RecruitingNAINTERVENTIONAL

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

This study is investigating if a new digital health app, Lipodia, can help people with high cholesterol reduce their LDL (or 'bad') cholesterol. High cholesterol is a common condition where you have too much fatty substance in your blood, which can lead to health problems. The study wants to see if using the Lipodia app alongside your regular treatment works better than just having your usual care. Researchers will also check if the app helps people feel more confident about managing their health. Participants will be split into two groups: one uses the app and continues their usual treatment, and the other just continues their usual treatment. Everyone will have some blood tests and fill out online questionnaires over six months.

At a glance

Status

Recruiting

Phase

Sponsor

Gaia AG

Enrolment target

272

Start

03 Feb 2025

Estimated completion

01 Jan 2026

Hypercholesterolemia Dyslipidemias

What is this study about?

This study aims to discover if a digital health app called Lipodia can be a helpful tool for adults living with high cholesterol. High cholesterol means you have too much of a fatty substance in your blood, which can contribute to serious health issues if not managed. Your doctor might talk about 'LDL cholesterol,' which is often called 'bad cholesterol' because high levels of it are linked to a higher risk of heart problems among other things. While many people manage their cholesterol with medication and lifestyle changes, this study explores whether an app could provide extra support.

The main goal is to find out if using the Lipodia app, along with your usual medical treatments, can lower your LDL cholesterol more effectively than just sticking to your usual treatment alone. Researchers are also interested in whether the app helps people feel more in control and confident about managing their own health and condition. By comparing two groups – one using the app plus their usual care, and one just on usual care – the study hopes to understand the app's potential benefits.

Taking part would involve regular check-ups, including blood tests to measure cholesterol, and completing some online questionnaires over a six-month period. All participants will continue their current medical treatment, and those in the app group will use Lipodia during this time. The study wants to make sure people with high cholesterol have the best possible tools to manage their health effectively.

Key takeaways

The study explores if a new app helps lower 'bad' cholesterol.
It lasts for six months and involves blood tests and questionnaires.
All participants continue their usual cholesterol treatment.
One group uses the app, the other doesn't, to compare results.
Aims to improve health confidence as well as cholesterol levels.

Who may be eligible?

To be able to join this study, you must be 18 years old or over and have been diagnosed with high cholesterol by a doctor. Your LDL (bad) cholesterol levels need to be above what your doctor considers healthy for you, but your triglyceride levels (another type of fat in your blood) must be below a certain level. It's important that any medications you're taking for your cholesterol, or any hormone treatments, have been stable for a certain amount of time before you start the study.

You also need to understand German well enough for the study materials and have already discussed lifestyle changes with your GP or a specialist. You won't be able to join if you have certain rare genetic types of high cholesterol that don't usually respond well to lifestyle changes, or if you're undergoing specific treatments like plasmapheresis.

Other reasons you might not be able to join include being pregnant or planning to get pregnant, needing major surgery soon, or if you have severe kidney or liver problems. If you're planning to change your cholesterol or hormone medicines in the next six months, or have used another digital app for your cholesterol recently, you also won't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with high cholesterol by a doctor?
Are your cholesterol medications stable (no changes in the last 4 weeks)?
Are you not currently pregnant or planning to be during the next 6 months?
Do you have a good understanding of German?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it will last for six months. You'll be assigned to one of two groups. One group will continue with their usual medical treatment for high cholesterol and will also use the Lipodia digital health app. The other group will simply continue their usual medical treatment without using the app.

Regardless of which group you're in, you will need to complete online questionnaires and visit a certified lab three times: once at the very beginning of the study, then again after three months, and finally after six months. At each of these lab visits, you'll have blood tests taken to check your cholesterol and other fat levels in your blood. You will continue to take any prescribed medications as usual throughout the entire six-month study period.

Potential risks and benefits

Participating in this study might offer you the chance to try a new digital health app designed to help manage high cholesterol, potentially leading to lower "bad" cholesterol levels and feeling more confident about your health. However, there's no guarantee the app will benefit you personally, and some people might not see any changes. The main risks involve the inconvenience of lab visits and questionnaires, as well as the usual risks associated with routine blood tests, such as minor bruising. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

GAIA AG
Verified postcode
Hamburg, Germany· Recruiting

Common questions

What is 'LDL cholesterol'?

LDL cholesterol is often called 'bad' cholesterol. High levels of it can increase your risk of heart problems.

What is the Lipodia app?

Lipodia is a digital health app that the study is testing to see if it can help people manage their high cholesterol.

Will I have to stop my current medication?

No, both groups in the study will continue with their usual medical treatment for high cholesterol.

How long does the study last?

The study lasts for six months in total.

Do I have to speak German to join?

Yes, you need to understand German well enough to take part in the study.

How to find out more

Björn Meyer, PhD

bjoern.meyer@gaia-group.com +49.176.1039.2337 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.