An interventional study of Nursing Consultation in Weight Management and Metabolic syndrome in First Episode Psychosis (FEP) and Metabolic Syndrome X, sponsored by Hospital de Basurto. Recruiting at 1 site in Spain. Per ClinicalTrials.gov, last updated 2024-10-22.
Sponsored by Hospital de Basurto · Not applicable, Interventional, and Supportive care
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.
Exclusion Criteria:
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
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.
Based on the Carbohydrate-insulin Theory
Weight
Weight in kilograms
Time frame: From enrollment to the end of treatment at 48 weeks
Metabolic Syndrome
According to the International Diabetes Federation (IDF)
Time frame: From enrollment to the end of treatment at 48 weeks
Psychopathology
measured using PANSS scale
Time frame: From enrollment to the end of treatment at 48 weeks
Depressive symptoms
measured by Hamilton Depression Rating Scale
Time frame: From enrollment to the end of treatment at 48 weeks
Qualit of Life
EuroQoL 5D scale will be used
Time frame: From enrollment to the end of treatment at 48 weeks
Reported phisical activity
International Physical Activity Questionnaire (IPAQ)
Time frame: From enrollment to the end of treatment at 48 weeks
Plan to share: No
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