The effect of the Happi Liver mobile health application on the reduction of non-alcoholic fatty liver disease

Non-alcoholic fatty liver disease (NAFLD) is the most important liver disease
in Western society. The disease is mainly caused by Western lifestyles leading
to overweight and obesity (50% of the Dutch adult population is overweight and
15% of these are obese). Fatty liver disease is an accumulation of fat in the
liver cells. Excess fat prevents the liver from functioning properly and
disturbs the metabolism, among other things. The cell packed with fat cannot
process the substances absorbed from the intestine as well as it should. This
leads to inflammation in the liver but also in the entire body. Fats can no
longer be packed and processed properly, which plays a role in
arteriosclerosis. If fatty liver disease exists for a long time, even without
complaints, a chronic inflammation of the liver can develop. This can lead to
scar tissue, which is an increased risk of developing cirrhosis. In addition,
the inflammation of the liver can also lead to the development or worsening of
diabetes, cardiovascular disease and cancer.
To date, no drugs have been registered for the treatment of fatty liver.
Therefore, treatment focuses mainly on lifestyle changes, as this is the basis
from which fatty liver develops. Previous research has shown that a reduction
in weight is effective: 3 to 5% reduces fatty liver, 7% reduces inflammation,
and 10% reduces scar tissue. Lifestyle modification is thus the first and most
important step in stopping the development of liver cirrhosis and other
complications. However, lifestyle changes are difficult and often people fall
back into their old, unhealthy habits. Support is therefore essential and the
use of a smartphone application (app) could be a solution.

The purpose of this study is to determine the effect of using the Happi Liver
application on the course of the liver disease non-alcoholic fatty liver
disease (NAFLD).

Eligible subjects already screened for NAFLD in previous studies will be asked
to participate in the study. After signing of the IFC they will be randomized
in either the control group that will receive standard of care or the
intervention group that will use the Happi liver mobile application. The Castor
EDC program will perform the randomization. Castor uses a validated variable
block randomization model that ensures true randomness during allocation. The
follow-up time for both control and app-group is one year and both groups are
monitored parallel.

The intervention in the app group consists of asking people to use this
application during their follow-up time.

Participants are required to come to MUMC+ once at inclusion, 6 and 12 months
and at 3 and 9 month a teleconsultation to monitor weight loss progression (0,
3, 6, 9 and 12m). For the first visit, anthropometric data collection, hand
grip strength, blood collection, and FibroScan® with CAPTM will be performed
during the study visit after signing the informed consent. In contrast to the
study visits at inclusion and 12 months, the study visit in month 6 will not
include a blood collection. The other visits will be planned with the
participant. Participants are also asked to fill out different questionnaires.
If the participant is included in the app group than the questionnaires can be
filled out in the app. The participants of the control group can fill out the
questionnaires together with the researcher at the appointments or during the
teleconsultation, or fill out the questionnaires via an online survey.
No side effects of the investigations are expected, apart from a small bruise
of taking the blood samples. Four tubes (15 ml) will be collected for research
purposes.
The time burden associated with participating in the research is: 90 minutes
per study visit. The questionnaires will take around 45 minutes to fill out.
Leading to a total time burden over one year of 5,5 hours.
The participant will benefit through this study on receiving information on how
to lose weight and in the intervention group more intensive monitoring and help
with losing weight. When this weight loss of *5% is achieved, liver steatosis
is expected to be reduced. However not only the risk of NAFLD progression
diminishes, also the risk of developing extra-hepatic complications like
cardiovascular diseases, type 2 diabetes mellitus and extra-hepatic
malignancies.