Will Ahmed, founder and CEO of the 10-year-old company, explained the findings in a video. “It’s the first time women can say, ‘Hey, we’re seeing things that indicate you should talk to your doctor,'” she said.
Now, however, those breathless claims are drawing criticism as premature and scientifically shaky. There were complaints On many fronts A former HOOP employee who worked on the pregnancy aspect, an obstetrician-gynecologist at West Virginia Medical School who co-authored the study, and two prominent physicians specializing in preterm labor.
Keely Byrne served as product manager for the feature, but left Hoop before its release in October because the company was rushing the initiative and relying on weak science. She shared her concerns with a supervisor at her exit interview, but they were not addressed. On November 9, Whoop issued a news release, “Whoop Identifies Novel Pregnancy Digital Biomarker for Screening for Preterm Birth.”
“I was surprised at how deceptive Hoop’s Instagram and direct email marketing was on the pregnancy training aspect,” Byron, who now works as a contract employee for drugmaker Gentech, told the Globe. “A normal person would look at these ads very reasonably, and Hoop could help them find out if they’re at risk for preterm labor, which the product doesn’t do anything.”
Dr. Shawn Rowan, a West Virginia OB-GYN and one of the study’s authors, said the discovery that an expectant mother’s heart rate changes seven weeks before giving birth to both full-term and preterm babies was shocking. But Hoop’s marketing claims have left him feeling “a little hesitant.” The study was published online in November, but has yet to withstand the scrutiny of peer review. Publication in a scientific journal. “From a scientific perspective, I don’t think we’re there yet,” Rowan said.
In a series of emails, Hupp said the company stands by its research and product. As for the company’s claims about the pregnancy feature, Hupp insisted the company has merit to its invention, saying it “has the potential” and could “lead to screening for fewer births.”
“We did not claim in the marketing campaign that the device ‘predicts premature births,'” the company said. Hupp said he plans to do more research, and for now, expectant mothers can use the feature to see “contextual” exercise trends with their pregnancy.
Hupp said the feature expressly states that the company “does not provide medical advice and its services are not intended to be a substitute for the advice of your physician or other medical professionals.”
Many doctors have raised doubts in recent years about whether tech companies’ claims for wearable devices — a $52 billion global market last year, according to one estimate — keep pace with medical science. A cardiologist at the University of California, San Francisco, one of the first to investigate the ability of smartwatches to detect potentially dangerous irregular heartbeats, wrote in the journal Circulation on Monday that more research is needed before such products can be considered reliable.
Whoop, the controversy comes at an important time. The privately held company has generated considerable buzz and has a market cap of $3.6 billion by 2021. Unlike other fitness tracker makers, Woop uses a subscription model; Customers pay $30 a month, which includes a screen-less watch and access to a smartphone app. But in July, Hoop announced it was laying off 15 percent of its staff due to uncertainty in the tech market, leaving about 500 workers.
A decade ago when Ahmed was a student at Harvard University, where he was the captain of the men’s varsity squash team, Woop sells watches and, among other things, “Heart rate variability,” or HRV, measures small variations in the time between heart beats. If a person’s heart rate is 60 beats per minute, the heart does not actually beat once every second, according to Hoop’s website. Within that minute, there may be 0.9 seconds between two beats and 1.15 seconds between the other two beats.
HRV may appear to be a function of the heart, but it’s actually generated in the nervous system and is an important measurement of fitness, according to Hoope. People with high heart rate variability, the company says, are generally in better shape and willing to push themselves. The band also tracks resting heart rate, or RHR, another important measure of conditioning, Hupp says. Generally, a low heart rate is a good sign.
Rowan said she turned to the hoop a few years ago for a small study on the benefits of exercise for pregnant women. With a grant from West Virginia University, she paid Hoop about $20,000 for wristbands worn by 18 women during and immediately after pregnancy, she said. The fabric bands contain sensors and collect health data when people wear them 24 hours a day. The data is automatically uploaded to the Hoop app.
All 18 women carried their pregnancies to term. (According to the American College of Obstetricians and Gynecologists, a pregnancy is considered full-term at 37 weeks.) Given the stress a growing fetus puts on a woman, Rowan said the volunteers’ cardiovascular health was not surprising. measured by HRV and RHR – worsened during pregnancy. But seven weeks before delivery something unexpected happened, he said. This trend automatically reversed, and their fitness rapidly improved pre- and post-partum, as evidenced by HRV and RHR data.
“Why would it be reversed?” said Rowan, lead author of the study, co-authored by five West Virginia University researchers and recently published in the journal BMC Pregnancy and Childbirth. “I’ve talked to some people who have what I think are wonderful ideas about the physiology of pregnancy. No one can answer.”
After that study was completed, Woop began a second study, conducted by Rowan, a university colleague, and three other researchers from the institute. The company collected retrospective data on 241 women who wore the wristband during pregnancy, including 21 who had babies born prematurely. Regardless of whether the babies were born on time or prematurely, the study showed that the mothers’ cardiovascular fitness worsened until seven weeks before the onset of labor, when it quickly improved. If a woman notices inversion at 25 weeks of pregnancy, it may indicate that her baby will be born prematurely at 32 weeks.
Hupp called the sudden reversal a “whoop inflection point” and said the dynamic “has the potential to save lives.” According to experts, approximately 10 percent of American babies are born prematurely. Such births constitute the second leading cause of infant deaths after birth defects, and often contribute to health problems in surviving infants.
Many doctors would welcome an affordable, reliable and non-invasive method for expectant mothers of premature births. Currently, they can perform ultrasounds in the second trimester to see if a woman’s cervix has narrowed, which increases the risk of preterm birth. Other doctors take a sample of vaginal fluid to check for a protein that helps the amniotic sac stick to the uterus; If it’s in fluid, it could be a sign of preterm labor.
According to Frances Miller, a professor at Boston University School of Law and an expert on the FDA, a wearable that could screen for premature births should be cleared by the US Food and Drug Administration. But the burgeoning wearables market occupies a gray zone in the agency’s regulations, and “the FDA can’t afford to keep up,” he said. Hupp said the FDA will do what it needs if the agency needs approval for the feature.
Two prominent OB-GYNs specializing in preterm births said it took longer than an unpublished study of 241 pregnancies before they would recommend the hoop wristband.
A professor at Washington University of Medicine, Dr. Michael Gravett, although the study is intriguing, does not address several factors that increase the likelihood of preterm births, including patients’ race, ethnicity, and socioeconomic status. Researchers, he said, “need to account for the multifactorial nature of preterm birth.”
Dr., who runs the prenatal clinic at Brigham and Women’s Hospital. Thomas McIlrath says the study needs to be not only peer-reviewed, but repeated in a different group of pregnant women to force heart rate. The change could mean premature birth.
Meanwhile, another OB-GYN quoted in Hoop’s press release last month is walking back his comments.
Chief Medical Officer of New Jersey-based Axia Women’s Health, Dr. Elizabeth Cherot was quoted as saying that the Hoop study was “incredibly important” in light of the problem of premature births. Eight days later, Serrod was named chief medical officer of the March of Dimes, a prominent nonprofit group dedicated to preventing premature births.
In a recent Globe interview, Serrod acknowledged that the study was not peer-reviewed and had other flaws. He did not endorse the product, a research effort to find an innovative, non-invasive screening tool.
“I have to say I’m incredibly excited,” he said.
Jonathan Saltzman can be reached at jonathan.saltzman@globe.com.
