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

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• Non-alcoholic Fatty Liver Disease 1,507

Non-alcoholic Fatty Liver Disease

1,507 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.

This study's enrollment of 27 is below the median of 60 across 1,098 interventional studies indexed under Non-alcoholic Fatty Liver Disease.

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.

Study arms

• Experimental
  Healthy Liver/Hígado Sano program

  Behavioral: Healthy Liver/Hígado Sano program

• Active comparator
  Control Group

  Behavioral: Usual standard of care

Interventions

• BehavioralHealthy Liver/Hígado Sano program

  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

• BehavioralUsual standard of care

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

Primary outcomes

1. Number of participants recruited

   Time frame: end of study(6 months after enrollment)

2. Number of participants that adhere to the intervention

   Time frame: end of study(6 months after enrollment)

3. Number of participants that complete the study

   Time frame: end of study(6 months after enrollment)

4. 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

   Time frame: end of study(6 months after enrollment)

Secondary outcomes

1. Height of participants

   Time frame: Baseline, 6 months after enrollment

2. Change in weight of participants

   Time frame: Baseline, 6 months after enrollment

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

   Higher levels of ALT indicates liver damage

   Time frame: Baseline, 6 months after enrollment

4. 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

   Time frame: Baseline, 6 months after enrollment

5. 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.

   Time frame: Baseline, 6 months after enrollment

6. 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.

   Time frame: Baseline, 6 months after enrollment

7. 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.

   Time frame: Baseline, 6 months after enrollment

8. 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.

   Time frame: Baseline, 6 months after enrollment

9. 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

   Time frame: Baseline, 6 months after enrollment

10. 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

    Time frame: Baseline, 6 months after enrollment

11. 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)

    Time frame: Baseline, 6 months after enrollment

12. 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.

    Time frame: Baseline, 6 months after enrollment

13. 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.

    Time frame: Baseline, 6 months after enrollment

14. 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 .

    Time frame: Baseline, 6 months after enrollment

15. 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

    Time frame: Baseline, 6 months after enrollment

16. 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.

    Time frame: Baseline, 6 months after enrollment

17. 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

    Time frame: Baseline, 6 months after enrollment

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 ↗

Individual participant data

Plan to share: No