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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06650943

Acronym

MetaKOP

Enrollment

Registered

2024-10-21

Start date

2023-10-25

Completion date

2026-06-30

Last updated

2024-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First Episode Psychosis (FEP), Metabolic Syndrome X

Keywords

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

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.

Interventions

BEHAVIORALNursing Consultation in Weight Management and Metabolic syndrome

Based on the Carbohydrate-insulin Theory

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Masking description

The psychometric scale evaluators will be blinded.

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

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

Secondary

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

Countries

Spain

Contacts

Primary ContactLander Madaria

lander.madariamarijuan@osakidetza.eus646179740

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026