A research team at LSU's Pennington Biomedical Research Center has been approved for a five-year, $4.5 million funding award by the Patient-Centered Outcomes Research Institute, or PCORI, to evaluate two treatments for children who have obesity.
The researchers will look at which is more effective: counseling by a primary care provider focusing on healthy eating and activity habits or a combination of provider counseling and family-based treatment delivered by a trained counselor for both children and parents.
"We'll be working side-by-side with families, doctors, and other health providers to test our science-backed weight-management programs in pediatric clinics throughout Louisiana," said Amanda Staiano, director of the Pediatric Obesity and Health Behavior Laboratory at Pennington Biomedical and the primary investigator for the Louisiana portion of the study.
To accomplish the goals of this groundbreaking work, Pennington Biomedical will partner with Washington University School of Medicine in St. Louis, Missouri, the University of Rochester Medical Center in New York, and the Institute for Healthy Childhood Weight at the American Academy of Pediatrics. Total funding for the research is $14 million, which was secured through a rigorous and highly competitive national grant application program.
Among other things, Pennington Biomedical will recruit 432 families from doctors' offices in Louisiana, with each family participating for 18 months. Pennington Biomedical will also be helping to train providers to deliver weight-management interventions for children. In addition to the potential health benefit of this research for the State, the research center anticipates an important economic impact in the form of new high quality jobs and is anticipating the addition or supporting equivalent of roughly 20 full-time workers at Pennington Biomedical and out in the community over the life of the study.
Costs associated with clinical treatment will be paid by Louisiana Healthcare Connections through a demonstration project and Blue Cross and Blue Shield of Louisiana, which will reimburse members and providers for the services.
"Childhood obesity is an issue of critical importance in Louisiana because of its tremendous impact on long-term health and health outcomes. This project will provide the data and research necessary to drive improvements in care delivery and quality outcomes for obesity-related illnesses and chronic diseases in Louisiana," said Dr. Stewart T. Gordon, chief medical officer for Louisiana Healthcare Connections.
"We need to make progress in treating obesity in Louisiana, where we have one of the highest obesity rates in the country," said Vindell Washington, Blue Cross and Blue Shield of Louisiana chief medical officer. "Working with our partners at Pennington Biomedical Research Center through this grant could be a significant step forward. If we develop a model that supports providers in the treatment of obesity, we can intervene sooner to not only help patients get healthier, but also lower their risks for other co-occurring conditions like diabetes, heart disease, and high blood pressure."
Staiano said it's vital to address childhood obesity as quickly as possible. One in five children nationwide has obesity. In Louisiana, 34 percent of children aged 10-17 have overweight and obesity. Without intervention, they could become adults with obesity, with the risks of psychological and health challenges the disease brings.
At present, two of the most widely used guidelines-based treatments for children with obesity are those of the U.S. Preventive Services Task Force and the American Medical Association. The task force recommends that clinicians screen children 6 and older for obesity and immediately offer or refer them to a comprehensive behavioral intervention - at least 26 contact hours over a period of up to 12 months -- to promote improvement in weight status.
The American Medical Association recommends a different, staged approach to childhood obesity screening and counseling. Staged treatment begins with prevention counseling by the primary care provider and includes assessment of weight status and patient/family motivation and readiness to change. Treatment also includes promotion of healthy eating and activity habits and use of health-behavior change strategies. Intensification of weight-loss interventions increases based on a child's response to care. Although both approaches are being offered in pediatric clinics, services are scattered and not uniform.
"Pennington Biomedical's project will lead to improved delivery of obesity treatment to youth and their families in primary care practices in Louisiana and across the country. We look forward to supporting this project to ensure that reimbursement mechanisms and trained providers are available to expand access to evidence-based treatment for childhood obesity," said Dr. Rebekah Gee, Secretary of the Louisiana Department of Health.
Staiano said the data support acting promptly to address childhood obesity.
"Oftentimes if you wait six or 12 months or a couple of years, the child keeps gaining excess weight, and it gets harder and harder to get them off that path," Staiano said.
PCORI Executive Director Dr. Joe Selby, MD, MPH, said the project has the potential to answer an important question about childhood obesity treatments and fill a crucial evidence gap.
"We look forward to following the study's progress and working with Pennington Biomedical to share its results," Selby said.
Staiano's study was selected for funding through PCORI's Pragmatic Clinical Studies Initiative, an effort to produce results that are broadly applicable to a diverse range of patients and care situations and can be more quickly taken up in routine clinical practice.
Many clinical studies test whether a treatment works under ideal conditions in specialized research centers, but health care is rarely delivered in such idealized situations and settings. Pragmatic clinical studies test a treatment's effectiveness in "real-life" practice situations, such as typical hospitals and outpatient clinics, and also can include a wider range of study participants, making their findings more generally applicable.
Staiano's award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.