Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Obesity Morbid
  • Patients After Metabolic-bariatric Surgery
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The study will compare two intervention groups (early intervention and later intervention) to two control groups.Masking: None (Open Label)Primary Purpose: Health Services Research

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 such as cardiovascular and joint diseases, cancer and diabetes. In addition to those functional and hea...

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 such as cardiovascular and joint diseases, cancer and diabetes. In addition to those functional and health limitations, many people are stigmatised which can lead to social exclusion and a reduced quality of life. Available conservative therapies do not always lead to sufficient, long-term weight loss. In those cases and if the disease is very pronounced, an obesity surgery (bariatric-metabolic surgery) can help. In order to ensure its success, patients require long-term after care following surgery. Currently, there are no necessary outpatient care standards and provisions. Inpatient obesity centres try to compensate for this with their own structures and limited resources, but are already reaching their limits. The aim of the ACHT project is to ensure long-term therapeutic success after an operation. This is done through a digitally supported, structured, cross-sectoral and close-to-home aftercare program. Obesity case managers (obesity guides) coordinate the aftercare process and monitor the therapy goals. A digital case file links patients, case managers, resident doctors and obesity centers. Individual exercise goals, nutritional advice and psychological support are part of ACHT. ACHT is connected to quality assurance measures of a medical society. Four groups are compared in the ACHT study. One group begins their 18 months ACHT aftercare program directly after the operation, another group 18 months after the operation. These two groups are compared to patients who receive standard care. Through these two intervention groups, we hope to examine the long-term effects of the program within the given time constraints of the study. ACHT is funded for three and a half years by the Federal Joint Committee as part of the Innovation Fund with approx. 4.5 million euros.

Tracking Information

NCT #
NCT04768127
Collaborators
  • Deutsche Stiftung für chronisch Kranke
  • Deutschen Gesellschaft für Allgemein- und Viszeralchirurgie e.V. (DGAV)
  • AOK Bayern
  • Kassenärztliche Vereinigung Bayern
  • symeda GmbH
  • AMC Wolfartklinik Gräfelfing
  • Schön Klinik Nürnberg Fürth
  • Dr. Lubos Kliniken Bogenhausen
  • Klinikum Memmingen
  • Klinikum Passau
  • Klinikum Nürnberg
  • Helmholtz Zentrum München
Investigators
Study Director: Bettina Zippel-Schultz, PhD Deutsche Stiftung für chronisch Kranke Principal Investigator: Martin Fassnacht, MD Wuerzburg University Hospital