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

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Bariatric Surgery Candidate
• Intervention / Treatment: Device: smart visit app

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Wuerzburg, Germany, 97080
    • Ann-Cathrin D Koschker

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group1; 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 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.
Experimental: group 2; 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; 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.
Experimental: group 3; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	at 12 months
change in weight	change in weight in kilograms	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	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	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)	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	at 3 months and 12 months
Eating behavior	measured by EDE-Q8 (Eating Disorder Examination Questionnaire Short Version)	at 3 months and 12 months
Number of contacts patient - center via app	Number of contacts between patients and center via app	at 3 months and 12 months
daily step counts	change in daily step counts as measured with a pedometer	at 3 months and 12 months
daily protein intake	change in daily protein intake (entered into the app) in grams	at 3 months and 12 months
daily calory intake	change in daily calory intake (entered into the app) in kcal	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	at 3 months and 12 months
body composition: body fat measured by bioelectrical impedance analysis	change in body fat (in %)	at 3 months and 12 months
body composition: phase angle measured by by bioelectrical impedance analysis	change in phase angle (in °)	at 3 months and 12 months
vitamin B 12 deficiency (only group 1)	vitamin B12 levels below the lower limit of normal	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)	at 3 months and 12 months
iron deficiency (only group 1)	ferritin below the lower limit of normal	at 3 months and 12 months
protein malnutrition (only group 1)	prealbumin below the lower limit of normal	at 3 months and 12 months
vitamin D deficiency (only group 1)	25-OH vitamin D below the lower limit of normal	at 3 months and 12 months
zinc deficiency (only group 1)	zinc below the lower limit of normal	at 3 months and 12 months

Collaborators and Investigators

• Sponsor: Wuerzburg University Hospital
• Collaborators: aycan Medical Systems LTD, Innere Aumuehlstr. 5, 97076 Wuerzburg , Germany
• Investigators: Principal Investigator: Ann-Cathrin D Koschker, University Hospital Wuerzburg

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2021
• Primary Completion (Actual): October 31, 2023
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: March 31, 2022
• First Submitted That Met QC Criteria: September 24, 2023
• First Posted (Actual): September 29, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; bariatric surgery; App; Empowerment
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: BESmart 228/20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No