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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое Nursing Consultation in Weight Management and Metabolic syndrome
  Based on the Carbohydrate-insulin Theory

Первичные конечные точки

• Weight [Срок оценки: From enrollment to the end of treatment at 48 weeks]

Вторичные конечные точки (5)

• Metabolic Syndrome [Срок оценки: From enrollment to the end of treatment at 48 weeks]
• Psychopathology [Срок оценки: From enrollment to the end of treatment at 48 weeks]
• Depressive symptoms [Срок оценки: From enrollment to the end of treatment at 48 weeks]
• Qualit of Life [Срок оценки: From enrollment to the end of treatment at 48 weeks]
• Reported phisical activity [Срок оценки: From enrollment to the end of treatment at 48 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Испания · 1 центр

• Hospital Universitario Basurto — Bilbao

Публикации

• 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

Идентификаторы

NCT: NCT06650943 · 48.23 CEIHU

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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