Case Study: Child Nutritional Supplement Trial
FPG recruited 700 infants/parents in four weeks, leveraging its national panel of research participants.
During February of 2017 Focus Pointe Global (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. 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 for a longer-term understanding of the impact of future outcomes of children’s allergies. When asked if they wished to continue to participate for an additional period of time (one year), 85% of the parents accepted the offer, agreeing to continue using the supplement Phase 2 is currently underway for 12 months. FPG ships the product to participants each month. Participants no longer complete daily diaries but do monthly surveys covering any potential adverse event experiences and monthly product usage questions. We continue to have zero adverse events requiring pediatrician follow-up related to the supplement.
Focus Pointe Global project facilitation included:
- Designed all study documents and worked with the IRB for study and document approval
- Managed $1 million+ budget
- Collected in-home bio-specimens (blood samples) from babies through a mobile Phlebotomy service provider
- Managed participation (daily diary and end of period online questionnaires) and compliance, including distribution of stipends
- Mailed the test product to participants’ homes
- Executed the project online, reducing the burden of travel time for parents
- Designed and executed a retention program to keep participants engaged in the process ‘I’m Eating’ Study