FPG Clinical Case Studies

I’m Eating – Infant Supplement Study

FPG partnered with Northwestern University Feinberg School of Medicine to facilitate a research study to determine how 5 to 12 month old infants would tolerate a nutritional supplement that introduced a proprietary blend of proteins from common allergenic foods into their diet. Phase one required the recruitment of 700 infant-parent pairs and lasted 6 months. Participants kept an online diary and completed an online questionnaire at the end of both 28-day usage periods. Titled “I’m Eating,” research partners also included the Institute for Public Health and Medicine, and the Center for Healthcare Studies. After the successful completion of the study, FPG was asked to extend the research to a full year with 200 participants (the placebo group) from Phase 1 continuing with the study.

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NIX Toolbox

The NIH toolbox is a comprehensive set of neuro-behavioral measurements that quickly assess cognitive, emotional, sensory, and motor functions from the convenience of a laptop. This was the first collaboration between FPG and Northwestern and was the study that supported development of the Toolbox program. Over the course of four months, FPG recruited and completed interviews with 4,410 participants ranging in age from 3-85. These interviews took place in 10 locations, which detailed requirements and quotas for respondents at each location. The sample included 1,000 adults, 1,700 children, 1,300 pediatric participants, 200 mothers of pediatric participants, and 210 pregnant women. Beyond this, there were additional distribution requirements with respect to race, ethnicity, education, and income level. Northwestern trained the Company’s staff to administer standardized tests covering cognition, motor, and sensory skills. Our staff also took saliva samples from each respondent. Throughout data collection, members of the project management staff audited the work done at each location to ensure that research followed protocols and processes.

National Children’s Study

Northwestern was selected as a regional lead in the Vanugard Study, a program under the National Children’s Study (“NCS”). NCS was a large-scale, long-term study of U.S. children and parents designed to understand environmental influences on child health an development, authorized by the Children’s Health Act of 2000. Northwestern subcontracted with FPG to conduct data collection for 1,100 children utilizing a medical mobile van in several counties throughout Texas, Arkansas, New Mexico, Mississippi, Louisiana, Tennessee, Georgia, and Florida. FPG completed phone interviews and handled consent-to-participate calls from their St. Louis Call Center. For any consents that were completed over the phone, the Company’s field staff obtained a signature page at the next in-person visit. Data collection took place in participants’ homes or at Company locations. During these visits, project staff conducted interviews, neurological testing, anthropometric measurements, and collected biological specimens (urine, saliva, and blood). English and Spanish-speaking staff were made available. These data collectors were all recruited and trained by FPG clinical professionals.

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