Image

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

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

Recruiting
All
Phase N/A

Powered by AI

Overview

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

Inclusion Criteria:

  1. Patients admitted to the Early Intervention Program (EIP).
  2. First-episode psychosis (FEP) within the last 5 years.
  3. Diagnosis of psychosis from the F2 spectrum or an affective disorder with psychotic symptoms according to ICD-10.

Exclusion Criteria:

  1. Cognitive inability to learn or comorbid intellectual disability that interferes with study procedures.
  2. Comorbid diagnosis of neurological pathology.
  3. Language or comprehension impairments preventing accurate data collection.
  4. Use of hypoglycemic medication before or during the study.
  5. Refusal to participate

Study details
    First Episode Psychosis (FEP)
    Metabolic Syndrome X

NCT06650943

Hospital de Basurto

15 September 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.