Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels
DIGICHOL
1 other identifier
interventional
272
1 country
1
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedStudy Start
First participant enrolled
February 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedAugust 22, 2025
August 1, 2025
11 months
August 3, 2023
August 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fasting LDL-C levels
6 months
Secondary Outcomes (7)
Patients' activation
6 months
Fasting non-HDL-C levels
6 months
Health-related quality of life
6 months
BMI
6 months
Fasting triglyceride levels
6 months
- +2 more secondary outcomes
Other Outcomes (6)
Patients' activation
3 months
Fasting non-HDL-C levels
3 months
Health-related quality of life
3 months
- +3 more other outcomes
Study Arms (2)
Intervention group
EXPERIMENTALParticipants 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.
Control group
NO INTERVENTIONParticipants allocated to the control group will receive access to treatment as usual (TAU).
Interventions
Participants will receive access to the digital health intervention lipodia in addition to TAU.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gaia AGlead
- University of Kielcollaborator
Study Sites (1)
GAIA AG
Hamburg, 22085, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kamila Jauch-Chara, Prof.
Christian-Albrechts-Universität zu Kiel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2023
First Posted
August 14, 2023
Study Start
February 3, 2025
Primary Completion
January 1, 2026
Study Completion
January 1, 2026
Last Updated
August 22, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share