NCT06650943

Nursing Intervention in Weight and Metabolic Syndrome Management in First-episode Psychosis (MetaKOP)

Efficacy Study on Nursing Consultation in Weight and Metabolic Syndrome Management Based on the Carbohydrate-insulin Theory in Individuals with First-episode Psychosis (MetaKOP)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Hospital de Basurto · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• First Episode Psychosis (FEP)
• Metabolic Syndrome X

Interventions

Type	Name	Description
BEHAVIORAL	Nursing Consultation in Weight Management and Metabolic syndrome	Based on the Carbohydrate-insulin Theory

Timeline

• Start date: 2023-10-25
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2024-10-21
• Last updated: 2024-10-22

Locations

1 site across 1 country: Spain