Adipositas Care & Health Therapy

NCT04768127 | Active Not Recruiting

• 1 other identifier: ACHT
• Study Type: interventional
• Target: 586
• Locations: 1 country
• Sites: 7

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. 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.

Conditions

Patients After Metabolic-bariatric Surgery; Obesity, Morbid

Keywords

bariatric surgery; patient adherence; post surgery care; morbid obesity; obesity surgery; obesity guide; aftercare program; electronic case file; obesity app; weight loss surgery

Outcome Measures

Primary Outcomes (1)

• Modified King's Score (comparison between intervention group I and control group I resp. intervention group II and control group II)

  Primary endpoint will be the difference in the modified King's Score between intervention group I and control group I resp. intervention group II and control group II. The modified King's Score is a multifaceted sum score taking into account categories A to L (airways, BMI, cardiovascular, diabetes mellitus, economic, functional, gonadal/sexuality, health status, body image, junction (gastroesophageal), kidney, liver). For each category patients receive between 0 and 3 points describing the degree of impairment (0 Points: normal; 3 Points: severe impairment); the minimum score can be 0, maximum sum score can thus be 36.

  18 months

Secondary Outcomes (24)

• General Quality of life

  18 months

• Bariatric Quality of life

  18 months

• Health-specific Quality of life

  18 months

• - Depression

  18 months

• - Single dimensions of the modified King's Score

  18 months

Study Arms (4)

Early aftercare (intervention group 1)

EXPERIMENTAL

Patients in this group will begin the ACHT program immediately after their bariatric metabolic operation. 3 weeks post surgery, they will attend the initial examination and meet their case manager. The obesity guide will then set up an electronic case file for the patient and introduce the patient to the obesity app. Through the next 18 months the obesity guide will monitor the patient's therapeutic success and adherence to the therapeutic goals. In month 2 patients visit a sports physician who assesses their mobility and physical capacity to compile a personal training plan, which will be uploaded onto the patient's case file and thus be available to the patient via the app. In months 3,6,9.12 and 18, patients will attend their aftercare appointments at specially trained ACHT physicians, where they will be physically examined by a physician and receive tailored dietary advice from a nutritional advisor. In month 18 patients revisit the surgical centre for the follow-up examination

Other: early aftercare

Mid-term to long-term aftercare (intervention group 2)

EXPERIMENTAL

Patients in this group first visit the study center 18 months after their bariatric surgery for the initial examination and start the program in month 19 post-op. At the center, they will meet their obesity guide who will set up an electronic case file for the patient and introduce the patient to the obesity app. Throughout the next 18 months, the obesity guide will monitor the patient's therapeutic success and adherence to the therapeutic goals. In month 19 post-surgery, patients visit a sports physician who assesses their mobility and devises a personal training plan. This plan will be uploaded onto the patient's case file and made available to the patient via the app. In months 19,21,24, 30 and 36, patients attend their aftercare appointments at specially trained ACHT physicians, where they will be physically examined and receive tailored dietary advice. In month 36, patients will be reexamined at the study center.

Other: mid-term to late aftercare

control group 1 (early aftercare)

NO INTERVENTION

Analogous to intervention group I, patients in this group are invited to the study center after verbal and written information. These patients will attend the one-off evaluation examination (18 months after the operation) at the obesity centre. If interested, patients in this group can be included in intervention group II until the required number of cases (140 patients) has been reached.

control group 2 (mid-term to long-term aftercare)

NO INTERVENTION

Analogous to intervention group II, patients in this group are invited to the study center after verbal and written information. These patients will attend the one-off evaluation examination at the study center 36 months after the operation.

Interventions

early aftercare OTHER

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

Early aftercare (intervention group 1)

mid-term to late aftercare OTHER

This group begins the aftercare program 18 months post surgery.

Mid-term to long-term aftercare (intervention group 2)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• State after a revision operation
• Planned two-stage surgical procedure

Sponsors & Collaborators

• Wuerzburg University Hospital: lead
• Deutsche Stiftung für chronisch Kranke: collaborator
• Deutschen Gesellschaft für Allgemein- und Viszeralchirurgie e.V. (DGAV): collaborator
• AOK Bayern: collaborator
• Kassenärztliche Vereinigung Bayern: collaborator
• symeda GmbH: collaborator
• AMC Wolfartklinik Gräfelfing: collaborator
• Schön Klinik Nürnberg Fürth: collaborator
• Dr. Lubos Kliniken Bogenhausen: collaborator
• Klinikum Memmingen: collaborator
• Klinikum Passau: collaborator
• Klinikum Nürnberg: collaborator
• Helmholtz Zentrum München: collaborator

Study Sites (7)

AMC WolfartKlinik, Zentrum für Adipositas- und Metabolische Chirurgie

Gräfelfing, 82166, Germany

Location

Adipositaszentrum Klinikum Memmingen

Memmingen, 87700, Germany

Location

Chirurgische Klinik München-Bogenhausen GmbH

München, 81679, Germany

Location

Klinikum Nürberg

Nuremberg, 90419, Germany

Location

Sana Klinikum Offenbach GmbH

Offenbach, 63069, Germany

Location

Klinikum Passau

Passau, 94032, Germany

Location

Wuerzburg University Hospital

Würzburg, 97080, Germany

Location

MeSH Terms

Conditions

Obesity, Morbid; Patient Compliance

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Bettina Zippel-Schultz, PhD

  Deutsche Stiftung für chronisch Kranke

  STUDY DIRECTOR

• Martin Fassnacht, MD

  Wuerzburg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Martin Fassnacht (Head of Endocrinolgy)

Model Details: The study will compare two intervention groups (early intervention and later intervention) to two control groups.

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: February 24, 2021
• Study Start: May 15, 2020
• Primary Completion: November 30, 2022
• Study Completion: December 31, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

DE (7)