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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06061406
Acronym
BESmart
Enrollment
100
Registered
2023-09-29
Start date
2021-05-02
Completion date
2024-06-30
Last updated
2026-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate, Obesity

Keywords

App, Empowerment, Obesity, bariatric surgery

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.

Interventions

DEVICEsmart 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.

Sponsors

Wuerzburg University Hospital
Lead SponsorOTHER
aycan Medical Systems LTD, Innere Aumuehlstr. 5, 97076 Wuerzburg , Germany
CollaboratorUNKNOWN

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
satisfaction with and use of smart visit app designed for obesity them self-manage their condition. Analysis of all 3 groups cumulated. Coprimary endpointat 3 monthsacceptance: 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

MeasureTime frameDescription
walking distance in 6 minute walk testat 3 months and 12 monthschange in walking distance in the 6 minute walk test in meters
body composition: body fat measured by bioelectrical impedance analysisat 3 months and 12 monthschange in body fat (in %)
body composition: phase angle measured by by bioelectrical impedance analysisat 3 months and 12 monthschange in phase angle (in °)
vitamin B 12 deficiency (only group 1)at 3 months and 12 monthsvitamin B12 levels below the lower limit of normal
folic acid deficiency (only group 1)at 3 months and 12 monthsfolic acid levels below the lower limit of normal, ferritin, hemoglobin, prealbumin, 25-OH vitamin D, zinc (only group 1)
iron deficiency (only group 1)at 3 months and 12 monthsferritin below the lower limit of normal
protein malnutrition (only group 1)at 3 months and 12 monthsprealbumin below the lower limit of normal
vitamin D deficiency (only group 1)at 3 months and 12 months25-OH vitamin D below the lower limit of normal
zinc deficiency (only group 1)at 3 months and 12 monthszinc below the lower limit of normal
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 monthsacceptance: 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 weightat 3 months and 12 monthschange in weight in kilograms
change in quality of life by SF-36at 3 months and 12 monthsmeasured by SF-36 (short form-36) questionnaire, z-transformed scale, 0 meaning worst possible quality of life, 100 meaning best possible quality of life
change in obesity related quality of life by BQLat 3 months and 12 monthsmeasured by BQL (bariatric quality of life) questionnaire index, 0 meaning worst possible quality of life, 100 meaning best possible quality of life
change in quality of life by EQ-5D-5Lat 3 months and 12 monthsmeasured by EQ-5D-5L questionnaire (European Quality of Life 5 Dimensions 5 Level Version)
Depressive symptomsat 3 months and 12 monthsmeasured by PHQ-9 questionnaire (Public Health Questionnaire-9), 0 meaning least possible depressive symptoms, 27 meaning worst possible depressive symptoms
Eating behaviorat 3 months and 12 monthsmeasured by EDE-Q8 (Eating Disorder Examination Questionnaire Short Version)
Number of contacts patient - center via appat 3 months and 12 monthsNumber of contacts between patients and center via app
daily step countsat 3 months and 12 monthschange in daily step counts as measured with a pedometer
daily calory intakeat 3 months and 12 monthschange in daily calory intake (entered into the app) in kcal
daily protein intakeat 3 months and 12 monthschange in daily protein intake (entered into the app) in grams

Countries

Germany

Contacts

PRINCIPAL_INVESTIGATORAnn-Cathrin D Koschker

Wuerzburg University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 27, 2026