Nursing intervention for weight and metabolic management in first-episode psychosis
Efficacy Study on Nursing Consultation in Weight and Metabolic Syndrome Management Based on the Carbohydrate-insulin Theory in Individuals with First-episode Psychosis (MetaKOP)
This study tests if a special nursing program that focuses on diet and exercise can help people with first-episode psychosis lose weight and improve their overall health compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Sex | All |
| Sponsor | Hospital de Basurto Academic / other |
| Locations | 1 site (Bilbao, Vizcaya) |
| Trial ID | NCT06650943 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a nursing intervention based on the carbohydrate-insulin model to reduce weight and manage metabolic syndrome in individuals experiencing first-episode psychosis. Participants will receive specialized nursing consultations focused on dietary habits and physical activity over a series of 8 sessions. The study aims to determine if this intervention leads to significant weight loss and improvements in metabolic parameters, psychological state, and quality of life compared to routine care. Assessments will be conducted at the start, 6 months, and 12 months to measure outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with first-episode psychosis within the last 5 years who are admitted to the Early Intervention Program.
Not a fit: Patients with cognitive impairments, neurological pathologies, or those on hypoglycemic medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve weight management and reduce metabolic syndrome risk in patients with first-episode psychosis.
How similar studies have performed: Other studies have shown promising results with nursing interventions in managing metabolic syndrome, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bilbao, Vizcaya
- Hospital Universitario Basurto — Bilbao, Vizcaya, Spain (Recruiting)
Study contacts
- Study coordinator: Lander Madaria
- Email: lander.madariamarijuan@osakidetza.eus
- Phone: 646179740
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.