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

Last updated: January 24, 2025
Sponsor: Gaia AG
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hypercholesterolemia

Treatment

lipodia

Clinical Study ID

NCT05988866
lipodia RCT 2025
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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

Study Design

Total Participants: 272
Treatment Group(s): 1
Primary Treatment: lipodia
Phase:
Study Start date:
January 22, 2025
Estimated Completion Date:
January 31, 2026

Connect with a study center

  • GAIA AG

    Hamburg, 22085
    Germany

    Active - Recruiting

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