"CAP" Fetge Gras. Lifestyle Modification Program in Catalonia. (NCT04988633) | Clinical Trial Compass
CompletedNot Applicable
"CAP" Fetge Gras. Lifestyle Modification Program in Catalonia.
Spain90 participantsStarted 2021-05-01
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Age ≥ 18 years old
* Fibroscan® with a CAP ≥ 300 dB/m and liver stiffness \<8 Kpa.
Exclusion Criteria:
* 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.
* Current use of medication for weight loss.
* Current treatment with steatogenic drugs.
* People participating in a clinical trial with drugs.
* Patients with mental incapacity, language barrier, bad social support or any other reason considered by the investigato…
What they're measuring
1
Rate of reduction in hepatic steatosis in people with MAFLD.