R01NR019083

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 the 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 the 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 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 aged 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 an 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 the 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.

Emory University

NURSES UNDERSTAND THAT IMPROVING HEALTH AND WELL-BEING MEANS ADDRESSING PEOPLE'S NEEDS IN MULTIPLE SETTINGS, CONTEXTS, AND OVER THE WHOLE LIFE COURSE. SCIENCE SUPPORTED BY THE NATIONAL INSTITUTE OF NURSING RESEARCH (NINR) USES THIS HOLISTIC PERSPECTIVE TO IMPROVE INDIVIDUAL AND POPULATION HEALTH AND ADVANCE HEALTH EQUITY. NINR-SUPPORTED RESEARCH PROMOTES HEALTH AND WELL-BEING BY ADDRESSING NEEDS AT MULTIPLE LEVELS INDIVIDUAL, FAMILY, COMMUNITY, AND SOCIETAL LEVELS AND DEVELOPING TREATMENT AND PREVENTION STRATEGIES THAT ARE RESPONSIVE TO THE REALITY OF PEOPLE'S LIVES. NURSES KNOW PEOPLE, AND PEOPLE TRUST NURSES. PATIENT AND FAMILIES INTERACT WITH NURSES MORE THAN ANY OTHER CLINICIANS. NURSING SCIENCE USES THIS SPECIAL RELATIONSHIP TO BETTER UNDERSTAND PATIENTS, FAMILIES, AND COMMUNITIES AND THE MANY FACTORS THAT INFLUENCE THEIR HEALTH. NURSING SCIENCE SUPPORTED BY NINR USES THIS KNOWLEDGE TO DEVELOP STRATEGIES FOR IMPROVING HEALTH AND WELLNESS ACROSS POPULATIONS, HEALTH CARE SETTINGS, AND THE LIFESPAN, WITH AN EMPHASIS ON ACHIEVING HEALTH EQUITY. NINR-SUPPORTED SCIENTISTS HAVE DEVELOPED INTERVENTIONS FOR: SUPPORTING PARENTS OF PREMATURE INFANTS, PROMOTING HIV PREVENTION IN UNDERSERVED POPULATIONS, IMPROVING TRANSITIONAL CARE LEADING TO BETTER OUTCOMES AND COST-SAVINGS, AND HELPING INNER-CITY CHILDREN MANAGE ASTHMA. NURSING SCIENCE TRANSCENDS THE BOUNDARIES OF DISEASE AND RESEARCH DISCIPLINES TO BETTER UNDERSTAND THE EXPERIENCES OF INDIVIDUALS AND FAMILIES LIVING WITH ILLNESS AND TO DEVELOP PERSONALIZED APPROACHES THAT MAXIMIZE HEALTH AND WELL-BEING FOR INDIVIDUALS AT ALL STAGES OF LIFE, ACROSS DIVERSE POPULATIONS AND SETTINGS. NINR-SUPPORTED SCIENCE USES NURSING SCIENCE'S UNIQUE, PATIENT AND COMMUNITY-FOCUSED PERSPECTIVE AND WIDE REACH ACROSS CLINICAL AND COMMUNITY SETTINGS TO ADVANCE OUR UNDERSTANDING OF THE SOCIAL DETERMINANTS OF HEALTH: THOSE FACTORS THAT ARE AT THE ROOT OF THE INEQUITIES THAT WE SEE, SUCH AS FOOD INSECURITY AND ACCESS TO HEALTHCARE. NINR RESEARCH EFFORTS IN WELLNESS INVESTIGATE THE KEY BIOLOGICAL, BEHAVIORAL, AND SOCIAL FACTORS THAT PROMOTE LONG-TERM HEALTH AND HEALTHY BEHAVIORS AND PREVENT THE DEVELOPMENT OF ILLNESS ACROSS HEALTH CONDITIONS, SETTINGS, AND THE LIFESPAN. RESEARCH IN WELLNESS IS ALSO FOCUSED ON DEVELOPING AND TESTING CULTURALLY APPROPRIATE INTERVENTIONS TO PROMOTE HEALTH AND PREVENT ILLNESS IN MINORITY AND UNDERSERVED GROUPS. NINR ALSO SUPPORTS SCIENCE TO ASSIST INDIVIDUALS, FAMILIES, AND HEALTH CARE PROFESSIONALS IN MANAGING ADVANCED, SERIOUS ILLNESS, AND PLANNING FOR END-OF-LIFE DECISIONS. IN ADDITION, NINR PROMOTES TECHNOLOGICAL ADVANCEMENTS THAT ADDRESS A RANGE OF HEALTH CARE CHALLENGES AND FACILITATE THE DELIVERY OF REAL-TIME PERSONALIZED INFORMATION TO INDIVIDUALS AND FAMILIES, HEALTH CARE PROVIDERS, AND COMMUNITIES. FINALLY, NINR HAS A LONGSTANDING AND CONTINUING COMMITMENT TO DEVELOPING THE NEXT GENERATION OF NURSE SCIENTISTS: THOSE INDIVIDUALS AND TEAM MEMBERS WHO WILL CARRY THE FIELD OF NURSING SCIENCE INTO THE FUTURE. IN ORDER TO PREPARE AN INNOVATIVE, DIVERSE, AND TALENTED NEXT GENERATION OF NURSE SCIENTISTS, NINR SUPPORTS A VARIETY OF TRAINING OPPORTUNITIES FOR SCIENTISTS AND TRAINEES AT ALL CAREER LEVELS, PARTICULARLY THOSE AT AN EARLY CAREER STAGE WHO ARE SO CRITICAL TO SUSTAINING THE FUTURE OF INNOVATIVE RESEARCH AND HIGH QUALITY HEALTH CARE.

93.361 - Nursing Research

National Institute of Nursing Research (NINR) [HHS - NIH]

Atlanta, Georgia 303221014 United States

Single Zip Code

Reducing Health Disparities Among Minority and Underserved Children (R01 Clinical Trial Optional) (PA-18-152)

Amendment Since initial award the total obligations have increased 428% from $620,659 to $3,279,874.