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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Bariatric Surgery Candidate, Malnutrition

Intervention / Treatment
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* Other: Usability Questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomised cohort study with control group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention: Usability Questionnaire<br>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. | Other: Usability Questionnaire<br>* 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.<br>|
| Other: Control: Usability Questionnaire<br>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. | Other: Usability Questionnaire<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability questionnaire | 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 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bariatric surgery, lifelong follow-up, primary care, obesity, health care study