Not-So-Secret Formula Enhancing Recruitment For An Organic Infant Formula Trial

The breast milk substitute (BMS) industry is known to mislead the public regarding the value of their baby formula products.

The WHO and UNICEF published a report on how aggressive marketing has pushed mothers and health providers away from the benefits of breastmilk in favor of the unproven benefits of formula milk.¹ It is common for BMS manufacturers to promise qualities “closer to/inspired by” breastmilk, despite containing synthetic, lab-made ingredients.²

However, breastfeeding is not feasible for some mothers, including those undergoing cancer treatment, those with HIV/AIDS, or those using illicit substances.³ Organic BMS formula creators are now seeking to fill these mothers’ needs in an open and industry-regulated way. This way of operating implies transparent ingredient lists, rigorous testing, and the pursuit of FDA approval.

The clinical trial industry has changed to expect trial populations to represent all races and ethnicities. In the US, this remains a difficult task. There are many historical, cultural, and institutional barriers to diverse clinical trial recruitment. Mistrust is often higher for guardians of infants.

Infant nutrition has become part of the health equity conversation because non-Hispanic Black women and Hispanic women have more barriers to breastfeeding postpartum.⁴ For those who cannot breastfeed, a proven BMS becomes their best option.

In early 2021, a customer tasked Acclinate with helping them recruit participants for an organic infant formula trial. Again, diversity was essential to the primary investigator and executive leaders. However, the customer’s decentralized trial was suffering low participation, despite having traveling nurses available in 12 different large cities at the time.

The customer anticipated difficulty recruiting diversely from their target demographic: pregnant women due less than two weeks after enrollment. In addition, the large trust gap between communities of color and the healthcare industry made diverse recruitment even less likely.

Acclinate proposed a pilot program to assess and improve the customer recruitment process. With Acclinate’s targeted engagement strategy, the customer could finally begin approaching target participants more effectively.