weight and Metabolic Syndrome Management Based on the Carbohydrate-insulin Theory in Individuals with First-episode Psychosis (MetaKOP)
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.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Hospital Universitario Basurto
Bilbao, Vizcaya, Spain
Start Date
October 25, 2023
Primary Completion Date
June 30, 2026
Completion Date
June 30, 2026
Last Updated
October 22, 2024
88
ESTIMATED participants
Nursing Consultation in Weight Management and Metabolic syndrome
BEHAVIORAL
Lead Sponsor
Hospital de Basurto
Collaborators
NCT07155473
NCT06661655
Data Source & Attribution
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