Effects of an Integrated Multimodal Lifestyle Intervention for Management of Violence in Schizophrenia
9 de abril de 2022 actualizado por: Mei-Chi Hsu, I-Shou University
Effects of an Integrated Multimodal Lifestyle Intervention for Management of Violence Through Regulation of Serum Lipid Profile in Schizophrenia: A Randomized Controlled Trial
Total cholesterol levels and other lipids are associated with violence in psychiatric patients.
There is a paucity of studies on preventive interventions.
In this study, an integrated multimodal lifestyle intervention (MLifeI) for management of repetitive violence in schizophrenia is proposed.
A controlled clinical trial was carried out to evaluate the effects of MLifeI on management of repetitive violence through regulation of serum lipids, TC in particular, to the recommended levels in schizophrenia.
The investigators examined whether the MLifeI could: 1. regulate or balance lipid profiles; 2. reduce violence risk; 3. improve impulsivity; and 4. improve general cognitive functioning.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Total cholesterol levels and other lipids are associated with violence in psychiatric patients.
There is a paucity of studies on preventive interventions.
In this study, an integrated multimodal lifestyle intervention (MLifeI) for management of repetitive violence in schizophrenia is proposed.
A controlled clinical trial was carried out to evaluate the effects of MLifeI on management of repetitive violence through regulation of serum lipids, TC in particular, to the recommended levels in schizophrenia.
The investigators examined whether the MLifeI could: 1. regulate or balance lipid profiles; 2. reduce violence risk; 3. improve impulsivity; and 4. improve general cognitive functioning.
The multimodal lifestyle intervention included psychoeducation, lifestyle modification and health promotion and exercise.
Outcome measures comprised lipid profiles, body mass index and violence-related parameters.
Tipo de estudio
Intervencionista
Inscripción (Actual)
62
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
-
Kaohsiung City, Taiwán
- I-Shou University
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
20 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Clinical diagnosis of schizophrenia for more than 2 years
- Psychiatrically hospitalized
- Repetitive violence within one year
- Ambulatory
- Having basic literacy
- More than 20 years old
- Less than 65 years old
Exclusion Criteria:
- Clinical psychiatric diagnosis other than schizophrenia
- Physical co-morbidity or life-threatening illnesses that may impact on lipid homeostasis
- dietary restrictions for physical condition
- pregnancy
- reported disabilities
- impairments or health illness/problems that significantly limited their ability to perform the intervention such as severe arthritis, uncorrected visual or hearing impairments, developmental disability, or signs of intellectual disability.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervention Group: an integrated multimodal lifestyle intervention (MLifeI)
The MLifeI program focused on the roles of health responsibility, review of lipid profile, complications of imbalanced lipid profile, lipid management and nutritional education.
|
The MLifeI program focused on the roles of health responsibility, review of lipid profile, complications of imbalanced lipid profile, lipid management and nutritional education.
|
|
Sin intervención: Control group
The control group is the Treatment as Usual (TAU).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Weight in kilograms
Periodo de tiempo: Change of weight from baseline and 6 months (3-month follow-up)
|
Clinical Assessment: weight.
|
Change of weight from baseline and 6 months (3-month follow-up)
|
|
Height in meters
Periodo de tiempo: Change of weight from baseline and 6 months (3-month follow-up)
|
Clinical Assessment: height.
|
Change of weight from baseline and 6 months (3-month follow-up)
|
|
Body Mass Index (BMI)
Periodo de tiempo: Change of weight from baseline and 6 months (3-month follow-up)
|
Clinical Assessment: Body Mass Index; Weight and height will be combined to report BMI in kg/m^2.
The World Health Organisation defines an adult who has a BMI between 25 and 29.9 as overweight - an adult who has a BMI of 30 or higher is considered obese - a BMI below 18.5 is considered underweight, and between 18.5 to 24.9 a healthy weight.
|
Change of weight from baseline and 6 months (3-month follow-up)
|
|
Routine test in the ward of total cholesterol, triglyceride, low-density lipoprotein and high-density lipoprotein (Change is being assessed, mg/dL)
Periodo de tiempo: Change of violence risk from baseline (T1) and 6 months (T3, 3-month follow-up)
|
Lipid profiles.
Assessment of serum metabolites.
|
Change of violence risk from baseline (T1) and 6 months (T3, 3-month follow-up)
|
|
Violence Risk Screening (Change is being assessed)
Periodo de tiempo: Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
|
Questionnaires of violence.
A higher score indicates a higher violence risk.
|
Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
|
|
Attribution Questionnaire (Change is being assessed)
Periodo de tiempo: Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
|
Questionnaires of violence attributions.
The Attribution Questionnair was applied to measure the participant's internal/external attributions about the causality and likelihood of violence and responsibility for changing the behavior.
The measure was rated on a continuum scale from 1 (e.g., not at all likely; not at all able, etc.) to 7 (e.g., totally due to me; totally likely; totally able, etc.).
|
Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
|
|
Modified Overt Aggression Scale (Change is being assessed)
Periodo de tiempo: Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
|
Questionnaires of aggression frequency.
|
Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
|
|
Buss-Perry Aggression Questionnaire (Change is being assessed)
Periodo de tiempo: Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
|
Questionnaires of violence/aggression.
The higher the score is, the higher the participant has the violent behavior.
|
Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
|
|
Barratt Impulsiveness Scale (Change is being assessed)
Periodo de tiempo: Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
|
Questionnaires of impulsivity.
The score ranged from 1 (rarely/never) to 4 (almost always/always).
The higher the scores indicates the greater the impulsivity.
|
Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
|
|
Mini-Mental State Examination (Change is being assessed)
Periodo de tiempo: Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
|
Questionnaires of cognitive functioning.
The MMSE ranged from 0 to 30, where higher scores indicate better cognitive functioning.
|
Change of violence risk from baseline (T1), 3 months (T2, end of treatment), and 6 months (T3, 3-month follow-up)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
15 de agosto de 2016
Finalización primaria (Actual)
14 de agosto de 2018
Finalización del estudio (Actual)
14 de agosto de 2018
Fechas de registro del estudio
Enviado por primera vez
6 de enero de 2022
Primero enviado que cumplió con los criterios de control de calidad
27 de enero de 2022
Publicado por primera vez (Actual)
8 de febrero de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de abril de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
9 de abril de 2022
Última verificación
1 de abril de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IShouU-cholesterol I
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .