The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
NCT Number: NCT05200585
The purpose of this study is to pilot test a behavioral lifestyle intervention for Hispanic/Latino patients with non-alcoholic fatty liver disease (NAFLD)
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Houston, Texas, 77030, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The program will last 4-6 months and include 16 sessions, each 30-60 minutes long, that focus on self-management strategies for dietary changes and physical activity and is meant to be delivered in 4-6 months. The 16 sessions are as follows: 1) Introduction to the program, 2) Get Active, 3) Track Your Activity, 4) Eat Well, 5) Track Your Food, 6) Get More Active, 7) Burn More Calories Than You Take In, 8) Shop and Cook, 9) Manage Stress, 10) Find Time for Fitness, 11) Cope with Triggers, 12) Keep Your Heart Healthy, 13) Take Charge of Your Thoughts, 14) Get Support, 15) Eat Well Away from Home, and 16) Staying Motivated
Participants will receive ongoing monitoring of condition at the clinic per standard of care and a short informational pamphlet
Time frame: end of study(6 months after enrollment)
Time frame: end of study(6 months after enrollment)
Time frame: end of study(6 months after enrollment)
Time frame: end of study(6 months after enrollment)
The Client Satisfaction Questionnaire (CSQ) has 8 items.Each one is scored from 1-4, with a total possible score of 32, a higher score indicating greater satisfaction
Time frame: Baseline, 6 months after enrollment
Time frame: Baseline, 6 months after enrollment
Time frame: Baseline, 6 months after enrollment
Higher levels of ALT indicates liver damage
Time frame: Baseline, 6 months after enrollment
The FIB-4 score consists of 4 variables including age,aspartate aminotransferase(AST), ALT, and platelets and evaluates the degree of fibrosis for patients suspected of or already diagnosed with hepatic fibrosis. Participants at low risk of advanced fibrosis have an index of less than 1.3 (age <65 years) or less than 2.0 (age ≥65 years); a score greater than 3.25 is suggestive of advanced fibrosis
Time frame: Baseline, 6 months after enrollment
Moderate-vigorous physical activity counts during the 7-day period will be calculated by summing moderate and vigorous activity counts and then applying a logarithmic transformation to address skew.
Time frame: Baseline, 6 months after enrollment
This is a 27-item self-reported measure of physical activity. The result is reported categorically in one of three categories as follows: Low/inactive - do not meet the criteria for moderate or high activity levels, Moderate - meet 1 of the following: A) 3 or more days with at least 30 minutes of moderate-intensity activity or walking; B) 5 or more days with at least 30 minutes of moderate-intensity activity or walking; C) 5 or more days of any combination of walking, moderate-intensity, or vigorous intensity activities with at least 600 metabolic equivalent of task (MET)-minutes per week. [One MET is energy expenditure when at rest. For instance, 2 METs is twice the energy expended while at rest.] and high - meet 1 of the following: A: 3 or more days of vigorous-intensity activity and at least 1500 MET-minutes per week; B) 7 days of any combination of walking, moderate-intensity or vigorous intensity activities with at least 3000 MET-minutes per week.
Time frame: Baseline, 6 months after enrollment
The School Physical Activity and Nutrition (SPAN) questionnaire is a brief self-administered measure of dietary intake. The healthy foods index will be reported, and total score ranges from 0-50, with a higher score indicating more frequent intake of healthy foods.
Time frame: Baseline, 6 months after enrollment
The School Physical Activity and Nutrition (SPAN) questionnaire is a brief self-administered measure of dietary intake. The unhealthy foods index will be reported, and total score ranges from 0-45, with a higher score indicating more frequent intake of unhealthy foods.
Time frame: Baseline, 6 months after enrollment
alcohol use disorders identification test (AUDITC) is a 3 item measure and will give a general idea of how often participants are drinking alcohol and in what quantities
Time frame: Baseline, 6 months after enrollment
This scale has 13 items, each is scored from 1(none)-5(very often) and 8(does not apply), higher number indicating better social support
Time frame: Baseline, 6 months after enrollment
This scale has 10 items each is scored from 1(none)-5(very often) and 8(does not apply)
Time frame: Baseline, 6 months after enrollment
This is a 9 item questionnaire. The first 8 questions are scored from 0-10 and the 9th question will ask the subject to list in rank-order the three most important factors that they believe caused their illness.
Time frame: Baseline, 6 months after enrollment
Perceived severity will be measured with 2 adapted items that assess to what extent they believe fatty liver disease is a severe health problem and to what extent do they consider complications for fatty liver to be severe health problems. Participants respond on a scale of 1-5, with a higher number indicating a perception that NAFLD is extremely severe.
Time frame: Baseline, 6 months after enrollment
Perceived treatment efficacy will be assessed with 8 items, also adapted from Glasgow et al.that assess the importance of four protective factors (weight loss, eating healthy, avoiding sweets, and physical activity) and the likeliness of those factors to prevent future complications from fatty liver disease. Participants respond on a scale of 1-5, with a higher number indicating higher confidence in NAFLD treatment .
Time frame: Baseline, 6 months after enrollment
Each of the 4 items is scored form (never)-4(very often) with a highest score of 16,indicating more stress
Time frame: Baseline, 6 months after enrollment
This scale consists of 10 questions each one is scored form rarely or none of the time to all of the time.The total score is calculated by finding the sum of 10 items. Any score equal to or above 10 is considered depressed.
Time frame: Baseline, 6 months after enrollment
This scale consists of 7 questions and each is scored form 0(not at all) to 3(nearly every day) for a maximum score of 21, a higher score indicating more anxiety
The University of Texas Health Science Center, Houston
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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