NCT03792412

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 3, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

January 3, 2019

Status Verified

January 1, 2019

Enrollment Period

11 months

First QC Date

December 1, 2018

Last Update Submit

January 1, 2019

Conditions

Bariatric Surgery CandidateMalnutrition

Keywords

bariatric surgerylifelong follow-upprimary careobesityhealth care study

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • change in fat free mass

    6 months

  • change in body weight

    6 months

  • Measures of adherence after 6 months

    6 months

  • Calcium Blood Value

    6 months

  • Iron Blood Value

    6 months

  • +4 more secondary outcomes

Study Arms (2)

Intervention: Usability Questionnaire

EXPERIMENTAL

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

Control: Usability Questionnaire

OTHER

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

Interventions

Usability QuestionnaireOTHER

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.

Control: Usability QuestionnaireIntervention: Usability Questionnaire

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • Pregnancy (a possible existing pregnancy is excluded by questioning)
  • Nursing mothers
  • Not German speaking patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, Please Select, 1090, Austria

RECRUITING

MeSH Terms

Conditions

MalnutritionObesity

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesOverweightOvernutritionBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Tamara Ranzenberger-Haider, MSc

CONTACT

00436765202648tamara.ranzenberger-haider@muv.ac.at

Michael Krebs, Prof.Dr.

CONTACT

+43 (0)1 40400-72570michael.krebs@muv.ac.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
pseudonymity
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomised cohort study with control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 1, 2018

First Posted

January 3, 2019

Study Start

May 22, 2018

Primary Completion

May 1, 2019

Study Completion

January 1, 2020

Last Updated

January 3, 2019

Record last verified: 2019-01

Locations

AU(1)