Status:
ACTIVE_NOT_RECRUITING
Adipositas Care & Health Therapy
Lead Sponsor:
Wuerzburg University Hospital
Collaborating Sponsors:
Deutsche Stiftung für chronisch Kranke
Deutschen Gesellschaft für Allgemein- und Viszeralchirurgie e.V. (DGAV)
Conditions:
Patients After Metabolic-bariatric Surgery
Obesity, Morbid
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
ACHT - Adipositas Care and Health Therapy - is a structured, digitally-supported, cross-sectoral and close to home program developed for the postoperative care of patients following obesity surgery. T...
Detailed Description
In Germany, every second adult is overweight and almost one in four is obese - the trend is rising. Obesity is a chronic illness which significantly increases the risk of developing co-morbidities suc...
Eligibility Criteria
Inclusion
- relevant for all groups:
- patients who have already approved to have their data entered into the National Registry of metabolic and bariatric diseases (StuDoQ, DGAV)
- Sufficient knowledge of the German language to use the app, to communicate with the obesity case manager (obesity guide) and to fill out the questionnaires
- signed consent form
- group specific criteria:
- Intervention group I ("early aftercare"):
- Insured with the Allgemeine Ortskrankenkasse (AOK) Bayern
- Consent to participate in the selective contract
- The bariatric metabolic operation (sleeve gastrectomy, Roux-en-Y-gastric bypass) was carried out 3 weeks (+/- 10 days) before the entrance examination
- iOS or Android smartphone (operating system: iOS 11 or higher or Android 6 or higher) with internet access can be used for study
- Sufficient mobility to get to the aftercare practice regularly and to complete an exercise program
- Intervention Group II ("medium-term and late after care") recruited from control group I:
- Insured with the Allgemeine Ortskrankenkasse (AOK) Bayern
- Consent to participate in the selective contract
- The bariatric-metabolic operation (sleeve gastrectomy or Roux-en-Y-gastric bypass) was carried out 18 months (+/- 2 months) before time of recruitment
- Control group I (compared to early intervention):
- Insured with the Allgemeine Ortskrankenkasse (AOK) Bayern
- The bariatric metabolic operation was carried out 18 months (+/- 2 months) before time of recruitment
- Sufficient mobility (see intervention group, so that groups are comparable)
- Control group II (compared to late intervention):
- The bariatric metabolic operation was carried out 36 months (+/- 2 months) before the recruitment date
- Sufficient mobility (see intervention group, so that groups are comparable)
- The health insurance is irrelevant in this group
Exclusion
- State after a revision operation
- Planned two-stage surgical procedure
Key Trial Info
Start Date :
May 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
586 Patients enrolled
Trial Details
Trial ID
NCT04768127
Start Date
May 15 2020
End Date
December 31 2025
Last Update
April 8 2025
Active Locations (7)
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1
AMC WolfartKlinik, Zentrum für Adipositas- und Metabolische Chirurgie
Gräfelfing, Germany, 82166
2
Adipositaszentrum Klinikum Memmingen
Memmingen, Germany, 87700
3
Chirurgische Klinik München-Bogenhausen GmbH
München, Germany, 81679
4
Klinikum Nürberg
Nuremberg, Germany, 90419