Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 12:08 AM
Study NCT ID:
NCT07456332
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-03-10
First Post:
2025-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect on Body Weight Reduction of a Behavioral Intervention on Lifestyle Using a Digital Nutritional Program in People Living With HIV and Metabolic Dysfunction-associated Steatotic Liver Disease
Sponsor:
Hospital Universitari de Bellvitge
Organization:
Study Overview
Official Title:
Effect on Body Weight Reduction of a Behavioral Intervention on Lifestyle Using a Digital Nutritional Program in People Living With HIV and Metabolic Dysfunction-associated Steatotic Liver Disease
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APEVI
Brief Summary:
Metabolic dysfunction-associated steatotic liver disease (MASLD) is now the leading cause of chronic liver disease in people living with HIV (PLWH). Currently, there are no approved medications to treat this condition. That's why weight loss through healthy lifestyle changes is the most important way to manage it.
This study will test if a digital nutritional program (DNP), using a mobile phone app, can help improve weight loss better than the usual advice on healthy eating and exercise.
The study includes people living with HIV, aged 18 and older, with fatty liver (detected by ultrasound or other scans), and on stable HIV treatment.
Participants will be randomly assigned to two groups:
* Intervention group: Will receive personalized lifestyle support through a mobile app (DNP).
* Control group: Will receive general advice on healthy habits. The study will last 12 months, with follow-up visits during and after the program.
What Will Be Measured:
* Weight, waist size, blood pressure, and body fat.
* Blood tests to check cholesterol, sugar levels, liver enzymes, and other markers.
* Liver scans to assess fat and stiffness.
* Questionnaires on eating habits, exercise, and satisfaction with the program.
Goals of the Study:
Main goal: To see how many people lose at least 5% of their body weight after 6 months.
Other goals: To see the effects on weight after 12 months, and 6 months after stopping the program, and to monitor improvements in liver health.
Why This Matters:
This study aims to find new ways to help people with HIV improve their liver health and overall well-being through simple, practical tools like a mobile app.
This study will test if a digital nutritional program (DNP), using a mobile phone app, can help improve weight loss better than the usual advice on healthy eating and exercise.
The study includes people living with HIV, aged 18 and older, with fatty liver (detected by ultrasound or other scans), and on stable HIV treatment.
Participants will be randomly assigned to two groups:
* Intervention group: Will receive personalized lifestyle support through a mobile app (DNP).
* Control group: Will receive general advice on healthy habits. The study will last 12 months, with follow-up visits during and after the program.
What Will Be Measured:
* Weight, waist size, blood pressure, and body fat.
* Blood tests to check cholesterol, sugar levels, liver enzymes, and other markers.
* Liver scans to assess fat and stiffness.
* Questionnaires on eating habits, exercise, and satisfaction with the program.
Goals of the Study:
Main goal: To see how many people lose at least 5% of their body weight after 6 months.
Other goals: To see the effects on weight after 12 months, and 6 months after stopping the program, and to monitor improvements in liver health.
Why This Matters:
This study aims to find new ways to help people with HIV improve their liver health and overall well-being through simple, practical tools like a mobile app.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: