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

Conditions
fatty liver
non-alcoholic fatty liver disease
10019654
10003018
Registration Number
NL-OMON52163
Lead Sponsor
niversiteit Maastricht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
200
Inclusion Criteria

• Aged 18 years or older
• Diagnosed with NAFLD by CAPTM (>215 dB/m) as measured by the FibroScan®
device and VCTE <=7.2 kPa for the XL probe or <=7.9 kPa for the M-probe
• Able to give informed consent in Dutch
• Able to understand the information sheet and willing to comply with the study
protocol
• For the mobile app: a smartphone with a software version of at least iOS 13
or Android 7.0 Nougat

Exclusion Criteria

• Not proficient in the Dutch language
• Already in a weight-loss/management project included (e.g., weight watchers,
dietitian guidance).

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Main study parameter/endpoint: a *5% reduction in weight measured in kg. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary study parameters/endpoints:<br /><br>1) Reduction of NAFLD (as measured by the FibroScan®).<br /><br>2) Acceptability and satisfaction of the Happi liver mobile application.<br /><br>3) An increase in knowledge concerning NAFLD.<br /><br>4) Quality of life improvement.</p><br>
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