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Completed

NCT Number: NCT05988866

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

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)

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GAIA AG

Hamburg, 22085, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lipodia

Behavioral

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

Primary outcomes

  1. Fasting LDL-C levels

    Time frame: 6 months

Secondary outcomes

  1. Patients' activation

    Time frame: 6 months

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

  2. Fasting non-HDL-C levels

    Time frame: 6 months

  3. Health-related quality of life

    Time frame: 6 months

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

  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

    Time frame: 3 months

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

  2. Fasting non-HDL-C levels

    Time frame: 3 months

  3. Health-related quality of life

    Time frame: 3 months

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

  4. BMI

    Time frame: 3 months

  5. Fasting triglyceride levels

    Time frame: 3 months

  6. Fasting HDL-C levels

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Gaia AG

Industry

Collaborators

  • University of Kiel

Registry information

Official study title

Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels in Individuals With LDL-cholesterol Levels Above Recommended Targets for Reducing Cardiovascular Risk: Randomized Controlled Trial

Acronym: DIGICHOL

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2023
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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