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Active, Not Recruiting

NCT Number: NCT04768127

Adipositas Care & Health Therapy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AMC WolfartKlinik, Zentrum für Adipositas- und Metabolische Chirurgie, Gräfelfing, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

early aftercare

Other

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

mid-term to late aftercare

Other

This group begins the aftercare program 18 months post surgery.

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. General Quality of life

    Time frame: 18 months

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

  2. Bariatric Quality of life

    Time frame: 18 months

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

  3. Health-specific Quality of life

    Time frame: 18 months

    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)

  4. - Depression

    Time frame: 18 months

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

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

    Time frame: 18 months

    • Single dimensions of the modified King's Score
  6. Percentage of Patients with folic acid deficiency

    Time frame: 18 months

    • Measurement of folic acid (ng/ml); percentage of patients with values below the reference range
  7. Percentage of Patients with Vitamin B 12 deficiency

    Time frame: 18 months

    • Measurement of Vitamin B 12 (pg/ml); percentage of patients with values below the reference range
  8. Percentage of Patients with Vitamin B 1 deficiency

    Time frame: 18 months

    • Measurement of Vitamin B 1 (µg/l); percentage of patients with values below the reference range
  9. Percentage of Patients with Vitamin B 6 deficiency

    Time frame: 18 months

    • Measurement of Vitamin B 6 (µg/l); percentage of patients with values below the reference range
  10. Percentage of Patients with iron deficiency

    Time frame: 18 months

    • Measurement of ferritin (µg/l); percentage of patients with values below the reference range
  11. Percentage of Patients with protein deficiency

    Time frame: 18 months

    • Measurement of prealbumin (mg/dl); percentage of patients with values below the reference range
  12. Percentage of patients with symptoms of postoperative malnutrition based on 9 standardized questions

    Time frame: 18 months

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

    Time frame: 18 months

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

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

    Time frame: 18 months

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

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

    Time frame: 18 months

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

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

    Time frame: 18 months

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

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

    Time frame: 18 months

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

  18. Change in lean Body mass

    Time frame: 18 months

    • Body composition will be assessed by bioelectrical impedance Analysis measuring the percentage of lean Body mass
  19. Change in Phase angle

    Time frame: 18 months

    • Body composition will be assessed by bioelectrical impedance Analysis measuring the Phase angle
  20. average number of Sick days

    Time frame: 18 months

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

  21. - Patient adherence

    Time frame: 18 months

    number of attended appointments

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

    Time frame: 18 months

    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

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

    Time frame: 18 months

    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

  24. - Acceptance of the ACHT aftercare program

    Time frame: 18 months

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

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: ACHT

Important dates

Study start
2020
Primary completion
2022
Study completion
2025
First posted
Feb 24, 2021
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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