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CompletedNCT05988866DIGICHOLUpdated Jul 7, 2026

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

An interventional study of lipodia in Hypercholesterolemia and Dyslipidemias, sponsored by Gaia AG. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by Gaia AG · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
278
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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)
02

Conditions studied

  • Hypercholesterolemia
  • Dyslipidemias

Keywords

  • LDL-C
  • digital intervention
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
278 participants (actual)

Study arms

  • 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.

    Behavioral: lipodia

  • No intervention
    Control group

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

Interventions

  • Behaviorallipodia

    Participants will receive access to the digital health intervention lipodia in addition to TAU.

05

What researchers measure

Primary outcomes

  1. Fasting LDL-C levels

    Time frame: 6 months

Secondary outcomes

  1. Patients' activation

    Assessed with the total score of the PAM-13. Higher scores indicate higher patient activation (better outcome).

    Time frame: 6 months

  2. Fasting non-HDL-C levels

    Time frame: 6 months

  3. Health-related quality of life

    Assessed with the total score of the AQoL-8D. Higher scores indicate higher quality of life (better outcome).

    Time frame: 6 months

  4. BMI

    Time frame: 6 months

  5. Fasting triglyceride levels

    Time frame: 6 months

  6. Fasting HDL-C levels

    Time frame: 6 months

  7. Fasting LDL-C levels

    Time frame: 3 months

Other outcomes

  1. Patients' activation

    Assessed with the total score of the PAM-13. Higher scores indicate higher patient activation (better outcome).

    Time frame: 3 months

  2. Fasting non-HDL-C levels

    Time frame: 3 months

  3. Health-related quality of life

    Assessed with the total score of the AQoL-8D. Higher scores indicate higher quality of life (better outcome).

    Time frame: 3 months

  4. BMI

    Time frame: 3 months

  5. Fasting triglyceride levels

    Time frame: 3 months

  6. Fasting HDL-C levels

    Time frame: 3 months

06

Study locations

1 site
  • GAIA AG
    Hamburg, 22085, Germany
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05988866
Lead sponsor
Gaia AG
Collaborators
University of Kiel
Responsible party
Sponsor
First posted
Aug 14, 2023
Start date
Feb 3, 2025
Primary completion
May 22, 2026
Completion
May 22, 2026
Last update
Jul 7, 2026

Study contacts

Kamila Jauch-Chara, Prof.
principal investigator · Christian-Albrechts-Universität zu Kiel

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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