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

NCT06061406 | Active Not Recruiting

• 1 other identifier: BESmart 228/20
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Bariatric Surgery Candidate

Keywords

App; Empowerment; Obesity; bariatric surgery

Outcome Measures

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

  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 Outcomes (20)

• 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

• change in weight

  at 3 months and 12 months

• change in quality of life by SF-36

  at 3 months and 12 months

• change in obesity related quality of life by BQL

  at 3 months and 12 months

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

  at 3 months and 12 months

Study Arms (3)

group1

EXPERIMENTAL

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

group 2

EXPERIMENTAL

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

group 3

EXPERIMENTAL

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

Interventions

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.

group 2; group 3; group1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• current pregnancy

Sponsors & Collaborators

• Wuerzburg University Hospital: lead
• aycan Medical Systems LTD, Innere Aumuehlstr. 5, 97076 Wuerzburg , Germany: collaborator

Study Sites (1)

Ann-Cathrin D Koschker

Würzburg, 97080, Germany

Location

MeSH Terms

Conditions

Obesity; Alzheimer Disease; Empowerment

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Social Behavior; Behavior

Study Officials

• Ann-Cathrin D Koschker

  University Hospital Wuerzburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of outpatient clinic for diabetes and lipids

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: September 29, 2023
• Study Start: May 2, 2021
• Primary Completion: October 31, 2023
• Study Completion: June 1, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

DE (1)