Feasibility study of a behavioral lifestyle intervention for Hispanic/Latino patients with metabolic dysfunction-associated steatotic liver disease.

INTRODUCTION

Metabolic dysfunction-associated steatotic liver disease (MASLD) can lead to longer-term adverse health outcomes if left unmanaged, including liver failure and liver cancer. Hispanic adults have the highest rates of MASLD of any U.S. racial/ethnic subgroup. The most effective treatment is weight loss, through healthy dietary changes and increased physical activity. This study conducted 2022-2023 aimed to assess the feasibility and acceptability (primary), as well as exploratory effectiveness outcomes, of a behavioral lifestyle intervention for Hispanic patients with MASLD.

METHODS

Participants were recruited from a federally qualified health center. Self-administered questionnaires assessed demographic, psychosocial and behavioral variables. Staff measured height and weight. Individuals were randomized into intervention or wait-list control groups. The intervention, Healthy Liver/Hígado Sano, is adapted from the Diabetes Prevention Program and involves 16 weekly, group-delivered sessions. We assessed feasibility and acceptability of delivering the program in partnership with a clinic, as well as summary statistics at baseline and follow-up. We calculated between-group differences in change between the two groups for exploratory effectiveness outcomes using two-sample t-tests and chi-square tests, as appropriate.

RESULTS

Of the 60 individuals screened, 45 were eligible (75%). Of these, 33 consented (73%) and 27 completed baseline data collection (60%) and were randomized, 13 to the wait-list control (usual care) and 14 to intervention condition. At follow-up, 19 of the 27 randomized (70%) were retained. Average age was 48.5 and 46.6 years in control and intervention groups, respectively. Most were female (84.6% control, 85.7% intervention) and had low acculturation (92-93%). Median satisfaction was 26 (of potential range 8-32), suggesting moderate acceptability among participants who completed follow-up. For exploratory effectiveness outcomes, while not statistically significant, intervention participants showed greater improvements in MASLD illness perception, treatment efficacy, social support, healthy eating index, and walking MET-minutes as compared to the control group.

CONCLUSIONS

Recruitment was feasible and participants found the intervention acceptable, though improvements are needed for retention. Findings will inform future trial implementation and refinement.

TRIAL REGISTRATION: This study was registered at clinicaltrials.gov (NCT05200585) on January 6, 2022.