Efficacy Study on Nursing Consultation in Weight and Metabolic Syndrome Management Based on the Carbohydrate-insulin Theory in Individuals with First-episode Psychosis (MetaKOP)
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
- 否
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
Lander Madaria Marijuan
Mental Health Nurse Specialist
Hospital de Basurto