BE Smart - Bariatric Patient - Empowerment in the Preparation and Follow-up of Bariatric Surgery Using the Smartvisit App (BESmart)
- Conditions
- Bariatric Surgery CandidateObesity
- Interventions
- Device: smart visit app
- Registration Number
- NCT06061406
- Lead Sponsor
- Wuerzburg University Hospital
- Brief 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. 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
Not provided
• current pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description group1 smart visit app 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). group 2 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). group 3 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).
- Primary Outcome Measures
Name Time Method satisfaction with and use of smart visit app designed for obesity them self-manage their condition. Analysis of all 3 groups cumulated. Coprimary endpoint 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)
- Secondary Outcome Measures
Name Time Method daily calory intake at 3 months and 12 months change in daily calory intake (entered into the app) in kcal
change in weight at 3 months and 12 months change in weight in kilograms
change in quality of life by SF-36 at 3 months and 12 months 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
walking distance in 6 minute walk test at 3 months and 12 months change in walking distance in the 6 minute walk test in meters
body composition: body fat measured by bioelectrical impedance analysis at 3 months and 12 months change in body fat (in %)
satisfaction with and use of smart visit app designed for obesity them self-manage their condition. Analysis of all 3 groups cumulated. Coprimary endpoint. at 12 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)
change in obesity related quality of life by BQL at 3 months and 12 months measured by BQL (bariatric quality of life) questionnaire index, 0 meaning worst possible quality of life, 100 meaning best possible quality of life
folic acid deficiency (only group 1) at 3 months and 12 months folic acid levels below the lower limit of normal, ferritin, hemoglobin, prealbumin, 25-OH vitamin D, zinc (only group 1)
Eating behavior at 3 months and 12 months measured by EDE-Q8 (Eating Disorder Examination Questionnaire Short Version)
daily step counts at 3 months and 12 months change in daily step counts as measured with a pedometer
change in quality of life by EQ-5D-5L at 3 months and 12 months measured by EQ-5D-5L questionnaire (European Quality of Life 5 Dimensions 5 Level Version)
Depressive symptoms at 3 months and 12 months measured by PHQ-9 questionnaire (Public Health Questionnaire-9), 0 meaning least possible depressive symptoms, 27 meaning worst possible depressive symptoms
vitamin D deficiency (only group 1) at 3 months and 12 months 25-OH vitamin D below the lower limit of normal
Number of contacts patient - center via app at 3 months and 12 months Number of contacts between patients and center via app
body composition: phase angle measured by by bioelectrical impedance analysis at 3 months and 12 months change in phase angle (in °)
vitamin B 12 deficiency (only group 1) at 3 months and 12 months vitamin B12 levels below the lower limit of normal
iron deficiency (only group 1) at 3 months and 12 months ferritin below the lower limit of normal
daily protein intake at 3 months and 12 months change in daily protein intake (entered into the app) in grams
protein malnutrition (only group 1) at 3 months and 12 months prealbumin below the lower limit of normal
zinc deficiency (only group 1) at 3 months and 12 months zinc below the lower limit of normal
Trial Locations
- Locations (1)
Ann-Cathrin D Koschker
🇩🇪Wuerzburg, Germany