- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01336946
HEalth Promotion Intervention in MEntal Health Care (HEPIMEC)
Effectiveness and Cost-effectiveness of a Health Promotion Intervention Targeting Physical Activity and Eating Habits in Persons With Mental Disorders
Overweight and obesity have become a serious global public health problem and the prevalence of these conditions is even higher among persons with mental disorders, compared with the general population. Overweight and obesity are partially associated with sedentary lifestyles and unhealthy eating habits.
The aim of the study is to examine the effectiveness and cost-effectiveness of a health promotion intervention targeting physical activity and eating habits in persons with mental disorders.
The study hypothesis is that between baseline and the end of the intervention, and after a 6-month follow up period, significant differences in the primary and secondary outcomes between the intervention and control group will be identified. The investigators also hypothesize that the health promotion intervention will be cost-effective.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Antwerpen, Bélgica
- Beschut Wonen Antwerpen
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Antwerpen, Bélgica
- Beschut Wonen Min
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Beernem, Bélgica
- Beschut Wonen Beernem
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Beigem, Bélgica
- Beschut Wonen De Raster
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Blankenberge, Bélgica
- Beschut Wonen Oostkust
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Brugge, Bélgica
- Beschut Wonen Brugge
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Diest, Bélgica
- Beschut Wonen De Linde
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Eeklo, Bélgica
- Beschut Wonen De Wende
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Gent, Bélgica
- Beschut Wonen Centrum Onderweg
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Gent, Bélgica
- Beschut Wonen Delta Wonen
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Gent, Bélgica
- Beschut Wonen Domos
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Gent, Bélgica
- Beschut Wonen Zagan
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Hasselt, Bélgica
- Beschut Wonen Basis
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Heusden-Zolder, Bélgica
- Beschut Wonen West-Limburg
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Izegem, Bélgica
- Beschut Wonen regio Izegem
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Kortrijk, Bélgica
- Beschut Wonen De Bolster
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Leuven, Bélgica
- Beschut Wonen De Hulster
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Maasmechelen, Bélgica
- Beschut Wonen Het Veer
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Menen, Bélgica
- Beschut Wonen Eigen Woonst
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Oostende, Bélgica
- Beschut Wonen Oostende
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Overpelt, Bélgica
- Beschut Wonen Noord-Limburg
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Roeselare, Bélgica
- Beschut Wonen Roeselare-Tielt
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Sint-Niklaas, Bélgica
- Beschut Wonen Pro Mente
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Sint-Niklaas, Bélgica
- Beschut Wonen Waasland
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Veurne, Bélgica
- Beschut Wonen Veurne-Diksmuide
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 18 years of age or older
- living in sheltered housing
- diagnosed according to the Diagnostic and Statistical Manual of mental disorders (DSM-IV manual)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: health promotion program
Psycho education and behavioural group sessions and supervised walking sessions will be performed.
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10 psycho educational and behavioural group sessions on topics like the Food Triangle, healthy eating, the importance of physical activity, healthy eating on a limited budget, implementing physical activity into the daily life, the influence of advertisements...
A weekly supervised walking session (30 minutes) in a 10-week period.
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Sin intervención: Control group
No intervention will be performed in this control group.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
change in body weight 10 weeks post-intervention
Periodo de tiempo: after 10 weeks
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The primary outcome of the study consists of changes in body weight between baseline and 10-weeks post-intervention in the intervention and control group separately and between the intervention and the control group.The participants will be weighed in light clothing without shoes, with standardised measurement.
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after 10 weeks
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change in body weight 26 weeks post-intervention
Periodo de tiempo: after 26 weeks
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The primary outcome of the study consists of changes in body weight between baseline and 26-weeks post-intervention in the intervention and control group separately and between the intervention and the control group.The participants will be weighed in light clothing without shoes, with standardised measurement.
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after 26 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Body Mass Index 10 weeks post-intervention
Periodo de tiempo: after 10 weeks
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Body Mass Index, calculated as the weight in kilograms divided by the square of the height in metres (kg/m²)
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after 10 weeks
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Body Mass Index, 26 weeks post-intervention
Periodo de tiempo: after 26 weeks
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Body Mass Index, calculated as the weight in kilograms divided by the square of the height in metres (kg/m²).
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after 26 weeks
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Waist circumference, 10 weeks post-intervention
Periodo de tiempo: After 10 weeks
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Waist circumference, assessed by using a tape measure.
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After 10 weeks
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Waist circumference, 26 weeks post-intervention
Periodo de tiempo: After 26 weeks
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Waist circumference, assessed by using a tape measure.
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After 26 weeks
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Quality of Life, 10 weeks post-intervention
Periodo de tiempo: After 10 weeks
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Quality of life, assessed by using the SF-36 Health Survey.
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After 10 weeks
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Quality of Life, 26 weeks post-intervention
Periodo de tiempo: After 26 weeks
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Quality of life, assessed by using the SF-36 Health Survey.
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After 26 weeks
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Levels of physical activity, 10 weeks post-intervention
Periodo de tiempo: After 10 weeks
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Levels of physical activity, assessed by using the International Physical Activity Questionnaire long version (IPAQ) and by using pedometers.
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After 10 weeks
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Levels of physical activity, 26 weeks post-intervention
Periodo de tiempo: After 26 weeks
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Levels of physical activity, assessed by using the International Physical Activity Questionnaire long version (IPAQ) and by using pedometers.
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After 26 weeks
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Eating habits, 10 weeks post-intervention
Periodo de tiempo: After 10 weeks
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Eating habits, assessed by using a 24-hour dietary recall.
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After 10 weeks
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Eating habits, 26 weeks post-intervention
Periodo de tiempo: After 26 weeks
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Eating habits, assessed by using a 24-hour dietary recall.
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After 26 weeks
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Psychiatric symptom severity, 10 weeks post-intervention
Periodo de tiempo: After 10 weeks
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Psychiatric symptom severity, assessed by using the Brief Symptom Inventory (BSI).
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After 10 weeks
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Psychiatric symptom severity, 26 weeks post-intervention
Periodo de tiempo: After 26 weeks
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Psychiatric symptom severity, assessed by using the Brief Symptom Inventory (BSI).
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After 26 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lieven Annemans, Ph.D., Professor, University Ghent
Publicaciones y enlaces útiles
Publicaciones Generales
- Verhaeghe N, Clays E, Vereecken C, De Maeseneer J, Maes L, Van Heeringen C, De Bacquer D, Annemans L. Health promotion in individuals with mental disorders: a cluster preference randomized controlled trial. BMC Public Health. 2013 Jul 15;13:657. doi: 10.1186/1471-2458-13-657.
- Verhaeghe N, De Maeseneer J, Maes L, Van Heeringen C, Bogaert V, Clays E, De Bacquer D, Annemans L. Health promotion intervention in mental health care: design and baseline findings of a cluster preference randomized controlled trial. BMC Public Health. 2012 Jun 13;12:431. doi: 10.1186/1471-2458-12-431.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- EC/2010/607
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