Prevention of NAFLD in Hispanic Children

NCT ID: NCT05292352

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-06
• Study Completion Date: 2027-01-31

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.

Detailed Description

The number of children experiencing obesity and the chronic diseases associated with it have risen dramatically in recent decades. This includes non-alcoholic fatty liver disease (NAFLD). NAFLD is an excess accumulation of fat in the liver that results when children's diet and activity patterns compound the genetic risk with which they were born. Excess fat in the liver increases the risk of diabetes and heart disease as well the chance that a liver transplant will be needed. Previous studies suggest that diets high in sugar, particularly during critical periods of development, increases children's risk of developing NAFLD. The study team has previously shown that reducing intake of free sugars (those used to sweeten foods and beverages and those found naturally in fruit juices) to very low levels, reduces the amount of fat stored in the liver and improves the metabolic health of children with NAFLD.

This single site randomized clinical trial is designed to determine if following a diet very low in free sugars just before puberty, a time of increased metabolic disruption, can help to prevent NAFLD in children known to be at high risk. This trial will study free-living Hispanic children with overweight or obesity because their increase in risk for NAFLD compared to non-Hispanic children has been well documented. Enrollment will include children age 6-9 years and Tanner stage 1 living in the Atlanta metropolitan area. Recruitment is through local pediatric clinics and through parents attending diabetes and NAFLD clinics. Enrollment and informed consent is performed by members of the research team. The one-year dietary intervention, will include a combination of evidence-based strategies: dietary counseling by a nutritionist using motivational interviewing and family-centered goal setting; a one-month provision of a low-free sugar diet for the entire family, and nutritionist guided (and study funded) grocery shopping trips every 3 months thereafter. The control group will follow their usual diet and receive similar study assessments, and compensation.

The primary outcome at year one is MRI-assessed change in the amount of liver fat from baseline. At 24 months, incidence of NAFLD in the intervention group vs. control group will be assessed (primary outcome of 24 month study). Other outcomes to be assessed at 12- and 24-months include changes in liver enzymes, glucose metabolism, dyslipidemia, body composition and metabolomics.

These studies may inform the development of guidelines for clinicians, dietitians, parents, and others involved in counseling and caring for children at high risk of developing NAFLD.

Conditions

Non-Alcoholic Fatty Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Low Free Sugar Diet (LFSD) Intervention

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.

Group Type: EXPERIMENTAL

LFSD

Intervention Type: 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.

Usual Care Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

LFSD

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. At least one parent or the child self-identifies as Hispanic or Latino.

2. BMI ≥ 50th percentile for age and sex.

3. Age ≥ 6 years and ≤ 9 years

4. Tanner stage 1 by self and/or parental report

5. Normal ALT on screening labs (≤23 IU for girls, ≤26 IU for boys)

6. Written informed consent from parent or legal guardian, assent from child

Exclusion Criteria

1. Known diagnosis of chronic liver disease other than NAFLD and "fatty liver"

2. History of significant depression

3. Implanted metal or other implant (braces ok), or claustrophobia or other reason that contraindicates MRI

4. Type 2 diabetes (Hemoglobin A1c > 6.4% on screening labs or chronic diagnosis)

5. Plans to move within the next 12 months

6. Current or previous participation in a weight loss program or obesity treatment program or clinic

7. Cancer or history of cancer

8. Recipient of a liver transplant

9. Chronic use (in the last year) of medications known to cause NAFLD or fatty liver (TPN, amiodarone, chronic oral steroids, etc.)

10. Intellectual disability or major psychiatric disorder limiting informed assent

11. At risk for eating disorder by screening instrument

12. Participants who are currently enrolled in a clinical trial or have received an investigational product within the last 60 days

13. 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

14. Children who spend more than 1 night per week consistently in another household

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Miriam Vos

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miriam Vos, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University

Atlanta, Georgia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37019180 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01NR019083-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2025P010571

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY00002076

Identifier Type: -

Identifier Source: org_study_id