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

Gaia AG

Status: Enrolling

Conditions: Dyslipidemias; Hypercholesterolemia

Treatments: Behavioral: lipodia

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05988866

lipodia RCT 2025

Details and patient eligibility

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)

Enrollment: 272 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• 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

Exclusion criteria

• Homozygous Familial Hypercholesterolemia (FH), given that it is a genetic condition which is relatively unresponsive to lifestyle changes
• Hyperlipidemia type III, given that it is a genetic condition which is relatively unresponsive to lifestyle changes
• Patients receiving plasmapheresis
• Lp(a) > 50 mg/dL
• current pregnancy or planned pregnancy during the study period
• planned major operations
• liver dysfunction
• end-stage renal failure
• other systemic conditions that might interfere with successful study participation
• Plans to change drug (including hormonal) treatment in the upcoming 6 months
• Use of another digital intervention for hypercholesterolemia/dyslipidemia in the past

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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272 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: lipodia

Control group

No Intervention group

Description:

Participants allocated to the control group will receive access to treatment as usual (TAU).