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

NCT ID: NCT05200585

Last Updated: 2023-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-11

Study Completion Date

2023-07-20

Brief Summary

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The purpose of this study is to pilot test a behavioral lifestyle intervention for Hispanic/Latino patients with non-alcoholic fatty liver disease (NAFLD)

Detailed Description

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Conditions

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Non-Alcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Healthy Liver/Hígado Sano program

Group Type EXPERIMENTAL

Healthy Liver/Hígado Sano program

Intervention Type BEHAVIORAL

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

Control Group

Group Type ACTIVE_COMPARATOR

Usual standard of care

Intervention Type BEHAVIORAL

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

Interventions

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Healthy 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

Intervention Type BEHAVIORAL

Usual standard of care

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prevent Cancer Foundation

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Natalia Heredia

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Natalia I Heredia, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC-SPH-21-1008

Identifier Type: -

Identifier Source: org_study_id

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