Trial to correlate food allergy prevention with lower health care costs
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Key takeaways:
- The trial will test the use of food supplements that include allergens in preventing allergies.
- The researchers hope reduced costs will incentivize insurance companies to cover these supplements.
The Early Allergen System Experience trial will use real-world infant health care data to assess how the early introduction of allergens via supplements will impact the development of allergies and associated health care costs.
“We are excited to help show that preventing food allergies can create significant savings for insurance companies, which should encourage them to invest in food allergy prevention,” Daniel Zakowski, CEO and cofounder of Ready. Set. Food!, told Healio.
Ready. Set. Food! is partnering with ObvioHealth to conduct the study with the goal of showing insurance companies the opportunities that leaning into food allergy prevention has on their return of investment.
Previous studies have shown that early allergen introduction can prevent most food allergies, which can save patients and insurance companies money over a lifetime of care, but there are also some barriers as to why so few families and practitioners actively engage in this practice.
“Our secondary goal is to show how much easier it is to implement food prevention guidelines using Ready. Set. Food! than it is than doing it yourself,” Zakowski said. “We’re happy any way that parents will do food allergy prevention, but we know that the largest clinical trial had less than 50% compliance and it’s because it’s hard to get parents to feed the baby these allergens.”
The trial will enroll 1,100 infants aged 2 to 5 months, randomly assigned to an intervention group receiving Ready. Set. Food! Mix-Ins or a control group following their pediatrician’s guidance for food introduction, which usually consists of caregivers introducing allergens into their infant’s diet between age 4 to 6 months, according to the U.S Department of Agriculture. The study will be done remotely with no physical visits.
“[Participants] will download an app onto their own device, and that’s where they will carry out all their study activities, including the e-consent process and completing the study questionnaires,” Florence Mowlem, PhD, vice president of science at ObvioHealth, told Healio.
“I think it’s important to note that even though this is being done remotely and enabled by digital data collection, we still have that human element. So, there’s still a team behind all of that who are supporting the participants throughout the study,” Mowlem added.
The study is also hoping to reach a more diverse set of participants and has exceeded its enrollment targets to date, according to Sara Koors, executive vice president of research and science for Ready. Set. Food!
“We just launched in March and we’ve more than fulfilled the enrollment allocation that we were hoping for,” Koors told Healio. “We’re proving that Ready. Set. Food! works, but in this experience, we’ve also gleaned the knowledge that this can be done effectively for parents across different socioeconomic statuses and different environments.”
The study will track data for 2 years. Assigning each participant a unique encrypted “token” will allow the study team to track visits to practitioners for allergy-related events, therefore enabling access to real world data. The Ready. Set. Food! product used in the study is a powder that can be mixed in with breast milk, formula or food that introduces cow milk, then eggs, and then peanuts in a step-by-step process.
“The key is that we’re just trying to package up all the different best practices from a medical perspective into a once-daily packet that parents can easily feed their baby,” Zakowksi said.
The study hopes to innovate the way that food allergies are treated and, most importantly, prevented by making access to early allergen introduction methods feasible to all populations.
“A lot of parents won’t be able to afford products to help them feed babies allergens early enough, and those parents are also the ones that can least afford to have their baby develop food allergies,” Zakowski said.
Ultimately, Zakowski emphasizes that having insurance companies investing in early allergen introduction will be the driving force for change.
“I know we can really demonstrate the savings to them, which we’re able to do with Obvio’s innovative research model,” he said. “Demonstrating those savings is going to be what helps drive a lot of benefit for infants because you already have a situation where providers, doctors are excited. They have medical guidelines saying every baby should do it. What we now need is insurance companies to lean in if we want this to be a public health solution.”
Reference:
- Ready. Set. Food! and ObvioHealth launch innovative trial to correlate infant food allergy prevention with reduced health care costs. https://www.obviohealth.com/resources/ready-set-food-and-obviohealth-launch-innovative-trial-to-correlate-infant-food-allergy-prevention-with-reduced-healthcare-costs. Published March 28, 2024. Accessed April 10, 2024.
For more information:
Daniel Zakowski, MBA, can be reached at daniel@readysetfood.com.