Closing the gap: Breaking weight-based stigma in clinical trials

The narrative that’s been peddled for the past three decades has seen obesity become mired in controversy, leading many – even healthcare professionals – to view it as a lifestyle choice rather than a disease.

Nearly 40% of the global population has a body mass index (BMI) higher than 25 kg/m2, meaning they’re overweight or obese. By 2035, this number is expected to hit 51%. At these levels, obesity is and will continue to be a major public health problem. Adults with high BMIs are at increased risk for several serious health conditions, among them heart disease, cancer, stroke, type 2 diabetes and severe COVID-19 outcomes.?

In the U.S., the problem continues to escalate. As of 2022, 35% of adults in 22 states were living with obesity. A stark contrast to 2012 when no state had an adult obesity rate over 35%.?

Stigmatized health care

For adults with high BMIs, seeking healthcare can be a fraught experience. Patients routinely report being stigmatized in healthcare situations, with those living with obesity saying they feel judged ?by healthcare providers. There is a growing body of evidence to suggest that, in turn, providers spend less time, offer less education, and deprioritize building a rapport with these groups. Patients with obesity are also frequently subjected to unsolicited advice, with their weight tending to drive medical conversations even when they seek treatment for an unrelated issue.

Phelan et al .’s 2021 study into weight-based stigma concluded that those with higher BMIs are more likely to feel judged by their healthcare providers and experience discrimination. The researchers identified two aspects of interpersonal care that particularly impacted the experience of these patients: more frequent occurrences of stigmatizing situations and less patient-centered communication. BMI was also found to be correlated with less-perceived respect from healthcare professionals.?

The result is a vast and growing swathe of the population is underserved in healthcare arenas and so actively avoids them. Those with BMIs over 24.9 are most likely to delay seeking healthcare when they need it or change primary doctors more frequently.??

Representation matters

This experience means that enrolling patients with high BMIs into studies is challenging in a clinical trial environment. Their avoidance of and experience with healthcare more generally means they’re less likely to be aware of trials and far more reticent to sign up even if they do know about them.?

Yet, including these groups is vital to outcomes for both Sponsors and patients. Without it, we have no means to understand how people who are overweight or living with obesity respond to certain protocols or develop targeted solutions for these groups.?

This is a large and growing percentage of the U.S. and global population — one at high risk from various serious conditions — and we can’t afford to ignore those who are overweight and obese in the trial environment.?

Health equity in action

Understanding how patients who are obese and overweight experience healthcare settings generally, and ensuring trial environments are welcoming and inclusive, is the only way to increase their engagement with clinical trials.?

Ensuring?diversity, equity, and inclusion across our clinical trial sites is a core focus for the Velocity team. It is part of our three-year commitment to working towards 1:1 patient enrollment to match population demographics. Nadege Gunn, MD, CPI, DABOM , is a principal investigator at Velocity’s site in Waco, Texas, who has been instrumental in building processes and protocols that are inclusive of the community living with obesity. She is board certified in obesity medicine, and is a leader of Velocity’s metabolic dysfunction-associated steatohepatitis (MASH) CARE Council .?

A specialist in steatotic liver disease, Dr. Gunn has decades of experience treating a variety of patients, including those with high BMIs. She believes that increasing the involvement of these patients begins with demonstrating sensitivity.?

Dr. Gunn is quick to point out that patients with obesity avoid treatment because they’re uncomfortable in healthcare settings, “There are a lot of things we do to make individuals with high BMIs feel more comfortable when they walk into our centers,” she explains. “The first is to recognize sensitivity around language and how we address this. That includes knowing what not to say to a patient with obesity — unsolicited advice has no place in our clinics.”?

The Phelan study also found that identity threat, while partly unconscious, makes those with high BMIs uncomfortable and can prevent them from attending follow-ups and seeking care in the future. “Clinical trial personnel — like all health care professionals — need to be professional in their demeanor and anticipate the unique equipment needs of those living with obesity,” says Dr. Gunn. “We want to make sure that the blood pressure cuffs are large enough, that the beds can comfortably accommodate larger patients, and that the scales can exceed a 350l-pound weight capacity. It’s also important to weigh people in private locations and avoid responding negatively to the number on the scale when these patients are weighed.” This contributes to ensuring an environment of psychological safety for these groups and avoids situations where they are subjected to identity threats.

In addition to inclusive procedures and protocols, there is a need for clinical trials to meet patients where they are. Obesity occurs at differing rates within populations, and rural and minority communities often experience a higher prevalence . “We need to engage with the communities that are primarily affected by obesity,” Dr, Gunn explains, “And show them that, as far as clinical research is concerned, there are opportunities for them that can improve their quality of life. That means partnering with healthcare providers and community groups to educate them on how they can seek treatment for the disease that obesity is.”?

The path to inclusive healthcare

Clinical trials represent an opportunity to address and reduce healthcare disparities. This is especially true for underserved groups, such as obese and overweight patients, who often avoid health care due to discomfort with the environments in which it is offered.?

Ensuring these groups are aware of and comfortable participating in clinical trials will increase their representation and ensure that advancements in healthcare benefit everyone, helping to foster a more inclusive and equitable health system.