RecruitingNot ApplicableNCT06650943

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)


Sponsor

Hospital de Basurto

Enrollment

88 participants

Start Date

Oct 25, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is testing a structured nursing program focused on healthy eating, physical activity, and lifestyle coaching to help people in early-stage psychosis (their first episode of serious mental illness) manage weight gain and metabolic problems that can be caused by antipsychotic medications. **You may be eligible if...** - You have been admitted to an Early Intervention Program (EIP) for psychosis - Your first episode of psychosis occurred within the last 5 years - You have a diagnosis of a psychotic disorder or an affective disorder with psychotic symptoms **You may NOT be eligible if...** - You have a significant cognitive disability that prevents learning - You have a neurological diagnosis that would interfere with the study - You have language or comprehension difficulties that prevent proper data collection - You are already taking blood sugar-lowering (hypoglycemic) medication Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALNursing Consultation in Weight Management and Metabolic syndrome

Based on the Carbohydrate-insulin Theory


Locations(1)

Hospital Universitario Basurto

Bilbao, Vizcaya, Spain

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NCT06650943


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