NCT05200585

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

May 11, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2023

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

1.2 years

First QC Date

January 6, 2022

Last Update Submit

October 17, 2023

Conditions

Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (4)

  • Number of participants recruited

    end of study(6 months after enrollment)

  • Number of participants that adhere to the intervention

    end of study(6 months after enrollment)

  • Number of participants that complete the study

    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

    end of study(6 months after enrollment)

Secondary Outcomes (17)

  • Height of participants

    Baseline, 6 months after enrollment

  • Change in weight of participants

    Baseline, 6 months after enrollment

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

    Baseline, 6 months after enrollment

  • Change in liver function as assessed by the Fibrosis-4 (FIB-4) index

    Baseline, 6 months after enrollment

  • Change in physical activity as assessed by the Actigraph GT9X accelerometers

    Baseline, 6 months after enrollment

  • +12 more secondary outcomes

Study Arms (2)

Healthy Liver/Hígado Sano program

EXPERIMENTAL
Behavioral: Healthy Liver/Hígado Sano program

Control Group

ACTIVE COMPARATOR
Behavioral: Usual standard of care

Interventions

Healthy Liver/Hígado Sano programBEHAVIORAL

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

Healthy Liver/Hígado Sano program
Usual standard of careBEHAVIORAL

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

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Does not have a working telephone number

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Natalia I Heredia, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 6, 2022

First Posted

January 20, 2022

Study Start

May 11, 2022

Primary Completion

July 20, 2023

Study Completion

July 20, 2023

Last Updated

October 19, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)