by Christina Echegaray

Vanderbilt University Medical Center has received a $10 million, five-year research funding award from the Patient-Centered Outcomes Research Institute (PCORI) to study the ideal “dose” of behavioral interventions to treat childhood obesity in rural and minority communities across Tennessee and Louisiana.

Bill Heerman, MD, MPH, chief of the Division of General Pediatrics a Vanderbilt, will lead the randomized, multisite trial with co-principal investigator Amanda Staiano, PhD, at Louisiana State University’s Pennington Biomedical Research Center.

Despite ongoing efforts, childhood obesity rates have continued to increase over the last 10 years, with about 1 in 5 children across the U.S. affected by obesity. The prevalence of childhood obesity is higher among children who are underrepresented minorities and those who live in rural areas due to health disparities and limited access to interventions. Across the U.S., about 22% of Hispanic or Latin American and 20% of African American children have obesity compared to about 14% of white children. Additionally, obesity affects about 22% of children who live in rural areas.

Researchers in the Dose Childhood Obesity Trial will study the optimal duration of behavioral interventions, including number of sessions and length of sessions, which are best in treating childhood obesity among these groups.

“We know that one-size fits all approaches to treating childhood obesity don’t work. This trial is an opportunity to understand what works best and for whom,” said Heerman, associate professor of Pediatrics and a general pediatrician at Monroe Carell Jr. Children’s Hospital at Vanderbilt.

Researchers plan to enroll 900 parent-child pairs, with children ages 5 to 17 who have obesity and are from rural and minority communities in Tennessee and Louisiana, where childhood obesity rates are among the highest in the country. Underserved communities often have unequal access to evidence-based obesity interventions, contributing to the higher rates among these populations.

Children are diagnosed with obesity if their body mass index is at or above the 95^th percentile for their age and gender category. The long-term risks associated with childhood obesity include Type 2 diabetes, hypertension and heart disease.

Current American Academy of Pediatrics (AAP) recommendations call for children with obesity to receive an intensive behavioral intervention of 26 hours of face-to-face, family-based treatment over six months. These evidence-based behavioral and lifestyle interventions can include regular check-ins with primary care physicians, personalized nutrition plans, healthy learning modules and more.

In the study, researchers will compare how different “dosing” combinations of face-to-face intervention time may be optimized to help reduce a child’s weight over 12 months and impact a child’s diet, physical activity, sleep, media use and quality of life. Specifically, they want to examine: is the intensity of the AAP-recommended 26 hours needed, or can a reduced-intensity behavioral intervention between 13 and 22 hours be effective in treating childhood obesity and increasing reach to underserved communities?

The parent-child pairs will be randomly assigned to one of five study arms (26, 22, 19, 16 and 13 hours) of the trial.

The types of interventions for each arm will be the same and include: primary care physician visits; on-demand web-based content that includes learning modules on topics such as choosing healthy foods, being an active family, the importance of sleep; community resource counseling with social or community health workers; and parent-child personalized nutrition services with certified nutritionists. The difference between the arms will be in the frequency and duration of the personalized nutrition counseling.

Speaking about the potential impact of this study, Heerman said, “By testing the optimal dose of behavioral interventions for childhood obesity, we hope to inform future treatment recommendations and build pragmatic solutions that can reach the millions of children with obesity in the United States.”

The research team and scientific advisory board includes researchers from Vanderbilt and Pennington, representatives from the American Academy of Pediatrics, multiple international experts in childhood obesity interventions, and patient representatives.

VUMC’s award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.

PCORI is an independent, nonprofit organization authorized by Congress with a mission to fund patient-centered comparative clinical effectiveness research that provides patients, their caregivers and clinicians with the evidence-based information they need to make better informed health and health care decisions.