Metabolic-dysfunction Associated Liver Disease (MASLD)
Conditions
Keywords
weight loss, alcohol consumption, Diabetes Prevention Program (DPP)
Brief summary
The purpose of this study is to understand if a behavioral lifestyle intervention called the Healthy Liver/Hígado Sano program can help Hispanic/Latino patients with metabolic dysfunction associated steatotic liver disease (MASLD), also known as non-alcoholic fatty liver disease (NAFLD), lose weight and improve their liver health
Detailed description
This feasibility study will use a quasi-experimental design to test an adapted multilevel intervention with Hispanic/Latino adults with metabolic dysfunction-associated steatotic liver disease at an intervention clinic, compared to similar participants at an observational clinic receiving usual care. The investigators will collect and analyze quantitative and qualitative data, specifically, clinical/biometric, anthropometric, behavioral, and psychosocial assessments at baseline, 6, and 12 months at the individual level, and additionally collect data from family members, providers/staff, and community health workers/social workers. At the end of the study, the investigators will also conduct in-depth interviews to contextualize quantitative results and gain deeper insights into intervention experiences.
Interventions
BEHAVIORALHealthy Liver/Hígado Sano program
Participants will attend 16 educational classes over a 6-month period. These sessions are facilitated by a lifestyle coach in a group setting and last about an hour. Family members attend the sessions with the participant. Additionally, providers and staff at the clinic receive training on MASLD background information, including MASLD management, and motivational interviewing. Clinic community health workers and/or social workers assess participants for unmet social needs and refer as appropriate to social services.
BEHAVIORALUsual Care
Observational clinic participants receive usual care, which can include referrals to dieticians and/or specialists.
Sponsors
The University of Texas Health Science Center, Houston
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Self-reported Hispanic/Latino * Have been diagnosed with MASLD * Be an adult \>= 18 years of age * Able to speak English or Spanish * Have a working telephone number * Have access to internet, either on their phone, at home or at some other location convenient to the participant * Have a family member willing to attend all sessions
Exclusion criteria
* Taking a GLP-1 receptor agonist or dual agonist at the time of enrollment, or plans to being taking one in the next 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Feasibility | Baseline | Recruitment will be assessed to be feasible if ≥65% of eligible participants enroll in the study |
| Retention | 6 months, 12 months | Percent of participants who complete follow-up data collection |
| Adherence | 6 months | Intervention participants who attend education sessions |
| Participant satisfaction | 6 months | The Client Satisfaction Questionnaire (CSQ-8) is an 8-item self-report instrument assessing satisfaction with services received. Each item is rated on a 4-point Likert scale (1 = least satisfied, 4 = most satisfied). Item scores are summed to produce a total score ranging from 8 to 32, with higher scores indicating greater satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Physical Activity | Baseline, 6 months, 12 months | The International Physical Activity Questionnaire(IPAQ) is a 27-item questionnaire assessing the frequency (days per week) and duration (minutes per day) of physical activities across four domains: work, transportation, household/gardening, and leisure-time, as well as time spent sitting. Physical activity scores are calculated in metabolic equivalent task minutes per week (MET-minutes/week) by multiplying activity intensity (Walking = 3.3 METs, Moderate = 4.0 METs, Vigorous = 8.0 METs) × duration × frequency within each domain. Total physical activity is obtained by summing across all domains, and respondents are classified into Low, Moderate, or High activity categories according to standardized IPAQ scoring guidelines. |
| Accelerometer-assessed physical activity | Baseline, 6 months, 12 months | As assessed by the Actigraph GT9X accelerometers |
| Diet | Baseline, 6 months, 12 months | The National Cancer Institute's Family Life, Activity, Sun, Health, and Eating (FLASHE) dietary screener self reported questionnaire s a 27-item questionnaire that captures past 7-day consumption of fast and junk foods, sugary foods/desserts, fruits and vegetables, and sugar-sweetened beverages. Each item is scored based on reported frequency (ranging from "Never" to "2 or more times per day"). For each food category, responses are converted to frequency per day. Higher frequencies indicate greater reported intake of that food category |
| Weight | Baseline, 6 months, 12 months | Staff-assessed using Tanita scale |
| Liver steatosis and/or stiffness | Baseline, 6 months, 12 months | Liver steatosis and/or stiffness as assessed by FibroScan and/or potential steatosis as assessed by liver enzymes using Piccolo Xpress chemistry analyzer |
| Fasting glucose levels | Baseline, 6 months, 12 months | As assessed using Piccolo Xpress chemistry analyzer |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNatalia Heredia
The University of Texas Health Science Center, Houston
Outcome results
None listed