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

NCT06650943 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2024-10-22

No results posted yet for this study

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

BEHAVIORAL

Nursing Consultation in Weight Management and Metabolic syndrome

Based on the Carbohydrate-insulin Theory

Sponsors & Collaborators

  • Euskal Herriko Unibertsitatea. Universidad del Pais Vasco.

    collaborator UNKNOWN

  • Instituto Vasco de Investigación Sanitaria (BIOEF)

    collaborator UNKNOWN

  • Hospital de Basurto

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-25
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06650943 on ClinicalTrials.gov