Clinical trial

Adipositas Care & Health Therapy

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT04768127

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionPatients After Metabolic-bariatric Surgery, Obesity, Morbid

Full registry criteria

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

Treatments and study arms

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

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