Prevention of NAFLD in Hispanic Children

NCT05292352 | Active Not Recruiting DMC

• 3 other identifiers: STUDY000020761R01NR019083-01A12025P010571
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 2 year clinical trial testing an intensive intervention to reduce dietary sugars as a means to prevent non-alcoholic fatty liver disease (NAFLD) in pre-pubertal Hispanic children.

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

Latino Children; Pre-puberal; Low Free sugar diet (LFSD)

Outcome Measures

Primary Outcomes (2)

• Change in Percent Hepatic Steatosis by MRI-PDFF

  The primary objective for the 12-month study is to test if an LFSD, compared to usual diet protects against increase in hepatic steatosis

  12 month after start of intervention

• Onset of NAFLD

  The primary objective for the 24-month is to study to test if an LFSD protects against development of NAFLD (hepatic steatosis ≥ 5% and elevated ALT).

  24 months after start of intervention

Secondary Outcomes (12)

• Changes in markers of liver inflammation: ALT

  Baseline, month 6, month 12, month 18, and month 24

• Changes in markers of liver inflammation: AST

  Baseline, month 6, month 12, month 18, and month 24

• Changes in markers of liver inflammation: GGT

  Baseline, month 12 and month 24

• Changes in HbA1c

  Baseline, month 12 and month 24

• Changes in fasting triglycerides

  Baseline, Month 6, Month 12, month 18 and month 24

Study Arms (2)

Low Free Sugar Diet (LFSD) Intervention

EXPERIMENTAL

The 1-year dietary intervention will be accomplished by adapting and extending a Social Cognitive Theory (SCT) guided low sugar intervention. SCT is a framework that helps explain how people regulate their behavior through control and reinforcement to achieve goal-directed behavior that can be maintained over time.

Behavioral: LFSD

Usual Care Control

NO INTERVENTION

Usual Care (Control group): Parents of enrolled children in the usual care group will be provided printed material on healthy family lifestyle at the beginning of the study. The control group will complete all of the same research visits and assessments as the intervention group.

Interventions

LFSD BEHAVIORAL

Assessment of child's usual diet to assess sugar intake in relation to the total usual diet. Consultation with a nutritionist to help families identify foods high in sugar. Removal of foods and drinks high in free sugar from the home. Counseling using motivational interviewing, patient-centered goal setting to help parents and participating youth identify barriers to compliance with the intervention. Provision of a study provided LFSD with sufficient quantity to meet the needs and adapted to meet the preferences of the entire household for the first 4 weeks. Facilitated grocery shopping trips every 3 months during year 1.

Low Free Sugar Diet (LFSD) Intervention

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• At least one parent or the child self-identifies as Hispanic or Latino.
• BMI ≥ 50th percentile for age and sex.
• Age ≥ 6 years and ≤ 9 years
• Tanner stage 1 by self and/or parental report
• Normal ALT on screening labs (≤23 IU for girls, ≤26 IU for boys)
• Written informed consent from parent or legal guardian, assent from child

You may not qualify if:

• Known diagnosis of chronic liver disease other than NAFLD and "fatty liver"
• History of significant depression
• Implanted metal or other implant (braces ok), or claustrophobia or other reason that contraindicates MRI
• Type 2 diabetes (Hemoglobin A1c \> 6.4% on screening labs or chronic diagnosis)
• Plans to move within the next 12 months
• Current or previous participation in a weight loss program or obesity treatment program or clinic
• Cancer or history of cancer
• Recipient of a liver transplant
• Chronic use (in the last year) of medications known to cause NAFLD or fatty liver (TPN, amiodarone, chronic oral steroids, etc.)
• Intellectual disability or major psychiatric disorder limiting informed assent
• At risk for eating disorder by screening instrument
• Participants who are currently enrolled in a clinical trial or have received an investigational product within the last 60 days
• Participants who are not able or willing to comply with the diet protocol or have any other condition or circumstance that would impede compliance or hinder completion of the study in the opinion of the investigator
• Children who spend more than 1 night per week consistently in another household

Sponsors & Collaborators

• Emory University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30329, United States

Location

Related Publications (1)

• Welsh JA, Pyo E, Huneault H, Gonzalez Ramirez L, Alazraki A, Alli R, Dunbar SB, Khanna G, Knight-Scott J, Pimentel A, Reed B, Rodney-Somersall C, Santoro N, Umpierrez G, Vos MB. Study protocol for a randomized, controlled trial using a novel, family-centered diet treatment to prevent nonalcoholic fatty liver disease in Hispanic children. Contemp Clin Trials. 2023 Jun;129:107170. doi: 10.1016/j.cct.2023.107170. Epub 2023 Apr 3.

  PMID: 37019180 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Jean Welsh, PhD, MPH, RN

  Emory University

  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: Associate Professor

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 23, 2022
• Study Start: April 6, 2022
• Primary Completion: March 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be made available 6 months after publication. Applications must be submitted within 24 months of publication date.
• Access Criteria: Researchers who provide a methodologically sound proposal, to achieve aims in an approved proposal. Access will be granted by submitting written detailed proposal to the corresponding author of the published article.

Locations

US (1)