Clinical trial NCT05200585: Pilot of Lifestyle Behavior Intervention for Non-Alcoholic Fatty Liver Disease
Official title: Pilot of Lifestyle Behavior Intervention for Non-Alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Prevent Cancer Foundation
First posted: 2022-01-20
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to pilot test a behavioral lifestyle intervention for Hispanic/Latino patients with non-alcoholic fatty liver disease (NAFLD)


Eligibility criteria: Inclusion Criteria:

* Self-reported Hispanic/Latino
* Have been diagnosed with NAFLD
* Able to speak English or Spanish
* Have access to internet, either on their phone, at home or at some other location convenient to the participant

Exclusion Criteria:

* Does not have a working telephone number

Primary outcomes:
measure: Number of participants recruited
timeFrame: end of study(6 months after enrollment)
measure: Number of participants that adhere to the intervention
timeFrame: end of study(6 months after enrollment)
measure: Number of participants that complete the study
timeFrame: end of study(6 months after enrollment)
measure: Intervention group participants Satisfaction of program as assessed by the Client Satisfaction Questionnaire (CSQ-8)
timeFrame: end of study(6 months after enrollment)
Secondary outcomes:
measure: Height of participants
timeFrame: Baseline, 6 months after enrollment
measure: Change in weight of participants
timeFrame: Baseline, 6 months after enrollment
measure: Change in liver function as assessed by alanine aminotransferase (ALT) levels
timeFrame: Baseline, 6 months after enrollment
measure: Change in liver function as assessed by the Fibrosis-4 (FIB-4) index
timeFrame: Baseline, 6 months after enrollment
measure: Change in physical activity as assessed by the Actigraph GT9X accelerometers
timeFrame: Baseline, 6 months after enrollment
measure: Change in physical activity as assessed by the International Physical Activity Questionnaire
timeFrame: Baseline, 6 months after enrollment
measure: Change in diet as assessed by the School Physical Activity & Nutrition (SPAN) survey - Healthy foods index
timeFrame: Baseline, 6 months after enrollment
measure: Change in diet as assessed by the School Physical Activity & Nutrition (SPAN) survey - Unhealthy foods index
timeFrame: Baseline, 6 months after enrollment
measure: Change in alcohol use as assessed by the alcohol use disorders identification test (AUDITC)
timeFrame: Baseline, 6 months after enrollment
measure: Change in social support for physical activity as assessed by the Social Support for Exercise scales
timeFrame: Baseline, 6 months after enrollment
measure: Change in social support for diet as assessed by the Social Support for Diet scales
timeFrame: Baseline, 6 months after enrollment
measure: Change in participant illness perception as assessed by the brief Illness Perception Questionnaire
timeFrame: Baseline, 6 months after enrollment
measure: Change in perceived severity
timeFrame: Baseline, 6 months after enrollment
measure: Change in Perceived treatment efficacy
timeFrame: Baseline, 6 months after enrollment
measure: Change in Stress as assessed by the 4 items Perceived Stress Scale
timeFrame: Baseline, 6 months after enrollment
measure: Change in Depression as assessed by the 10-item Center for Epidemiologic Studies Depression Scale (CESD-10)
timeFrame: Baseline, 6 months after enrollment
measure: Change in Anxiety as assessed by the 7-item Generalized Anxiety Disorder (GAD-7) questionnaire.
timeFrame: Baseline, 6 months after enrollment
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Natalia I Heredia, PhD
role: PRINCIPAL_INVESTIGATOR
References: