Non-Alcoholic Fatty Liver DiseaseNCT05200585
Pilot of Lifestyle Behavior Intervention for Non-Alcoholic Fatty Liver Disease
A study testing Healthy Liver/Hígado Sano program in people with Non-Alcoholic Fatty Liver Disease, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Healthy Liver/Hígado Sano program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2022to 20 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Does not have a working telephone number
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose of this study is to pilot test a behavioral lifestyle intervention for Hispanic/Latino patients with non-alcoholic fatty liver disease (NAFLD)
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Healthy Liver/Hígado Sano program, Usual standard of care
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Liver/Hígado Sano programBehavioural
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
Usual standard of careBehavioural
Participants will receive ongoing monitoring of condition at the clinic per standard of care and a short informational pamphlet
| Study group | Role | What they receive |
|---|---|---|
| Healthy Liver/Hígado Sano program | Experimental | Not described Receives: Behavioral: Healthy Liver/Hígado Sano program |
| Control Group | Active comparator | Not described Receives: Behavioral: Usual standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants recruited
Measured: end of study(6 months after enrollment)
Number of participants that adhere to the intervention
Measured: end of study(6 months after enrollment)
Number of participants that complete the study
Measured: end of study(6 months after enrollment)
Intervention group participants Satisfaction of program as assessed by the Client Satisfaction Questionnaire (CSQ-8)
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
Measured: end of study(6 months after enrollment)
Secondary outcomes (17)
Height of participants
Measured: Baseline, 6 months after enrollment
Change in weight of participants
Measured: Baseline, 6 months after enrollment
Change in liver function as assessed by alanine aminotransferase (ALT) levels
Higher levels of ALT indicates liver damage
Measured: Baseline, 6 months after enrollment
Change in liver function as assessed by the Fibrosis-4 (FIB-4) index
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
Measured: Baseline, 6 months after enrollment
Change in physical activity as assessed by the Actigraph GT9X accelerometers
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.
Measured: Baseline, 6 months after enrollment
Change in physical activity as assessed by the International Physical Activity Questionnaire
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.
Measured: Baseline, 6 months after enrollment
Change in diet as assessed by the School Physical Activity & Nutrition (SPAN) survey - Healthy foods index
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.
Measured: Baseline, 6 months after enrollment
Change in diet as assessed by the School Physical Activity & Nutrition (SPAN) survey - Unhealthy foods index
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.
Measured: Baseline, 6 months after enrollment
Change in alcohol use as assessed by the alcohol use disorders identification test (AUDITC)
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
Measured: Baseline, 6 months after enrollment
Change in social support for physical activity as assessed by the Social Support for Exercise scales
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
Measured: Baseline, 6 months after enrollment
Change in social support for diet as assessed by the Social Support for Diet scales
This scale has 10 items each is scored from 1(none)-5(very often) and 8(does not apply)
Measured: Baseline, 6 months after enrollment
Change in participant illness perception as assessed by the brief Illness Perception Questionnaire
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.
Measured: Baseline, 6 months after enrollment
Change in perceived severity
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.
Measured: Baseline, 6 months after enrollment
Change in Perceived treatment efficacy
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 .
Measured: Baseline, 6 months after enrollment
Change in Stress as assessed by the 4 items Perceived Stress Scale
Each of the 4 items is scored form (never)-4(very often) with a highest score of 16,indicating more stress
Measured: Baseline, 6 months after enrollment
Change in Depression as assessed by the 10-item Center for Epidemiologic Studies Depression Scale (CESD-10)
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.
Measured: Baseline, 6 months after enrollment
Change in Anxiety as assessed by the 7-item Generalized Anxiety Disorder (GAD-7) questionnaire.
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
Measured: Baseline, 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start11 May 2022
- Primary completion20 Jul 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Prevent Cancer Foundation
- Responsible party
- Principal investigator, Natalia Heredia, The University of Texas Health Science Center, Houston
- Investigators
- Natalia I Heredia, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200585
- Sponsor's protocol ID
- HSC-SPH-21-1008
- Status last verified
- Oct 2023
- First submitted
- 6 Jan 2022
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heredia NI, Hwang JP, Fernandez ME, Lu J, Bauer CX, McNeill LH. Feasibility study of a behavioral lifestyle intervention for Hispanic/Latino patients with metabolic dysfunction-associated steatotic liver disease. BMC Public Health. 2026 Jun 8. doi: 10.1186/s12889-026-27906-z. Online ahead of print.
PubMed 42260444
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot of Lifestyle Behavior Intervention for Non-Alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT05200585
- Acronym / sponsor ID
- HSC-SPH-21-1008
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Prevent Cancer Foundation
- Study start
- 11 May 2022 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to pilot test a behavioral lifestyle intervention for Hispanic/Latino patients with non-alcoholic fatty liver disease (NAFLD)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Liver/Hígado Sano program | Experimental | Behavioral: Healthy Liver/Hígado Sano program |
| Control Group | Active comparator | Behavioral: Usual standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Does not have a working telephone number
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Liver/Hígado Sano programThe 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 | Behavioural | Healthy Liver/Hígado Sano program |
| Usual standard of careParticipants will receive ongoing monitoring of condition at the clinic per standard of care and a short informational pamphlet | Behavioural | Control Group |
Primary outcome
Number of participants recruited
Time frame: end of study(6 months after enrollment)
Number of participants that adhere to the intervention
Time frame: end of study(6 months after enrollment)
Number of participants that complete the study
Time frame: end of study(6 months after enrollment)
Intervention group participants Satisfaction of program as assessed by the Client Satisfaction Questionnaire (CSQ-8)
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
17 secondary outcomes
Height of participants
Time frame: Baseline, 6 months after enrollment
Change in weight of participants
Time frame: Baseline, 6 months after enrollment
Change in liver function as assessed by alanine aminotransferase (ALT) levels
Time frame: Baseline, 6 months after enrollment
Change in liver function as assessed by the Fibrosis-4 (FIB-4) index
Time frame: Baseline, 6 months after enrollment
Change in physical activity as assessed by the Actigraph GT9X accelerometers
Time frame: Baseline, 6 months after enrollment
Change in physical activity as assessed by the International Physical Activity Questionnaire
Time frame: Baseline, 6 months after enrollment
Change in diet as assessed by the School Physical Activity & Nutrition (SPAN) survey - Healthy foods index
Time frame: Baseline, 6 months after enrollment
Change in diet as assessed by the School Physical Activity & Nutrition (SPAN) survey - Unhealthy foods index
Time frame: Baseline, 6 months after enrollment
Change in alcohol use as assessed by the alcohol use disorders identification test (AUDITC)
Time frame: Baseline, 6 months after enrollment
Change in social support for physical activity as assessed by the Social Support for Exercise scales
Time frame: Baseline, 6 months after enrollment
Change in social support for diet as assessed by the Social Support for Diet scales
Time frame: Baseline, 6 months after enrollment
Change in participant illness perception as assessed by the brief Illness Perception Questionnaire
Time frame: Baseline, 6 months after enrollment
Change in perceived severity
Time frame: Baseline, 6 months after enrollment
Change in Perceived treatment efficacy
Time frame: Baseline, 6 months after enrollment
Change in Stress as assessed by the 4 items Perceived Stress Scale
Time frame: Baseline, 6 months after enrollment
Change in Depression as assessed by the 10-item Center for Epidemiologic Studies Depression Scale (CESD-10)
Time frame: Baseline, 6 months after enrollment
Change in Anxiety as assessed by the 7-item Generalized Anxiety Disorder (GAD-7) questionnaire.
Time frame: Baseline, 6 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Derived from this study: PubMed 42260444Heredia NI, Hwang JP, Fernandez ME, Lu J, Bauer CX, McNeill LH. Feasibility study of a behavioral lifestyle intervention for Hispanic/Latino patients with metabolic dysfunction-associated steatotic liver disease. BMC Public Health. 2026 Jun 8. doi: 10.1186/s12889-026-27906-z. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalia I Heredia, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Liver/Hígado Sano program in people with Non-Alcoholic Fatty Liver Disease, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants recruited (time frame: end of study(6 months after enrollment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05200585, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.