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

Hospital de Basurto

Status: Enrolling

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

Treatments: Behavioral: Nursing Consultation in Weight Management and Metabolic syndrome

Study type: Interventional

Funder types: Other

Identifiers

NCT06650943

48.23 CEIHU

Details and patient eligibility

About

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.

Enrollment: 88 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 2 patient groups

Intervention

Experimental group

Description:

The intervention consists of 8 nursing consultations with a mental health nurse trained in healthy habits for individuals with psychosis. During the first 2 months, 4 consultations will focus on dietary habits based on the carbohydrate-insulin theory and physical activity, following a guide developed by experts, incorporating recommendations from the American Diabetes Association. Visits 5 and 6 occur at 3 and 4 months; visit 7 at 6 months to evaluate effectiveness, and visit 8 at 12 months. Weight will be monitored throughout. Assessments at baseline, 6, and 12 months will include labs, vital signs, and scales for psychopathology, quality of life, and activity level. Each session covers key topics, from intervention goals to diet tips and physical activity. The approach is flexible, aiming for gradual habit integration, supported by a therapeutic relationship. Phone reminders will enhance adherence.

Treatment:

Behavioral: Nursing Consultation in Weight Management and Metabolic syndrome

Control

No Intervention group

Description:

Ccontrol group will continue their usual follow-up within the EIP, attending consultations with their reference psychiatrist and receiving pharmacological or psychotherapeutic treatment as they did before the intervention. The control group will not receive any specific nursing consultations (beyond the administration of long-acting injectable antipsychotics where appropriate) or dietary or lifestyle advice during the follow-up. If patients in the control group require treatment or assistance for metabolic problems, they will be referred to primary care or endocrinology professionals, as was done previous to the intervention implementation.