跳至主要内容
临床试验/NCT06650943
NCT06650943招募中不适用

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

Hospital de Basurto2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2023年10月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
88
试验地点
2
主要终点
Weight

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

The psychometric scale evaluators will be blinded.

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Weight

时间窗: From enrollment to the end of treatment at 48 weeks

Weight in kilograms

次要结局

  • 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)

研究者

发起方
Hospital de Basurto
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lander Madaria Marijuan

Mental Health Nurse Specialist

Hospital de Basurto

研究点 (2)

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