ObesityBESmartNCT06061406
BE Smart - Bariatric Patient - Empowerment in the Preparation and Follow-up of Bariatric Surgery Using the Smartvisit App (BESmart)
A study testing smart visit app in people with Obesity and Bariatric Surgery Candidate, run by Wuerzburg University Hospital at 1 site in Germany.
Trial summary
Obesity affects an increasing proportion of the population and is associated with numerous comorbidities that cause increased morbidity and mortality. The most effective therapy for morbid obesity is metabolic bariatric surgery. Surgical numbers are increasing worldwide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Bariatric Surgery Candidate
- What is being tested?
- smart visit app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 2 May 2021to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- current pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Obesity affects an increasing proportion of the population and is associated with numerous comorbidities that cause increased morbidity and mortality.
The most effective therapy for morbid obesity is metabolic bariatric surgery. Surgical numbers are increasing worldwide. Before surgery, patients must try to reduce weight conservatively in a multimodal therapy concept. In addition, numerous protocols must be collected and appointments must be organized. Postoperatively, patients are expected to receive lifelong follow-up care, which increasingly overwhelms bariatric centers.
Read more
People with overweight and obesity ° I are often left largely alone with the treatment of their disease. There is a considerable gap in care here.
For the care of patients with obesity and empowerment in dealing with their disease, the smart visit app from the company aycan, which is adapted to obesity patients, is to be investigated. This is designed as a pilot project with the primary endpoint of usage and satisfaction (after 3 months, key secondary endpoint after 12 months). A total of 100 patients from 3 groups (postoperative, preoperative, permanent conservative with only overweight/obesity °I) will use the app for 1 year for this purpose.
Read the detailed description
The prevalence of obesity has been increasing dramatically for decades. The comorbidities are manifold, and the treatment of obesity is a long-term, usually lifelong task. Metabolic-bariatric surgery offers the best results. However, even after bariatric-metabolic surgery, there is a need for lifelong follow-up to ensure the success of therapy and to identify and treat possible complications, nutritional problems or deficiencies in a timely manner.
The treating centers are increasingly overwhelmed by the follow-up care of the numerous patients. At the same time, the guidelines of the professional societies recommend involving the patient in the success of his or her therapy and enabling him or her to play an active role in shaping his or her treatment. An app tailored to the treatment of obese people, which helps both in the self-organization of the patients in complying with the therapy recommendations and in maintaining contact with the center on a permanent basis and making low-threshold contact when necessary, would be a valuable addition to the existing therapy options for patients and centers alike.
Such an app would also have its value in the preoperative patient, especially since a lot of documentation work has to be done by the patient in this phase.
Patients whose obesity is not pronounced enough for a surgical procedure often complete nutritional counseling and exercise at their own expense without receiving support from experts. Here, too, there would be a need to supplement the therapy options with an appropriately coordinated app.
For the care of patients with obesity and empowerment in dealing with their disease, the smart visit app from the company aycan, which is adapted to obesity patients, is to be investigated. This is designed as a pilot project with the primary endpoint of usage and satisfaction (after 3 months, key secondary endpoint after 12 months). A total of 100 patients from 3 groups (postoperative, preoperative, permanent conservative with only overweight/obesity °I) will use the app for 1 year for this purpose.
- Conditions
- Obesity, Bariatric Surgery Candidate
- Being tested
- smart visit app
- Keywords
- App, Empowerment, Obesity, bariatric surgery
- Medical subject headings
- Obesity, Alzheimer Disease, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smart visit appDevice
Patients use an obesity-adapted version of aycan's Smartvisit app, which helps track specific behaviors (diet, exercise), query potential problems/complaints, and manage medical documents in a structured way.
A study nurse experienced in the field of nutrition/obesity contacts the patient if necessary and establishes contact with the center physician.
| Study group | Role | What they receive |
|---|---|---|
| group1 | Experimental | Bariatric-metabolic surgery (Gastric sleeve, Roux-Y gastric bypass, omega-loop bypass) at least 24 months ago, 25-45 patients in this group (total sum of patients in all three groups: 100). Receives: Device: smart visit app |
| group 2 | Experimental | Patients participating in a full or partial (if primary indication) multimodal approach prior to bariatric surgery, 25-45 patients in this group (total sum of patients in all three groups: 100). Receives: Device: smart visit app |
| group 3 | Experimental | Conservative therapy: patients with overweight/obesity grade 1 (BMI 28-34.9 kg/m2), 25-45 patients in this group (total sum of patients in all three groups: 100). Receives: Device: smart visit app |
What is being measured
The primary outcome is the main question the study is designed to answer.
satisfaction with and use of smart visit app designed for obesity them self-manage their condition. Analysis of all 3 groups cumulated. Coprimary endpoint
acceptance: questionnaire assessing the satisfaction with the app (scale 0-100, 0 meaning least possible satisfaction, 100 meaning best possible satisfaction) use: precentage of entered values in the app of the intended values (scale 0-100, 0 meaning no entered values, 100 meaning all intented values were entered)
Measured: at 3 months
Secondary outcomes (20)
satisfaction with and use of smart visit app designed for obesity them self-manage their condition. Analysis of all 3 groups cumulated. Coprimary endpoint.
acceptance: questionnaire assessing the satisfaction with the app (scale 0-100, 0 meaning least possible satisfaction, 100 meaning best possible satisfaction) use: precentage of entered values in the app of the intended values (scale 0-100, 0 meaning no entered values, 100 meaning all intented values were entered)
Measured: at 12 months
change in weight
change in weight in kilograms
Measured: at 3 months and 12 months
change in quality of life by SF-36
measured by SF-36 (short form-36) questionnaire, z-transformed scale, 0 meaning worst possible quality of life, 100 meaning best possible quality of life
Measured: at 3 months and 12 months
change in obesity related quality of life by BQL
measured by BQL (bariatric quality of life) questionnaire index, 0 meaning worst possible quality of life, 100 meaning best possible quality of life
Measured: at 3 months and 12 months
change in quality of life by EQ-5D-5L
measured by EQ-5D-5L questionnaire (European Quality of Life 5 Dimensions 5 Level Version)
Measured: at 3 months and 12 months
Depressive symptoms
measured by PHQ-9 questionnaire (Public Health Questionnaire-9), 0 meaning least possible depressive symptoms, 27 meaning worst possible depressive symptoms
Measured: at 3 months and 12 months
Eating behavior
measured by EDE-Q8 (Eating Disorder Examination Questionnaire Short Version)
Measured: at 3 months and 12 months
Number of contacts patient - center via app
Number of contacts between patients and center via app
Measured: at 3 months and 12 months
daily step counts
change in daily step counts as measured with a pedometer
Measured: at 3 months and 12 months
daily protein intake
change in daily protein intake (entered into the app) in grams
Measured: at 3 months and 12 months
daily calory intake
change in daily calory intake (entered into the app) in kcal
Measured: at 3 months and 12 months
walking distance in 6 minute walk test
change in walking distance in the 6 minute walk test in meters
Measured: at 3 months and 12 months
body composition: body fat measured by bioelectrical impedance analysis
change in body fat (in %)
Measured: at 3 months and 12 months
body composition: phase angle measured by by bioelectrical impedance analysis
change in phase angle (in °)
Measured: at 3 months and 12 months
vitamin B 12 deficiency (only group 1)
vitamin B12 levels below the lower limit of normal
Measured: at 3 months and 12 months
folic acid deficiency (only group 1)
folic acid levels below the lower limit of normal, ferritin, hemoglobin, prealbumin, 25-OH vitamin D, zinc (only group 1)
Measured: at 3 months and 12 months
iron deficiency (only group 1)
ferritin below the lower limit of normal
Measured: at 3 months and 12 months
protein malnutrition (only group 1)
prealbumin below the lower limit of normal
Measured: at 3 months and 12 months
vitamin D deficiency (only group 1)
25-OH vitamin D below the lower limit of normal
Measured: at 3 months and 12 months
zinc deficiency (only group 1)
zinc below the lower limit of normal
Measured: at 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start2 May 2021
- Primary completion31 Oct 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- aycan Medical Systems LTD, Innere Aumuehlstr. 5, 97076 Wuerzburg , Germany
- Responsible party
- Principal investigator, Ann-Cathrin Koschker, Wuerzburg University Hospital
- Investigators
- Ann-Cathrin D Koschker, Principal investigator, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061406
- Sponsor's protocol ID
- BESmart 228/20
- Acronym
- BESmart
- Status last verified
- Apr 2024
- First submitted
- 31 Mar 2022
- Last updated
- 26 Aug 2026
- 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 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BE Smart - Bariatric Patient - Empowerment in the Preparation and Follow-up of Bariatric Surgery Using the Smartvisit App (BESmart)
- ClinicalTrials.gov ID
- NCT06061406
- Acronym / sponsor ID
- BESmart / BESmart 228/20
- Conditions
- Obesity, Bariatric Surgery Candidate
- Keywords
- App, Empowerment, Obesity, bariatric surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Collaborators
- aycan Medical Systems LTD, Innere Aumuehlstr. 5, 97076 Wuerzburg , Germany
- Study start
- 2 May 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 29 Sep 2023 (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.
Obesity affects an increasing proportion of the population and is associated with numerous comorbidities that cause increased morbidity and mortality.
The most effective therapy for morbid obesity is metabolic bariatric surgery. Surgical numbers are increasing worldwide. Before surgery, patients must try to reduce weight conservatively in a multimodal therapy concept. In addition, numerous protocols must be collected and appointments must be organized. Postoperatively, patients are expected to receive lifelong follow-up care, which increasingly overwhelms bariatric centers.
People with overweight and obesity ° I are often left largely alone with the treatment of their disease. There is a considerable gap in care here.
For the care of patients with obesity and empowerment in dealing with their disease, the smart visit app from the company aycan, which is adapted to obesity patients, is to be investigated. This is designed as a pilot project with the primary endpoint of usage and satisfaction (after 3 months, key secondary endpoint after 12 months). A total of 100 patients from 3 groups (postoperative, preoperative, permanent conservative with only overweight/obesity °I) will use the app for 1 year for this purpose.
Detailed description
The prevalence of obesity has been increasing dramatically for decades. The comorbidities are manifold, and the treatment of obesity is a long-term, usually lifelong task. Metabolic-bariatric surgery offers the best results. However, even after bariatric-metabolic surgery, there is a need for lifelong follow-up to ensure the success of therapy and to identify and treat possible complications, nutritional problems or deficiencies in a timely manner.
The treating centers are increasingly overwhelmed by the follow-up care of the numerous patients. At the same time, the guidelines of the professional societies recommend involving the patient in the success of his or her therapy and enabling him or her to play an active role in shaping his or her treatment. An app tailored to the treatment of obese people, which helps both in the self-organization of the patients in complying with the therapy recommendations and in maintaining contact with the center on a permanent basis and making low-threshold contact when necessary, would be a valuable addition to the existing therapy options for patients and centers alike.
Such an app would also have its value in the preoperative patient, especially since a lot of documentation work has to be done by the patient in this phase.
Patients whose obesity is not pronounced enough for a surgical procedure often complete nutritional counseling and exercise at their own expense without receiving support from experts. Here, too, there would be a need to supplement the therapy options with an appropriately coordinated app.
For the care of patients with obesity and empowerment in dealing with their disease, the smart visit app from the company aycan, which is adapted to obesity patients, is to be investigated. This is designed as a pilot project with the primary endpoint of usage and satisfaction (after 3 months, key secondary endpoint after 12 months). A total of 100 patients from 3 groups (postoperative, preoperative, permanent conservative with only overweight/obesity °I) will use the app for 1 year for this purpose.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group1 | Experimental | Device: smart visit appBariatric-metabolic surgery (Gastric sleeve, Roux-Y gastric bypass, omega-loop bypass) at least 24 months ago, 25-45 patients in this group (total sum of patients in all three groups: 100). |
| group 2 | Experimental | Device: smart visit appPatients participating in a full or partial (if primary indication) multimodal approach prior to bariatric surgery, 25-45 patients in this group (total sum of patients in all three groups: 100). |
| group 3 | Experimental | Device: smart visit appConservative therapy: patients with overweight/obesity grade 1 (BMI 28-34.9 kg/m2), 25-45 patients in this group (total sum of patients in all three groups: 100). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- current pregnancy
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 |
|---|---|---|
| smart visit appPatients use an obesity-adapted version of aycan's Smartvisit app, which helps track specific behaviors (diet, exercise), query potential problems/complaints, and manage medical documents in a structured way. A study nurse experienced in the field of nutrition/obesity contacts the patient if necessary and establishes contact with the center physician. | Device | group 2, group 3, group1 |
Primary outcome
satisfaction with and use of smart visit app designed for obesity them self-manage their condition. Analysis of all 3 groups cumulated. Coprimary endpoint
Time frame: at 3 months
acceptance: questionnaire assessing the satisfaction with the app (scale 0-100, 0 meaning least possible satisfaction, 100 meaning best possible satisfaction) use: precentage of entered values in the app of the intended values (scale 0-100, 0 meaning no entered values, 100 meaning all intented values were entered)
20 secondary outcomes
satisfaction with and use of smart visit app designed for obesity them self-manage their condition. Analysis of all 3 groups cumulated. Coprimary endpoint.
Time frame: at 12 months
change in weight
Time frame: at 3 months and 12 months
change in quality of life by SF-36
Time frame: at 3 months and 12 months
change in obesity related quality of life by BQL
Time frame: at 3 months and 12 months
change in quality of life by EQ-5D-5L
Time frame: at 3 months and 12 months
Depressive symptoms
Time frame: at 3 months and 12 months
Eating behavior
Time frame: at 3 months and 12 months
Number of contacts patient - center via app
Time frame: at 3 months and 12 months
daily step counts
Time frame: at 3 months and 12 months
daily protein intake
Time frame: at 3 months and 12 months
daily calory intake
Time frame: at 3 months and 12 months
walking distance in 6 minute walk test
Time frame: at 3 months and 12 months
body composition: body fat measured by bioelectrical impedance analysis
Time frame: at 3 months and 12 months
body composition: phase angle measured by by bioelectrical impedance analysis
Time frame: at 3 months and 12 months
vitamin B 12 deficiency (only group 1)
Time frame: at 3 months and 12 months
folic acid deficiency (only group 1)
Time frame: at 3 months and 12 months
iron deficiency (only group 1)
Time frame: at 3 months and 12 months
protein malnutrition (only group 1)
Time frame: at 3 months and 12 months
vitamin D deficiency (only group 1)
Time frame: at 3 months and 12 months
zinc deficiency (only group 1)
Time frame: at 3 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
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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. This study is not recruiting at the moment.
Ann-Cathrin D Koschker principal investigator
Wuerzburg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smart visit app in people with Obesity and Bariatric Surgery Candidate, run by Wuerzburg University Hospital at 1 site in Germany.
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 0 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: finished, as of the sponsor's last update on 26 Aug 2026. 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 Germany. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
satisfaction with and use of smart visit app designed for obesity them self-manage their condition. Analysis of all 3 groups cumulated. Coprimary endpoint (time frame: at 3 months). 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 26 Aug 2026.