Enhanced health intelligence for personal behavioral strategies in everyday life - 2nd application scenario

• Conditions: Overweight; E66.0; Obesity due to excess calories

• Registration Number: DRKS00030903
• Lead Sponsor: Bodymed AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-04
• Study Completion: 2023-03-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

BMI = 25.0 kg/m², i.e. overweight or obesity
- Regular participation in the Bodymed programs (Bodymed nutrition program, liver fasting according to Dr. Worm®).
- Ownership of an Android smartphone, at least Android version 7, alternatively ownership of an Apple device (iOs operating system).

Exclusion Criteria

- Eating disorders
- Cancer diseases
- Diabetic nephropathy or renal insufficiency only after consultation with the specialist physician in charge
- Protein utilization disorders (e.g. phenylketonuria)
- Cachexia
- Decompensated liver cirrhosis
- Pregnancy (from the 3rd trimester)
- Breastfeeding
- Alcohol abuse
- Use of the following medications: Amiodarone, tamoxifen, corticosteroids, methotrexate, tetracyclines, valproic acid
- Chemotherapy (CASH; 5-FU, taxanes, platinum-containing chemotherapeutic agents).

In consultation with the study physician, the following criteria may also lead to exclusion from the study:
- Nicotine abuse
- intake of appetite suppressants, herbal gastrointestinal preparations, homeopathics

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Acquisition of various behavioral parameters as well as biomarkers to create a digital twin via smartphone and smartwatch.<br>--> Derivation of behavior patterns<br>--> Generation of recommendations for behavioral change<br><br>Change in behavioral patterns and change in body weight after 12 weeks

Secondary Outcome Measures

Name	Time	Method
ong-term and sustainable improvement of health and nutrition behavior through the support in everyday life by the use of digital applications.<br>Successful weight reduction with decrease in fat mass and increase in metabolically active mass (musculature).