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

Not Applicable

Recruiting

• Conditions: First Episode Psychosis (FEP); Metabolic Syndrome X

• Registration Number: NCT06650943
• Lead Sponsor: Hospital de Basurto

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-25
• Status Verified: 2024-10
• Study First Submitted: 2024-10-18
• Study First Submitted QC: 2024-10-18
• Last Update Submitted: 2024-10-20
• Study First Posted: 2024-10-21
• Last Update Posted: 2024-10-22
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Weight	From enrollment to the end of treatment at 48 weeks	Weight in kilograms

Secondary Outcome Measures

Name	Time	Method
Metabolic Syndrome	From enrollment to the end of treatment at 48 weeks	According to the International Diabetes Federation (IDF)
Psychopathology	From enrollment to the end of treatment at 48 weeks	measured using PANSS scale
Depressive symptoms	From enrollment to the end of treatment at 48 weeks	measured by Hamilton Depression Rating Scale
Qualit of Life	From enrollment to the end of treatment at 48 weeks	EuroQoL 5D scale will be used
Reported phisical activity	From enrollment to the end of treatment at 48 weeks	International Physical Activity Questionnaire (IPAQ)

Trial Locations

Locations (1)

Hospital Universitario Basurto; 🇪🇸 Bilbao, Vizcaya, Spain