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Prevention of Pediatric NAFLD in Hispanic Children

Award Number: R01NR019083
ORGANIZATION: NATIONAL INSTITUTE OF NURSING RESEARCH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/05/2021
PERIOD OF PERFORMANCE END DATE: 01/31/2026

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Prevention of Pediatric NAFLD in Hispanic Children - Abstract Nonalcoholic fatty liver disease (NAFLD) is an obesity-associated liver disease that affects an estimated 7 million children in the United States. It is the most common reason for liver transplantation in adults and increases long term risk of diabetes and cardiovascular disease. NAFLD disproportionately affects Hispanic children and is an exceptionally important health disparity. The proposed studies will address prevention of NAFLD in children because current treatments are only partially effective, and no cure exists for the disease. A unique physiologic opportunity exists in children in that NAFLD appears to have a narrow time of onset in children, during early puberty. In a recently completed randomized clinical diet provision trial comparing a very low free sugar diet to usual care, we demonstrated improved hepatic steatosis, liver inflammation and rate of de novo lipogenesis in children who already have NAFLD. However, it is unknown if providing a low free sugar diet (LFSD) in pre-pubertal children can help prevent hepatic steatosis and NAFLD onset as they age into puberty. The central study supporting the 3 aims is a 1 year randomized prevention trial with a 1 year follow-up observational study in children who are pre-pubertal at baseline and who are known to be in a high-risk group for developing NAFLD because of Hispanic ethnicity and a first degree relative with NAFLD or type 2 diabetes. The intervention will replace typical drinks and food high in (non-dairy) sugars with low or no sugar foods using our established methods including 1) provision of food for the entire family 2) facilitated grocery shopping 3) home visits 4) behavior change counseling and, 5) frequent monitoring. Hispanic children age 7-9 years, Tanner stage 1, who are at high risk of NAFLD by family history will be randomized to LFSD intervention or usual care with matching for contact hours. The primary outcome is hepatic steatosis by MRI-PDFF at 1 year. Aim 1 tests whether the intervention protects against increase in hepatic steatosis at 1 year and NAFLD onset at 2 years. Aim 2 tests gene variants associated with NAFLD, baseline anthropometrics and insulin sensitivity modifiers of the impact of LFSD on change in hepatic steatosis at 1 year. Aim 3 explores biochemical and lipid metabolism mechanisms underlying hepatic steatosis and LFSD. In summary, this trial will generate evidence regarding the potential for using free sugar restriction as a NAFLD prevention strategy for children at increased risk of NAFLD. The findings will have sustained and significant implications for health promotion in Hispanic children, reduce health disparities, and inform future prevention efforts for children at increased risk of NAFLD.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $571,406 )
2025	2025	EMORY UNIVERSITY	201 DOWMAN DR NE	ATLANTA	GA	30322	DEKALB	USA	Nursing Research	002	5	4/11/2025	NON-COMPETING CONTINUATION	$57,141
2025	2025	EMORY UNIVERSITY	201 DOWMAN DR NE	ATLANTA	GA	30322	DEKALB	USA	Nursing Research	001	5	2/14/2025	NON-COMPETING CONTINUATION	$514,265
2025	2024	EMORY UNIVERSITY	201 DOWMAN DR NE	ATLANTA	GA	30322	DEKALB	USA	Nursing Research	000	4	2/14/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $571,406

Issue Date FY: 2024 ( Subtotal = $556,199 )
2024	2024	EMORY UNIVERSITY	201 DOWMAN DR NE	ATLANTA	GA	30322	DEKALB	USA	Nursing Research	001	4	5/3/2024	NON-COMPETING CONTINUATION	$55,620
2024	2024	EMORY UNIVERSITY	201 DOWMAN DR	ATLANTA	GA	30322	DEKALB	USA	Nursing Research	000	4	3/11/2024	NON-COMPETING CONTINUATION	$500,579
														Subtotal = $556,199

Issue Date FY: 2023 ( Subtotal = $576,074 )
2023	2023	EMORY UNIVERSITY	201 DOWMAN DR	ATLANTA	GA	30322	DEKALB	USA	Nursing Research	001	3	2/21/2023	NON-COMPETING CONTINUATION	$576,074
2023	2022	EMORY UNIVERSITY	201 DOWMAN DR	ATLANTA	GA	30322	DEKALB	USA	Nursing Research	000	2	1/20/2023	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $576,074

Issue Date FY: 2022 ( Subtotal = $955,536 )
2022	2022	EMORY UNIVERSITY	201 DOWMAN DR	ATLANTA	GA	30322	DEKALB	USA	Nursing Research	001	2	4/20/2022	NON-COMPETING CONTINUATION	$58,544
2022	2022	EMORY UNIVERSITY	201 DOWMAN DR	ATLANTA	GA	30322	DEKALB	USA	Nursing Research	002	2	9/12/2022	SUPPLEMENT FOR EXPANSION	$370,104
2022	2022	EMORY UNIVERSITY	201 DOWMAN DR	ATLANTA	GA	30322	DEKALB	USA	Nursing Research	000	2	1/18/2022	NON-COMPETING CONTINUATION	$526,888
														Subtotal = $955,536

Issue Date FY: 2021 ( Subtotal = $620,659 )
2021	2021	EMORY UNIVERSITY	201 DOWMAN DR	ATLANTA	GA	30322	DEKALB	USA	Nursing Research	000	1	4/5/2021	NEW	$620,659
														Subtotal = $620,659

Grand Total All Awards = $3,279,874

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Prevention of Pediatric NAFLD in Hispanic Children

Award Number: R01NR019083

ORGANIZATION: NATIONAL INSTITUTE OF NURSING RESEARCH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 04/05/2021

PERIOD OF PERFORMANCE END DATE: 01/31/2026

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