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

NCT06650943 | Recruiting

• 1 other identifier: 48.23 CEIHU
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

First Episode Psychosis (FEP); Metabolic Syndrome X

Keywords

FEP; psychosis; metabolic syndrome; nursing; mental health nurse

Outcome Measures

Primary Outcomes (1)

• Weight

  Weight in kilograms

  From enrollment to the end of treatment at 48 weeks

Secondary Outcomes (5)

• Metabolic Syndrome

  From enrollment to the end of treatment at 48 weeks

• Psychopathology

  From enrollment to the end of treatment at 48 weeks

• Depressive symptoms

  From enrollment to the end of treatment at 48 weeks

• Qualit of Life

  From enrollment to the end of treatment at 48 weeks

• Reported phisical activity

  From enrollment to the end of treatment at 48 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Nursing Consultation in Weight Management and Metabolic syndrome

Control

NO INTERVENTION

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.

Interventions

Nursing Consultation in Weight Management and Metabolic syndrome BEHAVIORAL

Based on the Carbohydrate-insulin Theory

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to the Early Intervention Program (EIP).
• First-episode psychosis (FEP) within the last 5 years.
• Diagnosis of psychosis from the F2 spectrum or an affective disorder with psychotic symptoms according to ICD-10.

You may not qualify if:

• Cognitive inability to learn or comorbid intellectual disability that interferes with study procedures.
• Comorbid diagnosis of neurological pathology.
• Language or comprehension impairments preventing accurate data collection.
• Use of hypoglycemic medication before or during the study.
• Refusal to participate

Sponsors & Collaborators

• Hospital de Basurto: lead
• Euskal Herriko Unibertsitatea. Universidad del Pais Vasco.: collaborator
• Instituto Vasco de Investigación Sanitaria (BIOEF): collaborator

Study Sites (1)

Hospital Universitario Basurto

Bilbao, Vizcaya, 48013, Spain

RECRUITING

Related Publications (1)

• Madaria L, Aymerich C, Catalan A, Gonzalez-Torres MA. Protocol of an Efficacy Study on Nursing Consultation in Weight Management and Metabolic Syndrome Based on the Carbohydrate-Insulin Theory in Individuals with First-Episode Psychosis. Nurs Rep. 2024 Dec 27;15(1):3. doi: 10.3390/nursrep15010003.

  PMID: 39852625 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Psychotic Disorders

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Lander Madaria

CONTACT

646179740; lander.madariamarijuan@osakidetza.eus

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The psychometric scale evaluators will be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mental Health Nurse Specialist

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 21, 2024
• Study Start: October 25, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)