Clinical trial NCT06650943: Nursing Intervention in Weight and Metabolic Syndrome Management in First-episode Psychosis (MetaKOP)
Official title: Efficacy Study on Nursing Consultation in Weight and Metabolic Syndrome Management Based on the Carbohydrate-insulin Theory in Individuals with First-episode Psychosis (MetaKOP)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: First Episode Psychosis (FEP)
Metabolic Syndrome X
Keywords: FEP
psychosis
metabolic syndrome
nursing
mental health nurse
Lead sponsor: Hospital de Basurto
Sponsor class: OTHER
Collaborators: name: Euskal Herriko Unibertsitatea. Universidad del Pais Vasco.
name: Instituto Vasco de InvestigaciÃ³n Sanitaria (BIOEF)
First posted: 2024-10-21
Enrollment: 88
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Weight
timeFrame: From enrollment to the end of treatment at 48 weeks
Secondary outcomes:
measure: Metabolic Syndrome
timeFrame: From enrollment to the end of treatment at 48 weeks
measure: Psychopathology
timeFrame: From enrollment to the end of treatment at 48 weeks
measure: Depressive symptoms
timeFrame: From enrollment to the end of treatment at 48 weeks
measure: Qualit of Life
timeFrame: From enrollment to the end of treatment at 48 weeks
measure: Reported phisical activity
timeFrame: From enrollment to the end of treatment at 48 weeks
Other outcomes:
Locations:
city: Bilbao
country: Spain
facility: Hospital Universitario Basurto
state: Vizcaya
Study officials:
References: