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

Efficacy Study on Nursing Consultation in Weight and Metabolic Syndrome Management Based on the Carbohydrate-insulin Theory in Individuals with First-episode Psychosis (MetaKOP)

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.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Syndrome X; First Episode Psychosis (FEP)
• Intervention / Treatment: Behavioral: Nursing Consultation in Weight Management and Metabolic syndrome

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lander Madaria; Phone Number: 646179740; Email: lander.madariamarijuan@osakidetza.eus

Study Locations

• Spain
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013
      • Recruiting
      • Hospital Universitario Basurto
      • Contact: Lander Madaria; Phone Number: 646179740; Email: landermadaria@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; Based on the Carbohydrate-insulin Theory
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Weight in kilograms	From enrollment to the end of treatment at 48 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital de Basurto
• Collaborators: Euskal Herriko Unibertsitatea. Universidad del Pais Vasco.; Instituto Vasco de Investigación Sanitaria (BIOEF)

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: October 18, 2024
• First Submitted That Met QC Criteria: October 18, 2024
• First Posted (Actual): October 21, 2024

Study Record Updates

• Last Update Posted (Actual): October 22, 2024
• Last Update Submitted That Met QC Criteria: October 20, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: psychosis; nursing; metabolic syndrome; FEP; mental health nurse
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Pathologic Processes; Metabolic Diseases; Disease; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Psychotic Disorders; Syndrome; Metabolic Syndrome; Mental Disorders
• Other Study ID Numbers: 48.23 CEIHU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No