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

Primary Purpose

Bariatric Surgery Candidate, Malnutrition

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Usability Questionnaire
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bariatric Surgery Candidate focused on measuring bariatric surgery, lifelong follow-up, primary care, obesity, health care study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention: Usability Questionnaire

Control: Usability Questionnaire

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 1, 2018
Last Updated
January 1, 2019
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT03792412
Brief Title
BagEL - Bariatric Patients in Primary Care: Post-operative Nutrition and Lifestyle Management
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 22, 2018 (Actual)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Candidate, Malnutrition
Keywords
bariatric surgery, lifelong follow-up, primary care, obesity, health care study

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomised cohort study with control group
Masking
Participant
Masking Description
pseudonymity
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention: Usability Questionnaire
Arm Type
Experimental
Arm Description
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.
Arm Title
Control: Usability Questionnaire
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Usability Questionnaire
Intervention Description
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.
Primary Outcome Measure Information:
Title
Usability questionnaire
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
change in fat free mass
Description
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.
Time Frame
6 months
Title
change in body weight
Description
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.
Time Frame
6 months
Title
Measures of adherence after 6 months
Description
Number of patients returning to the outpatient clinic after the intervention.
Time Frame
6 months
Title
Calcium Blood Value
Description
Change in Calcium levels (mg/dL) after 6 months
Time Frame
6 months
Title
Iron Blood Value
Description
Change in Ferritin levels (ng/mL) after 6 months
Time Frame
6 months
Title
Vitamin B12 Blood Value
Description
Change in B12 levels (pmol/L) after 6 months
Time Frame
6 months
Title
Vitamin D Blood Value
Description
Change in Vitamin D, 25-Hydroxy levels (nmol/L) after 6 months
Time Frame
6 months
Title
Folic Acid Blood Value
Description
Change in Folic Acid levels (nmol/L) after 6 months
Time Frame
6 months
Title
HbA1c Blood Value
Description
Change in Hemoglobin A1c (%) after 6 months
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tamara Ranzenberger-Haider, MSc
Phone
00436765202648
Email
tamara.ranzenberger-haider@muv.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Krebs, Prof.Dr.
Phone
+43 (0)1 40400-72570
Email
michael.krebs@muv.ac.at
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
State/Province
Please Select
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamara Ranzenberger-Haider, MSc
Phone
00436765202648
Email
tamara.ranzenberger-haider@muv.ac.at

12. IPD Sharing Statement

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

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