Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels in Individuals With LDL-cholesterol Levels Above Recommended Targets for Reducing Cardiovascular Risk: Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18

• Diagnosis of hypercholesterolemia (ICD-10 E78.0, E78.2, E78.4, E78.5, E78.8, E78.9) confirmed by a laboratory test and physician diagnosis

• LDL-C levels above risk-adapted target

• TG levels \< 400 mg/dL

• Stability of potential drug treatment during the last 4 weeks

• Stability of potential hormonal treatment during the last 6 months

• Patient was made aware of lifestyle measures by GP or specialist

• Consent to participation

• Sufficient knowledge of the German language

Locations
Other Locations
Germany
GAIA AG
RECRUITING
Hamburg
Contact Information
Primary
Björn Meyer, PhD
bjoern.meyer@gaia-group.com
+49.176.1039.2337
Backup
Linda Betz, PhD
linda.betz@gaia-group.com
Time Frame
Start Date: 2025-02-03
Estimated Completion Date: 2026-01
Participants
Target number of participants: 272
Treatments
Experimental: Intervention group
Participants allocated to the intervention group will receive access to lipodia in addition to treatment as usual (TAU).~lipodia is a digital health application designed for individuals with hypercholesterinemia, accessible through a web browser. The application focuses on treatment methods derived health behavior change and cognitive behavioral therapy (CBT). Topics addressed by lipodia are activity planning and impulse control, dietary habits, physical activity, stress management, mood management, sleep management, weight management, as well as quitting smoking and drinking.~The program operates through interactive dialogues, which are accompanied by illustrations, audio recordings, motivating text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 365 days.
No_intervention: Control group
Participants allocated to the control group will receive access to treatment as usual (TAU).
Related Therapeutic Areas
Sponsors
Leads: Gaia AG
Collaborators: University of Kiel

This content was sourced from clinicaltrials.gov