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Clinical Trials in Germany / NCT04768127
Active, not recruiting Not applicable

Adipositas Care & Health Therapy

NCT04768127 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2020-05-15
Last updated
2025-04-08

Condition(s) studied

Patients After Metabolic-bariatric SurgeryObesity, Morbid

Investigational drug(s) / intervention(s)

early aftercaremid-term to late aftercare

early aftercare: This group begins the aftercare program immediately after their bariatric surgery.

mid-term to late aftercare: This group begins the aftercare program 18 months post surgery.

Study 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. The aim is to ensure the long-term success of therapy following bariatric surgery. ACHT was selected by the Federal Joint Commission for support under the Innovation Fund. The project started in July 2019 and will end in December 2022.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 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 Criteria: * State after a revision operation * Planned two-stage surgical procedure

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
AMC WolfartKlinik, Zentrum für Adipositas- und Metabolische Chirurgie Gräfelfing Germany
Adipositaszentrum Klinikum Memmingen Memmingen Germany
Chirurgische Klinik München-Bogenhausen GmbH München Germany
Klinikum Nürberg Nuremberg Germany
Sana Klinikum Offenbach GmbH Offenbach Germany
Klinikum Passau Passau Germany
Wuerzburg University Hospital Würzburg Germany

More Wuerzburg University Hospital trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04768127 on ClinicalTrials.gov ↗ ← All trials in Germany