Actively Recruiting
Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels
Led by Gaia AG · Updated on 2025-08-22
272
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
Sponsors
G
Gaia AG
Lead Sponsor
U
University of Kiel
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to find out if lipodia, a digital health intervention, can help lower cholesterol levels and improve other health measures in adults with high cholesterol. The main questions it aims to answer are: * Does lipodia, together with regular treatment, lower LDL cholesterol (bad cholesterol) better than regular treatment alone? * Does lipodia help improve other health outcomes, like how confident participants feel in managing their health? Researchers will compare two groups: * Intervention group: Participants use the lipodia intervention and continue their usual treatment. * Control group: Participants continue with their usual treatment only. Participants will: * Fill out questionnaires online and visit a certified lab at the start of the study, after 3 months, and after 6 months * Have blood tests at each lab visit to check their cholesterol and other blood fat levels * Continue with their usual treatment (both groups) and use lipodia, a digital health app, for six months (intervention group only)
CONDITIONS
Official Title
Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with hypercholesterolemia confirmed by laboratory test and physician
- LDL cholesterol levels above risk-adapted target
- Triglyceride levels below 400 mg/dL
- Stable drug treatment for at least 4 weeks
- Stable hormonal treatment for at least 6 months
- Informed about lifestyle measures by healthcare provider
- Provided consent to participate
- Sufficient knowledge of the German language
You will not qualify if you...
- Homozygous Familial Hypercholesterolemia
- Hyperlipidemia type III
- Receiving plasmapheresis treatment
- Lipoprotein(a) levels above 50 mg/dL
- Current or planned pregnancy during study
- Planned major surgery during study
- Liver dysfunction
- End-stage kidney failure
- Other systemic conditions interfering with participation
- Planned changes to drug or hormonal treatment within 6 months
- Use of another digital intervention for cholesterol management in the past
AI-Screening
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Trial Site Locations
Total: 1 location
1
GAIA AG
Hamburg, Germany, 22085
Actively Recruiting
Research Team
B
Björn Meyer, PhD
CONTACT
L
Linda Betz, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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