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| ID | Type | Description | Link |
|---|---|---|---|
| K01MD019149 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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The purpose of this study is to understand if a behavioral lifestyle intervention called the Healthy Liver/HÃgado 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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Liver/HÃgado Sano program | Experimental |
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| Usual Care | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy Liver/HÃgado Sano program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Feasibility | Recruitment will be assessed to be feasible if ≥65% of eligible participants enroll in the study | Baseline |
| Retention | Percent of participants who complete follow-up data collection | 6 months, 12 months |
| Adherence | Intervention participants who attend education sessions | 6 months |
| Participant satisfaction | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported Physical Activity | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natalia Heredia | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| Usual Care | Behavioral | Observational clinic participants receive usual care, which can include referrals to dieticians and/or specialists. |
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| Baseline, 6 months, 12 months |
| Accelerometer-assessed physical activity | As assessed by the Actigraph GT9X accelerometers | Baseline, 6 months, 12 months |
| Diet | 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 | Baseline, 6 months, 12 months |
| Weight | Staff-assessed using Tanita scale | Baseline, 6 months, 12 months |
| Liver steatosis and/or stiffness | Liver steatosis and/or stiffness as assessed by FibroScan and/or potential steatosis as assessed by liver enzymes using Piccolo Xpress chemistry analyzer | Baseline, 6 months, 12 months |
| Fasting glucose levels | As assessed using Piccolo Xpress chemistry analyzer | Baseline, 6 months, 12 months |
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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