Obesity &Amp; OverweightNCT07297342
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.
A study testing GetReady application and Intensified GetReady application in people with Obesity &Amp; Overweight and Hypertension, run by Sint Dimpna Ziekenhuis Geel at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obesity &Amp; Overweight, Hypertension, Obstructive Sleep Apnea (OSAS)
- What is being tested?
- GetReady application and Intensified GetReady application
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Apr 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing bariatric surgery
Who cannot join
- Previous bariatric surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Sint Dimpna ziekenhuis
Geel
Ruben Vanlommel, Doctor, 014577777, ruben.vanlommel@ziekenhuisgeel.be
About this study
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.
- Conditions
- Obesity &Amp; Overweight, Hypertension, Obstructive Sleep Apnea (OSAS), Diabetes Mellitus ( Type 1 and Type 2)
- Being tested
- GetReady application, Intensified GetReady application
- Keywords
- Get Ready, application, bariatric, compliance
- Medical subject headings
- Obesity, Overweight, Hypertension, Sleep Apnea, Obstructive, Diabetes Mellitus, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GetReady applicationOther
Postoperative application usage
Intensified GetReady applicationOther
Postoperative application usage
| Study group | Role | What they receive |
|---|---|---|
| Standard GetReady application group | Placebo comparator | Standard GetReady application group Receives: Other: GetReady application |
| Intensified GetReady application | Active comparator | Intensified GetReady application Receives: Other: Intensified GetReady application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Overall weight, in kg's
Measured: 3monts, 6 months, 12 months
Rand-36 Health Survey
Health survey, score 0-100 with higher score indicating better health.
Measured: 12months
Bloodwork
Deficiencys in blood results
Measured: 6 months and 12 months
Sigstad score
classifying dumping symptoms, score >7 sugests dumping, score <-4 suggests other disease.
Measured: 3months, 6 months and 122 months
Secondary outcomes (1)
N° of unplanned clinical visits
N° of unplanned clinical visits
Measured: 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start2 Apr 2025
- Primary completion30 Jan 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity &Amp; OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sint Dimpna Ziekenhuis Geel
- Sponsor type
- Research network
- Collaborators
- Medtronic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297342
- Sponsor's protocol ID
- ERP-2023-13530
- Status last verified
- Dec 2025
- First submitted
- 23 Sep 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07297342
- Acronym / sponsor ID
- ERP-2023-13530
- Conditions
- Obesity &Amp; Overweight, Hypertension, Obstructive Sleep Apnea (OSAS), Diabetes Mellitus ( Type 1 and Type 2)
- Keywords
- Get Ready, application, bariatric, compliance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sint Dimpna Ziekenhuis GeelResearch network
- Collaborators
- Medtronic
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard GetReady application group | Placebo comparator | Other: GetReady applicationStandard GetReady application group |
| Intensified GetReady application | Active comparator | Other: Intensified GetReady applicationIntensified GetReady application |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing bariatric surgery
Key exclusion criteria (1 listed)
- Previous bariatric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GetReady applicationPostoperative application usage | Other | Standard GetReady application group |
| Intensified GetReady applicationPostoperative application usage | Other | Intensified GetReady application |
Primary outcome
Weight
Time frame: 3monts, 6 months, 12 months
Overall weight, in kg's
Rand-36 Health Survey
Time frame: 12months
Health survey, score 0-100 with higher score indicating better health.
Bloodwork
Time frame: 6 months and 12 months
Deficiencys in blood results
Sigstad score
Time frame: 3months, 6 months and 122 months
classifying dumping symptoms, score >7 sugests dumping, score <-4 suggests other disease.
1 secondary outcome
N° of unplanned clinical visits
Time frame: 12months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GetReady application and Intensified GetReady application in people with Obesity &Amp; Overweight and Hypertension, run by Sint Dimpna Ziekenhuis Geel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruben Vanlommel, Doctor (014577777, ruben.vanlommel@ziekenhuisgeel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: 3monts, 6 months, 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.