Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels

Not Applicable

Recruiting

• Conditions: Hypercholesterolemia; Dyslipidemias

• Registration Number: NCT05988866
• Lead Sponsor: Gaia AG

Brief 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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-03
• Study First Submitted QC: 2023-08-03
• Study First Posted: 2023-08-14
• Status Verified: 2025-01
• Study Start: 2025-01-22
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-03-25
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 272

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fasting LDL-C levels	6 months

Secondary Outcome Measures

Name	Time	Method
Patients' activation	6 months	Assessed with the total score of the PAM-13. Higher scores indicate higher patient activation (better outcome).
Fasting non-HDL-C levels	6 months
Health-related quality of life	6 months	Assessed with the total score of the AQoL-8D. Higher scores indicate higher quality of life (better outcome).
BMI	6 months
Fasting triglyceride levels	6 months
Fasting HDL-C levels	6 months
Fasting LDL-C levels	3 months

Trial Locations

Locations (1)

GAIA AG; 🇩🇪 Hamburg, Germany