RESUMO
BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) has become the most common chronic liver disease in the world. Common comorbidities are central obesity, type 2 diabetes mellitus, dyslipidemia, and metabolic syndrome. Cardiovascular disease is the most common cause of death among people with NAFLD, and lifestyle changes can improve health outcomes. OBJECTIVE: This study aims to explore the acceptability of a digital health program in terms of engagement, retention, and user satisfaction in addition to exploring changes in clinical outcomes, such as weight, cardiometabolic risk factors, and health-related quality of life. METHODS: We conducted a prospective, open-label, single-arm, 12-week study including 38 individuals with either a BMI >30, metabolic syndrome, or type 2 diabetes mellitus and NAFLD screened by FibroScan. An NAFLD-specific digital health program focused on disease education, lowering carbohydrates in the diet, food logging, increasing activity level, reducing stress, and healthy lifestyle coaching was offered to participants. The coach provided weekly feedback on food logs and other in-app activities and opportunities for participants to ask questions. The coaching was active throughout the 12-week intervention period. The primary outcome was feasibility and acceptability of the 12-week program, assessed through patient engagement, retention, and satisfaction with the program. Secondary outcomes included changes in weight, liver fat, body composition, and other cardiometabolic clinical parameters at baseline and 12 weeks. RESULTS: In total, 38 individuals were included in the study (median age 59.5, IQR 46.3-68.8 years; n=23, 61% female). Overall, 34 (89%) participants completed the program and 29 (76%) were active during the 12-week program period. The median satisfaction score was 6.3 (IQR 5.8-6.7) of 7. Mean weight loss was 3.5 (SD 3.7) kg (P<.001) or 3.2% (SD 3.4%), with a 2.2 (SD 2.7) kg reduction in fat mass (P<.001). Relative liver fat reduction was 19.4% (SD 23.9%). Systolic blood pressure was reduced by 6.0 (SD 13.5) mmHg (P=.009). The median reduction was 0.14 (IQR 0-0.47) mmol/L for triglyceride levels (P=.003), 3.2 (IQR 0.0-5.4) µU/ml for serum insulin (s-insulin) levels (P=.003), and 0.5 (IQR -0.7 to 3.8) mmol/mol for hemoglobin A1c (HbA1c) levels (P=.03). Participants who were highly engaged (ie, who used the app at least 5 days per week) had greater weight loss and liver fat reduction. CONCLUSIONS: The 12-week-long digital health program was feasible for individuals with NAFLD, receiving high user engagement, retention, and satisfaction. Improved liver-specific and cardiometabolic health was observed, and more engaged participants showed greater improvements. This digital health program could provide a new tool to improve health outcomes in people with NAFLD. TRIAL REGISTRATION: Clinicaltrials.gov NCT05426382; https://clinicaltrials.gov/study/NCT05426382.
RESUMO
Hospital-based supervised exercise (SEP) is a guideline-recommended intervention for patients with intermittent claudication (IC). However, due to the limited availability of SEP, home-based structured exercise programs (HSEP) have become increasingly popular alongside the "go home and walk" advice. We evaluated the cost-effectiveness of walk advice (WA) with Nordic pole walking vs. SEP combined with WA or HSEP combined with WA. We used data from the SUNFIT RCT (NCT02341716) to measure quality-adjusted life-years (QALYs) over a 12-month follow-up, and economic costs were obtained from a hospital cost-per-patient accounting system. Incremental cost-effectiveness ratios (ICERs) were calculated, and uncertainty was assessed using nonparametric bootstrapping. The average health-care-cost per patient was similar in the WA (EUR 1781, n = 51) and HSEP (EUR 1820, n = 48) groups but higher in the SEP group (EUR 4619, n = 50, p-value < 0.01). Mean QALYs per patient during the follow-up were similar with no statistically significant differences. The findings do not support SEP as a cost-effective treatment for IC, as it incurred significantly higher costs without providing additional health improvements over WA with or without HSEP during the one-year observation period. The analysis also suggested that HSEP may be cost-effective compared to WA, but only with a 64% probability.