AzTrials
AzTrials

Patients After Metabolic-bariatric SurgeryACHTNCT04768127

Adipositas Care & Health Therapy

A study testing early aftercare and mid-term to late aftercare in people with Patients After Metabolic-bariatric Surgery and Obesity, Morbid, run by Wuerzburg University Hospital at 7 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
early aftercare and mid-term to late aftercare
Could I receive a placebo?
No, everyone receives an active treatment
How many people
586 participants
Where
7 sitesGermany
Study dates
15 May 2020to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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"):
Show all 23Show fewer
  • 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

Who cannot join

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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Germany7 sites

  • AMC WolfartKlinik, Zentrum für Adipositas- und Metabolische Chirurgie

    Gräfelfing, 82166

  • Adipositaszentrum Klinikum Memmingen

    Memmingen, 87700

  • Chirurgische Klinik München-Bogenhausen GmbH

    München, 81679

  • Klinikum Nürberg

    Nuremberg, 90419

  • Sana Klinikum Offenbach GmbH

    Offenbach, 63069

  • Klinikum Passau

    Passau, 94032

  • Wuerzburg University Hospital

    Würzburg, 97080

Other trials in Germany

About this study

Official title: ACHT - Adipositas Care & Health Therapy Zur Strukturierten, sektorenübergreifenden Versorgung Nach Bariatrisch-metabolischer Operation

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.

Read the 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 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.

Being tested
early aftercare, mid-term to late aftercare
Keywords
bariatric surgery, patient adherence, post surgery care, morbid obesity, obesity surgery, obesity guide, aftercare program, electronic case file, obesity app, weight loss surgery
Medical subject headings
Obesity, Morbid, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • early aftercareOther

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

  • mid-term to late aftercareOther

    This group begins the aftercare program 18 months post surgery.

Study groups in NCT04768127
Study groupRoleWhat they receive
Early aftercare (intervention group 1)ExperimentalPatients 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
Receives: Other: early aftercare
Mid-term to long-term aftercare (intervention group 2)ExperimentalPatients 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.
Receives: Other: mid-term to late aftercare
control group 1 (early aftercare)No interventionAnalogous 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 interventionAnalogous 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 18 months

Secondary outcomes (24)

  1. General Quality of life

    Quality of life is measured by Short Form 36 (SF-36); Minimum 0 Points, Maximum 100 Points; higher values mean a better outcome

    Measured: 18 months

  2. Bariatric Quality of life

    Quality of life is measured by Bariatric Quality of life (BQL); Minimum 13 Points, Maximum 65 Points; higher values mean a better outcome

    Measured: 18 months

  3. Health-specific Quality of life

    Quality of life is measured by EuroQuol-5 dimensions (EQ-5D); each of the 5 dimensions has between 1 Point (no Limitation in that Dimension) and 5 Points (severe Limitation in that Dimension)

    Measured: 18 months

  4. - Depression

    Depression is measured by Patient Health Questionnaire 9 (PHQ-9 questionnaire); Minimum 0 Points, Maximum 27 Points, lower values mean better outcome

    Measured: 18 months

  5. - Single dimensions of the modified King's Score

    • Single dimensions of the modified King's Score

    Measured: 18 months

  6. Percentage of Patients with folic acid deficiency

    • Measurement of folic acid (ng/ml); percentage of patients with values below the reference range

    Measured: 18 months

  7. Percentage of Patients with Vitamin B 12 deficiency

    • Measurement of Vitamin B 12 (pg/ml); percentage of patients with values below the reference range

    Measured: 18 months

  8. Percentage of Patients with Vitamin B 1 deficiency

    • Measurement of Vitamin B 1 (µg/l); percentage of patients with values below the reference range

    Measured: 18 months

  9. Percentage of Patients with Vitamin B 6 deficiency

    • Measurement of Vitamin B 6 (µg/l); percentage of patients with values below the reference range

    Measured: 18 months

  10. Percentage of Patients with iron deficiency

    • Measurement of ferritin (µg/l); percentage of patients with values below the reference range

    Measured: 18 months

  11. Percentage of Patients with protein deficiency

    • Measurement of prealbumin (mg/dl); percentage of patients with values below the reference range

    Measured: 18 months

  12. Percentage of patients with symptoms of postoperative malnutrition based on 9 standardized questions

    • Postoperative nutritional status will be assessed via 9 questions from a standardized questionnaire (StuDoQ DGAV); questions can be answered by "yes" or "no"; number of questions answered by "yes"

    Measured: 18 months

  13. Percentage of Procedure-specific long term complications: Dumping syndrome

    percentage of patients with Dumping syndrome (Patients will be asked for symptoms)

    Measured: 18 months

  14. Percentage of Procedure-specific long term complications: gastric ulcers

    percentage of patients with gastric ulcers (Patients will be asked for symptoms and findings if endoscopy was performed)

    Measured: 18 months

  15. Percentage of Procedure-specific long term complications: gall stones

    percentage of patients with gall Stones (Patients will receive a sonography of the gall bladder)

    Measured: 18 months

  16. Percentage of Procedure-specific long term complications: internal hernia

    percentage of patients with internal hernia (Patients are asked if they had surgery for internal hernia)

    Measured: 18 months

  17. percentage of procedure-specific long term complications: anastomosis Stenosis

    percentage of Patients with anastomosis Stenosis (Patients will be asked for recurrent vomiting and if an endoscopic or surgical Intervention was performed)

    Measured: 18 months

  18. Change in lean Body mass

    • Body composition will be assessed by bioelectrical impedance Analysis measuring the percentage of lean Body mass

    Measured: 18 months

  19. Change in Phase angle

    • Body composition will be assessed by bioelectrical impedance Analysis measuring the Phase angle

    Measured: 18 months

  20. average number of Sick days

    Average number of Sick days in the past 12 months (information provided by the Patient and data of the respective health insurance)

    Measured: 18 months

  21. - Patient adherence

    number of attended appointments

    Measured: 18 months

  22. Percentage of patients reaching their Goal for steps per day

    Percentage of Patients achieving their treatment goal for steps per day, comparison between individual goal (defined according to the physical working capacity 120) and state at study inclusion

    Measured: 18 months

  23. Percentage of patients reaching their Treatment Goal for physical activity

    Percentage of Patients achieving their treatment goal for physical activity, comparison between individual goal (defined according to the physical working capacity 120) and state at study inclusion

    Measured: 18 months

  24. - Acceptance of the ACHT aftercare program

    • Acceptance of the ACHT aftercare program by patients and professionals (physicians, nutritionists) measured by a self-designed questionnaire

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2021
  2. Study start15 May 2020
  3. Primary completion30 Nov 2022
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
The study will compare two intervention groups (early intervention and later intervention) to two control groups.
Masking
None (open label)
Enrolment
586 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04768127
Sponsor's protocol ID
ACHT
Acronym
ACHT
Status last verified
Apr 2025
First submitted
16 Dec 2020
Last updated
8 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing early aftercare and mid-term to late aftercare in people with Patients After Metabolic-bariatric Surgery and Obesity, Morbid, run by Wuerzburg University Hospital at 7 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified King's Score (comparison between intervention group I and control group I resp. intervention group II and control group II) (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04768127.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in