ClinicalTrials.gg
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

Where this study stands

Counted across the records on this site · 2026-11-12

Among 81 studies in Hypercholesterolemia with a site in Germany — 6 open to participants now, 11 under way, 7 of them phase 3. Hypercholesterolemia · Germany.

Enrollment
39th of 74
278 · median 306
Started
2025
with 1 other
No phase
14 of 81
none open now
Registered
71st of 81
by date

Among the 81 studies in Hypercholesterolemia with a site in Germany, this one is the 39th largest by enrollment of the 74 interventional ones that give a count, is one of 2 that started in 2025, is one of 14 with no phase, and was the 71st registered.

Hypercholesterolemia

1,175 studies on the registry are indexed under Hypercholesterolemia; 93 are open to participants now.

This study's enrollment of 278 is above the median of 110 across 975 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Open to participants now

6 of the 81 studies in Hypercholesterolemia with a site in Germany are open now, in 12 countries. Each count lists the studies.

All 6 open studies →

Who these studies take

Of the 55 Hypercholesterolemia studies recruiting now, 23 (42%) set no upper age limit and 20 (36%) stop at 75 or younger; 9 take children under 18; 11 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 81 studies in Hypercholesterolemia with a site in Germany, or all of them as a file.
02

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)
03

Conditions studied

  • Hypercholesterolemia
  • Dyslipidemias

Keywords

  • LDL-C
  • digital intervention
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
05

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.

06

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

07

Study locations

1 site
  • GAIA AG
    Hamburg, 22085, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2025 to primary completion in May 2026, 15 months.

Of 151 interventional studies with no phase under Hypercholesterolemia, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's 15 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 3, 2023
First posted
Aug 14, 2023
StartActual
Feb 3, 2025
Primary completionActual
May 22, 2026
CompletionActual
May 22, 2026
Last update
Jul 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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