Trials Sponsors Conditions Drugs Pricing

Conditions

Obesity, Morbid Patients After Metabolic-bariatric Surgery

Keywords

bariatric surgerypatient adherencepost surgery caremorbid obesityobesity surgeryobesity guideaftercare programelectronic case fileobesity appweight 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

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.

Interventions

early aftercareOther

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

Early aftercare (intervention group 1)

mid-term to late aftercareOther

This group begins the aftercare program 18 months post surgery.

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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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)

Sponsors & Collaborators

Deutsche Stiftung für chronisch Kranke
Type not reportedcollaborator
Kassenärztliche Vereinigung Bayern
Type not reportedcollaborator

Study Sites (7)

AMC WolfartKlinik, Zentrum für Adipositas- und Metabolische Chirurgie

Gräfelfing, 82166, Germany

Adipositaszentrum Klinikum Memmingen

Memmingen, 87700, Germany

Chirurgische Klinik München-Bogenhausen GmbH

München, 81679, Germany

Klinikum Nürberg

Nuremberg, 90419, Germany

Sana Klinikum Offenbach GmbH

Offenbach, 63069, Germany

Klinikum Passau

Passau, 94032, Germany

Wuerzburg University Hospital

Würzburg, 97080, Germany

MeSH Terms

Conditions

Obesity, MorbidPatient Compliance

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

Bettina Zippel-Schultz, PhD
Deutsche Stiftung für chronisch Kranke
STUDY DIRECTOR
Martin Fassnacht, MD
Wuerzburg University Hospital
PRINCIPAL INVESTIGATOR

Enrollment

586 participants (actual enrollment reported by the registry).

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)

Study Record Dates

First Submitted

December 16, 2020

First Posted

February 24, 2021

Study Start

May 15, 2020

Adipositas Care & Health Therapy

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (24)

Study Arms (4)

Early aftercare (intervention group 1)

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

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

control group 1 (early aftercare)

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

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (24)

Study Arms (4)

Early aftercare (intervention group 1)

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

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

control group 1 (early aftercare)

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

You may not qualify if:

Source record

Locations