Pilot of Lifestyle Behavior Intervention for Non-Alcoholic Fatty Liver Disease

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Healthy Liver/Hígado Sano program

Usual standard of care

About this trial

This is an interventional prevention trial for Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Healthy Liver/Hígado Sano program

Control Group

Arm Description

Outcomes

Primary Outcome Measures

Number of participants recruited

Number of participants that adhere to the intervention

Number of participants that complete the study

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

Secondary Outcome Measures

Height of participants

Change in weight of participants

Change in liver function as assessed by alanine aminotransferase (ALT) levels

Higher levels of ALT indicates liver damage

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

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.

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.

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.

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.

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

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

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)

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.

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.

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 .

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

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.

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

Full Information

NCT ID

NCT05200585

First Posted

January 6, 2022

Last Updated

October 17, 2023

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

Prevent Cancer Foundation

1. Study Identification

Unique Protocol Identification Number

NCT05200585

Brief Title

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

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

May 11, 2022 (Actual)

Primary Completion Date

July 20, 2023 (Actual)

Study Completion Date

July 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

Collaborators

Prevent Cancer Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Alcoholic Fatty Liver Disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Healthy Liver/Hígado Sano program

Arm Type

Experimental

Arm Title

Control Group

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

Healthy Liver/Hígado Sano program

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Usual standard of care

Intervention Description

Participants will receive ongoing monitoring of condition at the clinic per standard of care and a short informational pamphlet

Primary Outcome Measure Information:

Title

Number of participants recruited

Time Frame

end of study(6 months after enrollment)

Title

Number of participants that adhere to the intervention

Time Frame

end of study(6 months after enrollment)

Title

Number of participants that complete the study

Time Frame

end of study(6 months after enrollment)

Title

Intervention group participants Satisfaction of program as assessed by the Client Satisfaction Questionnaire (CSQ-8)

Description

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

end of study(6 months after enrollment)

Secondary Outcome Measure Information:

Title

Height of participants

Time Frame