Clinical trial NCT03792412: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Bariatric Surgery Candidate
Malnutrition
Keywords: bariatric surgery
lifelong follow-up
primary care
obesity
health care study
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomised cohort study with control group
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Usability questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: change in fat free mass
timeFrame: 6 months
measure: change in body weight
timeFrame: 6 months
measure: Measures of adherence after 6 months
timeFrame: 6 months
measure: Calcium Blood Value
timeFrame: 6 months
measure: Iron Blood Value
timeFrame: 6 months
measure: Vitamin B12 Blood Value
timeFrame: 6 months
measure: Vitamin D Blood Value
timeFrame: 6 months
measure: Folic Acid Blood Value
timeFrame: 6 months
measure: HbA1c Blood Value
timeFrame: 6 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
state: Please Select
Study officials:
References: