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

August 18, 2025 updated by: Gaia AG

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

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

272

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Participants will receive access to the digital health intervention lipodia in addition to TAU.
No Intervention: Control group
Participants allocated to the control group will receive access to treatment as usual (TAU).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fasting LDL-C levels
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI
Time Frame: 6 months
6 months
Patients' activation
Time Frame: 6 months
Assessed with the total score of the PAM-13. Higher scores indicate higher patient activation (better outcome).
6 months
Fasting non-HDL-C levels
Time Frame: 6 months
6 months
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).
6 months
Fasting triglyceride levels
Time Frame: 6 months
6 months
Fasting HDL-C levels
Time Frame: 6 months
6 months
Fasting LDL-C levels
Time Frame: 3 months
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI
Time Frame: 3 months
3 months
Patients' activation
Time Frame: 3 months
Assessed with the total score of the PAM-13. Higher scores indicate higher patient activation (better outcome).
3 months
Fasting non-HDL-C levels
Time Frame: 3 months
3 months
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).
3 months
Fasting triglyceride levels
Time Frame: 3 months
3 months
Fasting HDL-C levels
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaia AG

Collaborators

University of Kiel

Investigators

  • Principal Investigator: Kamila Jauch-Chara, Prof., Christian-Albrechts-Universität zu Kiel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

August 3, 2023

First Submitted That Met QC Criteria

August 3, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 22, 2025

Last Update Submitted That Met QC Criteria

August 18, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lipodia RCT 2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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