BagEL - Bariatric Patients in Primary Care: Post-operative Nutrition and Lifestyle Management
BagEL - Bariatric Patients in Primary Care: Post-operative Nutrition and Lifestyle Management Evaluation of a Post-operative Nutrition and Lifestyle Management for Lifelong Care of Post-bariatric Patients in Primary Care
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
During last decades the prevalence of obesity is growing. Therefore, the number of bariatric procedures are also increasing. Frequent complications after surgery are nutritional deficiencies (e.g. vitamins, minerals, protein) which require mandatory long-term follow-up. So far adequate follow-up programs are only provided in specialized bariatric centers like in the outpatient clinic for obesity at the General Hospital of Vienna. These programs are focusing on prevention and premature identification of deficiencies.
Rising numbers of bariatric-surgical procedures pose a challenge for bariatric centres because of the accumulating numbers of bariatric patients requesting follow-up at least once a year.
To provide full coverage an appropriate possibility would be to transfer follow up to non-specialised facilities including general practitioners and family doctors using a so called "pass" providing practical treatment recommendations (necessary follow-up appointments, laboratory blood tests, questions regarding nutrition and lifestyle behavior).
To our best knowledge such a structured post-bariatric care management program in primary care does not exist by now. The aim of this study is therefore the evaluation of such a pass.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Please Select
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Vienna, Please Select, Austria, 1090
- Reclutamiento
- Medical University of Vienna
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Contacto:
- Tamara Ranzenberger-Haider, MSc
- Número de teléfono: 00436765202648
- Correo electrónico: tamara.ranzenberger-haider@muv.ac.at
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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:
- older than 18 years and each sex,
- bariatric-surgical treatment - in particular omega loop gastric bypass, Roux-en-Y-gastric bypass - and sleeve gastrectomy at the department of surgery General Hospital Vienna,
- Operation date maximum 21 months before study beginning,
Exclusion criteria:
- Pregnancy (a possible existing pregnancy is excluded by questioning)
- Nursing mothers
- Not German speaking patients
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Intervention: Usability Questionnaire
Patients hand over the usability questionnaire to evaluate the self developed structured follow-up program in form of a so-called pass to their family doctor twice in six months.
Family doctors examine the postbariatric patient using the pass and evaluate the usability by filling out the questionnaire and return the usability questionnaire to the investigator.
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Patients receive the usability questionnaire and a structured nutrition and lifestyle program for post-bariatric follow-up visits.
Twice in six months the patients visit their family doctor and hand over the usability questionnaire to evaluate the structured follow-up program for postbariatric patients.
Family doctors fill out the questionnaire and returns it to the investigator.
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Otro: Control: Usability Questionnaire
Patients hand over the usability questionnaire to evaluate the state of the art guideline for postbariatric follow up appointments in form of a folder "Metabolische Chirurgie und die perioperative Betreuung" to their family doctor twice in six months.
Family doctors examine the postbariatric patient using the guideline and evaluate the usability by filling out the questionnaire and return the usability questionnaire to the investigator.
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Patients receive the usability questionnaire and a structured nutrition and lifestyle program for post-bariatric follow-up visits.
Twice in six months the patients visit their family doctor and hand over the usability questionnaire to evaluate the structured follow-up program for postbariatric patients.
Family doctors fill out the questionnaire and returns it to the investigator.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Usability questionnaire
Periodo de tiempo: 6 months
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Usability of the follow-up passes (intervention and control) will be evaluated in primary care. In a pilot study the usability questionnaire was evaluated. The patient hands over the follow-up pass together with the questionnaire at each appointment (twice) at the family doctor. A stamped envelope to return the questionnaire is included. Family doctors will be asked to complete a series of actions regarding the content of the follow-up passes. Each action will be rated in a 5 point likert scale. An average score will be calculated for each question. |
6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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change in fat free mass
Periodo de tiempo: 6 months
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A Bioelectric impedance analysis will be used to calculate change in fat free mass.
Measurements will be conducted by a device sending weak electric signals through the patients body.
The method is non-invasive.
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6 months
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change in body weight
Periodo de tiempo: 6 months
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Patients will be asked to remove shoes, socks, heavy clothing and jewelry for measurement of body weight to the nearest 100 g using a digital scale.
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6 months
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Measures of adherence after 6 months
Periodo de tiempo: 6 months
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Number of patients returning to the outpatient clinic after the intervention.
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6 months
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Calcium Blood Value
Periodo de tiempo: 6 months
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Change in Calcium levels (mg/dL) after 6 months
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6 months
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Iron Blood Value
Periodo de tiempo: 6 months
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Change in Ferritin levels (ng/mL) after 6 months
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6 months
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Vitamin B12 Blood Value
Periodo de tiempo: 6 months
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Change in B12 levels (pmol/L) after 6 months
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6 months
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Vitamin D Blood Value
Periodo de tiempo: 6 months
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Change in Vitamin D, 25-Hydroxy levels (nmol/L) after 6 months
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6 months
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Folic Acid Blood Value
Periodo de tiempo: 6 months
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Change in Folic Acid levels (nmol/L) after 6 months
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6 months
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HbA1c Blood Value
Periodo de tiempo: 6 months
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Change in Hemoglobin A1c (%) after 6 months
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6 months
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
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
- 2079/2017
Información sobre medicamentos y dispositivos, documentos del estudio
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