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Completed

NCT Number: NCT06061406

BE Smart - Bariatric Patient - Empowerment in the Preparation and Follow-up of Bariatric Surgery Using the Smartvisit App (BESmart)

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

General inclusion criteria:

  • Smartphone available (iOS or Android with sufficient version of the operating system).
  • Age >/= 18 years
  • Sufficient language skills to answer the questionnaires

Additional group specific inclusion criteria:

Group 1 (bariatric-metabolic surgery):

  • Bariatric-metabolic surgery (sleeve gastrectomy, Roux-Y gastric bypass, omega-loop bypass) at least 24 months ago.

Group 2 (multimodal treatment):

  • Participation in a full or partial (if primary indication) multimodal approach.

Group 3 (conservative therapy):

  • BMI 28-34.9 kg/m2
  • No planned bariatric-metabolic surgery
  • Desire for conservative weight reduction

Exclusion criteria

  • current pregnancy

Treatment and study plan

smart visit app

Device

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

    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)

  2. change in weight

    Time frame: at 3 months and 12 months

    change in weight in kilograms

  3. change in quality of life by SF-36

    Time frame: 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

  4. change in obesity related quality of life by BQL

    Time frame: 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

  5. change in quality of life by EQ-5D-5L

    Time frame: at 3 months and 12 months

    measured by EQ-5D-5L questionnaire (European Quality of Life 5 Dimensions 5 Level Version)

  6. Depressive symptoms

    Time frame: 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

  7. Eating behavior

    Time frame: at 3 months and 12 months

    measured by EDE-Q8 (Eating Disorder Examination Questionnaire Short Version)

  8. Number of contacts patient - center via app

    Time frame: at 3 months and 12 months

    Number of contacts between patients and center via app

  9. daily step counts

    Time frame: at 3 months and 12 months

    change in daily step counts as measured with a pedometer

  10. daily protein intake

    Time frame: at 3 months and 12 months

    change in daily protein intake (entered into the app) in grams

  11. daily calory intake

    Time frame: at 3 months and 12 months

    change in daily calory intake (entered into the app) in kcal

  12. walking distance in 6 minute walk test

    Time frame: at 3 months and 12 months

    change in walking distance in the 6 minute walk test in meters

  13. body composition: body fat measured by bioelectrical impedance analysis

    Time frame: at 3 months and 12 months

    change in body fat (in %)

  14. body composition: phase angle measured by by bioelectrical impedance analysis

    Time frame: at 3 months and 12 months

    change in phase angle (in °)

  15. vitamin B 12 deficiency (only group 1)

    Time frame: at 3 months and 12 months

    vitamin B12 levels below the lower limit of normal

  16. folic acid deficiency (only group 1)

    Time frame: 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)

  17. iron deficiency (only group 1)

    Time frame: at 3 months and 12 months

    ferritin below the lower limit of normal

  18. protein malnutrition (only group 1)

    Time frame: at 3 months and 12 months

    prealbumin below the lower limit of normal

  19. vitamin D deficiency (only group 1)

    Time frame: at 3 months and 12 months

    25-OH vitamin D below the lower limit of normal

  20. zinc deficiency (only group 1)

    Time frame: at 3 months and 12 months

    zinc below the lower limit of normal

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Collaborators

  • aycan Medical Systems LTD, Innere Aumuehlstr. 5, 97076 Wuerzburg , Germany

Registry information

Acronym: BESmart

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Sep 29, 2023
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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