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

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.

Study Overview

• Status: Unknown
• Conditions: Malnutrition; Bariatric Surgery Candidate
• Intervention / Treatment: Other: Usability Questionnaire

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.

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Please Select
    • Vienna, Please Select, Austria, 1090
      • Recruiting
      • Medical University of Vienna
      • Contact: Tamara Ranzenberger-Haider, MSc; Phone Number: 00436765202648; Email: tamara.ranzenberger-haider@muv.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Usability Questionnaire; 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.
Other: 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.	Other: Usability Questionnaire; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2018
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: December 1, 2018
• First Submitted That Met QC Criteria: January 1, 2019
• First Posted (Actual): January 3, 2019

Study Record Updates

• Last Update Posted (Actual): January 3, 2019
• Last Update Submitted That Met QC Criteria: January 1, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: obesity; bariatric surgery; primary care; lifelong follow-up; health care study
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: 2079/2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No