An interventional study of smart visit app in Obesity and Bariatric Surgery Candidate, sponsored by Wuerzburg University Hospital. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Wuerzburg University Hospital · Not applicable, Interventional, and Treatment
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.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 100 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Wuerzburg University Hospital is the lead sponsor of 98 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
General inclusion criteria:
Additional group specific inclusion criteria:
Group 1 (bariatric-metabolic surgery):
Group 2 (multimodal treatment):
Group 3 (conservative therapy):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Device: smart visit app
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).
Device: smart visit app
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).
Device: smart visit app
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.
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)
Time frame: at 3 months
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)
Time frame: at 12 months
change in weight
change in weight in kilograms
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: at 3 months and 12 months
Eating behavior
measured by EDE-Q8 (Eating Disorder Examination Questionnaire Short Version)
Time frame: at 3 months and 12 months
Number of contacts patient - center via app
Number of contacts between patients and center via app
Time frame: at 3 months and 12 months
daily step counts
change in daily step counts as measured with a pedometer
Time frame: at 3 months and 12 months
daily protein intake
change in daily protein intake (entered into the app) in grams
Time frame: at 3 months and 12 months
daily calory intake
change in daily calory intake (entered into the app) in kcal
Time frame: 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
Time frame: at 3 months and 12 months
body composition: body fat measured by bioelectrical impedance analysis
change in body fat (in %)
Time frame: at 3 months and 12 months
body composition: phase angle measured by by bioelectrical impedance analysis
change in phase angle (in °)
Time frame: at 3 months and 12 months
vitamin B 12 deficiency (only group 1)
vitamin B12 levels below the lower limit of normal
Time frame: 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)
Time frame: at 3 months and 12 months
iron deficiency (only group 1)
ferritin below the lower limit of normal
Time frame: at 3 months and 12 months
protein malnutrition (only group 1)
prealbumin below the lower limit of normal
Time frame: at 3 months and 12 months
vitamin D deficiency (only group 1)
25-OH vitamin D below the lower limit of normal
Time frame: at 3 months and 12 months
zinc deficiency (only group 1)
zinc below the lower limit of normal
Time frame: at 3 months and 12 months
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Wuerzburg University Hospital