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

Not Applicable

Recruiting

• Conditions: Hypercholesterolemia; Dyslipidemias
• Interventions: Behavioral: lipodia

• 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

Arm && Interventions

Group	Intervention	Description
Intervention group	lipodia	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.

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