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

Malnutrition Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03792412
• Other study ID #: 2079/2017
• Status: Recruiting
• Phase: N/A
• Start date: May 22, 2018
• Est. completion date: January 2020

Study information

• Verified date: January 2019
• Source: Medical University of Vienna
• Contact: Tamara Ranzenberger-Haider, MSc
• Phone: 00436765202648
• Email: tamara.ranzenberger-haider[@]muv.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: January 2020
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Malnutrition

Intervention

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.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

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