"CAP" Fetge Gras. Lifestyle Modification Program in Catalonia.

NCT04988633 | Completed

• 1 other identifier: CFG
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to investigate whether an online lifestyle modification program for people with Metabolic Associated Fatty Liver Disease (MAFLD) through a mobile application produces a significant reduction in liver steatosis and is associated with a higher rate of weight loss compared to standard recommendations currently indicated in Primary Care.

Conditions

Non-Alcoholic Fatty Liver Disease; Liver Diseases; Lifestyle, Healthy

Outcome Measures

Primary Outcomes (1)

• Rate of reduction in hepatic steatosis in people with MAFLD.

  Month 12

Secondary Outcomes (10)

• Liver steatosis improvement rate according to CAP value (dB/m)

  Month 6 and 12

• Changes from baseline in weight (kg) at month 6 and month 12.

  Month 6 and 12

• Changes from baseline in abdominal circumference (cm) and anthropometric variables at month 6 and 12.

  Month 6 and 12

• Adherence to healthy lifestyle with

  Month 6 and 12

• Changes from baseline in cardiovascular risk through REGICOR at month 6 and 12.

  Month 6 and 12

Study Arms (2)

Intervention CFG App

EXPERIMENTAL

Online healthy lifestyle education through an App. The intervention will consist of viewing educational videos on diet and exercise through an App.

Behavioral: Intervention CFG App

Control Group

EXPERIMENTAL

Standard tips for healthy lifestyles that are carried out in regular Primary Care practice.

Behavioral: Control Group

Interventions

Intervention CFG App BEHAVIORAL

Online healthy lifestyle education through an App. The intervention will consist of viewing educational videos on diet and exercise through an App. Videos will be uploaded to the app on a weekly basis, lasting 2-3.

Intervention CFG App

Control Group BEHAVIORAL

Standard tips for healthy lifestyles that are carried out in regular Primary Care practice. After day 1, where standard advice is received, follow-up visits are conducted at week 2, week 4, month 3, and month 6.

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Fibroscan® with a CAP ≥ 300 dB/m and liver stiffness \<8 Kpa.

You may not qualify if:

• Serious chronic disease (heart, respiratory, cancer, etc.).
• Chronic liver disease.
• Chronic kidney disease (FGR \<60ml/min).
• Weight loss\> 5% during the last three months.
• AUDIT- C\> 8
• Impossibility to follow the recommended diet (for religious reasons, swallowing problems, etc.) or inability to perform physical activity.
• Inability to follow the scheduled visits to the intervention (institutionalized individuals, lack of autonomy, inability to walk, lack of a stable home, travel plans, etc.).
• Have been included in another weight loss advice program (\>5 kg) during the 6 months prior to the selection visit (basal visit).
• History of having followed a low calorie diet (\<900Kcal/day) for the last 6 months.
• History of surgical procedures to lose weight or intend to undergo bariatric surgery in the next 12 months.
• Hemoglobin A1c ≥ 9%.
• History of resection of the small or large intestine.
• History of inflammatory bowel disease.
• BMI\> 40 or obesity of known endocrine origin (with the exception of treated hypothyroidism).
• Current treatment with systemic corticosteroids.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• University of Barcelona: collaborator
• Institut d'Investigacions Biomèdiques August Pi i Sunyer: collaborator

Study Sites (1)

Núria Fabrellas

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Diseases

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Fatty Liver; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase III, single-centre, randomized clinical trial

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 3, 2021
• Study Start: May 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 31, 2022
• Last Updated: January 23, 2024

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)