BOSTON--(BUSINESS WIRE)--Harvard Pilgrim Health Care Institute has been approved for a $4.5 million funding award by the Patient-Centered Outcomes Research Institute (PCORI) to study the potential relationship of antibiotics given to babies and toddlers with development of obesity later in childhood.
The observational study will look at data collected over a 5 to 10-year period among more than half a million children from 42 health systems participating in PCORnet, the National Patient-Centered Clinical Research Network.
“When farmers give antibiotics to live stock, they grow fatter. Now we are concerned that the same may be happening to babies,” said Harvard Pilgrim Institute Principal Investigator Matthew W. Gillman, MD, SM, who is leading the study alongside two other Principal Investigators, Christopher Forrest, MD, PhD, Professor of Pediatrics at Children’s Hospital of Philadelphia and Douglas Lunsford, Patient Investigator and Parent Member of the Nationwide Children’s Hospital Healthy Weight Program and co-founder of the Healthy Weight Community. “Our core theory is that antibiotics that young children take may change the bacteria that normally inhabit our gut in ways that lead to excess weight gain.”
Study investigators will examine relationships between antibiotics, especially broad spectrum antibiotics prescribed in early infancy or in multiple courses, and weight gain until the ages of 5 and 10 years. They will also look carefully at patient subgroups--boys and girls, major racial/ethnic groups, whether the mother had a cesarean or vaginal delivery, and other factors—to see if the risk of obesity with antibiotics is of more concern in some patients than others.
"One of the most important aspects of this research project is that parents of young children and other stakeholders have been fully engaged in developing it from the beginning,” says Gillman. “That process has ensured that the study will address the issues that they care about most. These stakeholders will continue to be involved in all phases of the study, including one part that includes focus groups to identify how parents and clinicians incorporate information about long-term risks of obesity into decisions about type, timing and the amount of antibiotics prescribed to infants.”
PCORI has also approved a second $4.5 million study comparing bariatric weight loss surgery approaches that will be conducted by Group Health Research Institute of Seattle. Harvard Pilgrim Health Care Institute will help coordinate that study with the antibiotic study.
The study awards continue PCORI’s efforts to develop PCORnet, a large, collaborative research initiative designed to link researchers, patient communities, clinicians and health systems in productive research partnerships that leverage the power of large volumes of health data maintained by the partner networks. PCORnet will enable the nation to conduct clinical research more quickly and less expensively than is now possible and will ensure that research focuses on the questions and outcomes that matter most to patients and those who care for them.
The funding award to Harvard Pilgrim Health Care Institute has been approved by PCORI’s Board 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 in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better informed healthcare decisions.
About Harvard Pilgrim Health Care Institute's Department of Population Medicine
The Harvard Pilgrim Health Care Institute's Department of Population Medicine is a unique collaboration between Harvard Pilgrim Health Care and Harvard Medical School. Created in 1993, it is the only appointing medical school department in the United States based in a health plan. The Institute focuses on improving health care delivery and population health through innovative research and teaching.
About Harvard Pilgrim Health Care
Harvard Pilgrim Health Care is a not-for-profit health services company serving more than one million members in New England. Founded in 1969, the health plan has built its reputation on pragmatic innovation with a goal of lowering costs, improving care and enhancing the overall member experience. Harvard Pilgrim is known for its excellent clinical programs, customer service, health improvement strategies and innovative tools that offer consumers greater transparency and empower them to make better decisions about their health care. Harvard Pilgrim consistently ranks among America’s highest-rated private health plans according to an annual ranking of the nation’s best health plans by the National Committee for Quality Assurance (NCQA)*.
* NCQA’s Private Health Insurance Plan Rankings, 2011-15, HMO/POS/PPO. NCQA’s Health Insurance Plan Rankings 2010-11 – Private. U.S.News/NCQA America’s Best Health Insurance Plans 2005-2009 (annual). America’s Best Health Insurance Plans is a trademark of U.S.News & World Report. NCQA The State of Health Care Quality 2004.