- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01675687
Web Based Follow up Intervention in Obesity Treatment for Women
Effects on Self-efficacy, Sustainability and Drop Out Rate Using Web Based Follow up Intervention in Obesity Treatment for Women
This study is designed to verify that web based follow up intervention after a classic multidisciplinary face-to-face obesity treatment will reinforced nutrition and exercise self-efficacy, improve drop out rate and advance sustainability after weight loss of obese women.
Research Questions and Hypotheses
- How does a web based follow up intervention change self-efficacy of women participating in an obesity intervention?
- How does a web based follow up intervention affect the drop out rate of women participating in an obesity intervention?
- How does a web based follow up intervention influence sustainability of women participating in an obesity intervention?
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Vienna, Austria, 1100
- FEM Süd
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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:
- Women
- Age 18-80
- BMI 30-40
- Internet access
- Motivation and psychological stability to stay in a long term obesity intervention
- No medical conditions prohibiting moderate physical exercise
Exclusion Criteria:
- Men
- Age under 18 years
- BMI under 30 and above 40
- No Internet access
- No motivation and psychological stability to stay in a long term obesity intervention
- Medical conditions prohibiting moderate physical exercise
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Internet
Participants of this intervention group get follow up support via Internet. They have access to new inputs biweekly consisting of
News and updates (e.g. recipes, gymnastic classes, meetings of self support groups and more) will be available each month. Tailored feedback of their behaviour will be given by documentation on spreadsheets. |
inputs will be based on elements derived from cognitive behavioural therapy, acceptance and commitment therapy, mindfulness and awareness training
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Experimental: Printed Manual
Participants of this intervention group get follow up support via a printed manual. The manual consist of all the same inputs as are available to the Internet follow up group.
All inputs will be given at once at the beginning of the follow up intervention, only news and updates (e.g. recipes, gymnastic classes, meetings of self support groups and more) will be sent per mail each month. There is no tailored feedback of their behaviour as the paper-pencil documentation on spreadsheets can't be monitored by the psychologists. |
inputs will be based on elements derived from cognitive behavioural therapy, acceptance and commitment therapy, mindfulness and awareness training
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Changes in nutrition- and exercise self-efficacy
Periodo de tiempo: Primary outcome measure is assessed at the beginning of the follow up support (baseline) and after 6 months (at completion of the follow up intervention by Internet or printed manual)
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Changes in nutrition- and exercise self-efficacy will be measured by scores in questionnaires for nutrition- and exercise self-efficacy (Sportbezogene Selbstwirksamkeitserwartung - Fuchs & Schwarzer, 1994 and Weight Efficacy Life-Style Questionnaire - Clark et al. 1991).
A change of more than one standard deviation will be considered significant.
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Primary outcome measure is assessed at the beginning of the follow up support (baseline) and after 6 months (at completion of the follow up intervention by Internet or printed manual)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Dropout rate
Periodo de tiempo: Secondary outcome measure is assessed at the beginning of the follow up support (baseline) and after 6 months (at completion of the follow up intervention by Internet or printed manual)
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The Dropout rate will be compared by the number of women available for the last meeting at the end of the follw up intervention.
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Secondary outcome measure is assessed at the beginning of the follow up support (baseline) and after 6 months (at completion of the follow up intervention by Internet or printed manual)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Sustainability of weight loss
Periodo de tiempo: Further outcome measure is assessed at the beginning of the follow up support (baseline) and after 6 months (at completion of the follow up intervention by Internet or printed manual)
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Sustainability will be measured in
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Further outcome measure is assessed at the beginning of the follow up support (baseline) and after 6 months (at completion of the follow up intervention by Internet or printed manual)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sonja Rader, Mag.a, FEM Süd
Publicaciones y enlaces útiles
Enlaces Útiles
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- EK-12-098-VK ID by EC Vienna
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. .
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