BagEL - Bariatric Patients in Primary Care: Post-operative Nutrition and Lifestyle Management

Not Applicable

Brief Summary: There is a growing number of patients undergoing bariatric surgery requiring lifelong follow-up. BagEL (Bariatric Patients in Primary Care: Post-operative Nutrition and Lifestyle Management) is a survey to evaluate a newly developed structured disease management program including nutrition and lifestyle management in primary care.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Intervention: Usability Questionnaire	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.
Control: Usability Questionnaire	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.

Primary Outcome Measures

Name	Time	Method
Usability questionnaire	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Calcium Blood Value	6 months	Change in Calcium levels (mg/dL) after 6 months
Vitamin B12 Blood Value	6 months	Change in B12 levels (pmol/L) after 6 months
Vitamin D Blood Value	6 months	Change in Vitamin D, 25-Hydroxy levels (nmol/L) after 6 months
Folic Acid Blood Value	6 months	Change in Folic Acid levels (nmol/L) after 6 months
HbA1c Blood Value	6 months	Change in Hemoglobin A1c (%) after 6 months
change in fat free mass	6 months	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.
change in body weight	6 months	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.
Measures of adherence after 6 months	6 months	Number of patients returning to the outpatient clinic after the intervention.
Iron Blood Value	6 months	Change in Ferritin levels (ng/mL) after 6 months

Locations (1): Medical University of Vienna
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Vienna, Please Select, Austria