A Prospective Randomnised Controlled Trial Comparing Overall Patient Compliance in a Bariatric Surgical Pathway Using the Standard Versus a More Intensified and Interactive Version of the "Get Ready" Smartphone Application.

December 16, 2025 updated by: Sint Dimpna Ziekenhuis Geel

The aim of this study is to assess the impact of a newly intensified digital platform following bariatric surgery. This will be measured using several questionnaires. The following objectives will be evaluated: the exact amount of weight loss achieved preoperatively with the preparatory diet; the occurrence of dumping symptoms; the assessment of quality of life (QOL); and compliance with supplement intake.

By examining the impact of an enhanced digital platform, we aim to address critical questions regarding the effectiveness of improved patient support in the digital domain. Moreover, given the increasing prevalence of bariatric surgery as a therapeutic option for obesity, it is of utmost importance to identify strategies to optimize patient education and support through digital tools. This study not only contributes to the scientific understanding of digital support in bariatric care but also has important implications for the further development of the "Get Ready" application, ensuring that it remains at the forefront of providing comprehensive and patient-centered support in the evolving landscape of bariatric surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients undergoing bariatric surgery

Exclusion Criteria:

  • Previous bariatric surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Standard GetReady application group
Other: GetReady application
Postoperative application usage
Active Comparator: Intensified GetReady application
Other: Intensified GetReady application
Postoperative application usage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: 3monts, 6 months, 12 months
Overall weight, in kg's
3monts, 6 months, 12 months
Rand-36 Health Survey
Time Frame: 12months
Health survey, score 0-100 with higher score indicating better health.
12months
Bloodwork
Time Frame: 6 months and 12 months
Deficiencys in blood results
6 months and 12 months
Sigstad score
Time Frame: 3months, 6 months and 122 months
classifying dumping symptoms, score >7 sugests dumping, score <-4 suggests other disease.
3months, 6 months and 122 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
N° of unplanned clinical visits
Time Frame: 12months
N° of unplanned clinical visits
12months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sint Dimpna Ziekenhuis Geel

Collaborators

Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2025

Primary Completion (Estimated)

January 30, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

September 23, 2025

First Submitted That Met QC Criteria

December 16, 2025

First Posted (Actual)

December 22, 2025

Study Record Updates

Last Update Posted (Actual)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 16, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERP-2023-13530

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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