A $3.85 million NIH trial led by Melanie Bean, Ph.D., tests whether behavior coaches on video can deliver the intensive treatment national guidelines recommend but few teens ever get.

More than 1 in 5 American adolescents has obesity — 22.9% of those ages 12 to 19, according to federal survey data, a rate that has reached record highs for children and teenagers. And while effective treatment exists, is well-studied and is endorsed by national guidelines, almost none of them will receive it.

The gap between what works and what families can access is the problem a new clinical trial at Virginia Commonwealth University is working to solve.

Backed by a five-year, $3.85 million grant from the National Institutes of Health, the trial tests a model called Virtual Housecalls. The premise is simple to state and unusually difficult to execute: take the intensive lifestyle treatment that ordinarily happens in specialty clinics with long waitlists, and deliver it instead through a family’s pediatrician — with most sessions conducted by video, in the home.

Leading the study is Melanie K. Bean, Ph.D., professor of pediatrics and psychiatry at VCU School of Medicine and co-director of the Healthy Lifestyles Center at Children's Hospital of Richmond at VCU, with Shari Barkin, M.D. M.S.H.S., of Emory University School of Medicine as co-principal investigator. Bean also co-leads the Resources and Service Module at VCU's C. Kenneth and Dianne Wright Center for Clinical and Translational Research, Virginia's only NIH-funded Clinical and Translational Science Awards hub.

The approach begins with a question that has little to do with body mass index (BMI) charts. Bean's team grounds their work in motivational interviewing, which starts by asking adolescents what matters to them.

"We don't assume health is someone's motivator," Bean said. "We ask: Why would this be important to you? What would your life look like if you were successful?"

The answers are rarely clinical. A teenager wants to try out for soccer in high school. Another wants to feel confident at homecoming. A third has watched a parent live with Type 2 diabetes and would like to avoid it.

"Just helping them see their goals met and their confidence gained — those are all so rewarding," Bean said.

Reaching those goals, though, takes far more contact with the health care system than most families ever get. The American Academy of Pediatrics and the U.S. Preventive Services Task Force both recommend at least 26 contact hours of intensive health behavior and lifestyle treatment for children and adolescents with obesity, delivered over three to 12 months, and are explicit that treatment works better with more contact.

The challenge is providing that level of contact.

"It is extremely rare that pediatricians have 26 hours available to treat obesity," said Bean. “This number becomes even more unrealistic to attain when you consider the number of children and adolescents who have obesity. To actually find 26 hours where they can see them — and then also considering the amount of missed work and school for the kids and parents to come in — it just doesn't happen."

Where the 26 hours do happen is in research trials and tertiary care centers like the Healthy Lifestyles Center at Children's Hospital of Richmond at VCU, which Bean co-directs. But access to these specialty centers and programs is limited and can be a long drive. Bean estimated some practices in her study sit as much as 50 miles from Richmond.

"If you had to come to a tertiary care center for 26 visits, 50 miles away — that's a lot of gas for any family," she said. "We know that there are far more patients who have obesity than can be treated in tertiary care centers, or that have access to a research trial."

Virtual Housecalls meets families where they already go and where trust is already established, embedding certified behavior coaches into primary care practices and connecting them to families by video.

Adolescents in the intervention group — Coach Connect —  get quarterly in-person visits with their own pediatrician, weekly coaching sessions for three months and biweekly sessions for three more, plus weekly exercise videos, together adding up to the recommended 26 hours. Sessions cover healthy eating, physical activity, sleep, screen time and managing setbacks, with separate modules for parents, and are delivered in English and Spanish.

Telehealth removes the travel, the missed work and the missed school. But Bean points out that it also adds something.

"It's using telehealth as a way to have a window into families' homes," she said. "That's where most eating and exercise choices are actually made. So if the session is on sugar drinks, you might say, 'Let's look in your fridge — can we make a low-sugar drink with what you have available?' Or, 'Let's look at your pantry. What's at eye level for the kids?'"

The placement within primary care practices is deliberate. "We want our pediatricians to invite families to participate in a treatment they're offering at their practice, not refer them out," Bean said. “Coaches are considered part of the care team, and we provide pediatricians with feedback reports about the patient's progress in the program so that they can integrate this information into their patient care.”

The trial is guided by a Patient Advisory Board of teens and parents, several of whom lead the weekly exercise videos, and an Expert Advisory Committee.

The randomized trial will enroll 250 adolescents ages 12 to 15 with Class I (non-severe) obesity, along with a parent or caregiver. Nine community pediatric practices have signed on, phased in across three tiers, with recruitment now underway. A comparison group receives enhanced usual care. Statistical design and analysis come from investigators in the Wright Center's Biostatistics, Epidemiology and Research Design core, who serve as co-investigators.

The study’s primary measure is BMI change at six months, with follow-up at 12 months. Secondary goals are related to dietary and physical activity changes. A third goal is to examine how the amount and type of contact relates to results — whether 26 hours is truly the threshold. The team’s longer-term goal is a package that a primary care practice could adopt outright, and eventually a case for insurers to cover it.

"Adolescence is kind of the last opportunity for family-based care before you enter into emerging adulthood and you're mostly on your own," Bean said. "If we can stop the progression to severe obesity and help teens get empowered with these tools, that's years of confidence and health gained, and medical problems hopefully avoided."

"Our pediatricians were so excited about this and just really grateful for this partnership," Bean said. "Our current focus is about making sure we're delivering the best, most quality program — for patients and pediatricians."

Additional investigators on the study include, from the VCU School of Medicine:

• Edmond “Trey” Wickham III, M.D., M.P.H., associate professor of medicine and pediatrics and chief of the division of Endocrinology, Diabetes, and Metabolism in the Department of Internal Medicine
• Alyssa Button, Ph.D., assistant professor in the Department of Psychiatry
• Katlyn "Katie" Garr, Ph.D., L.C.P., assistant professor in the Department of Pediatrics
• Jennifer Lambert, M.D., assistant professor in the Department of Pediatrics

And from the VCU School of Public Health:

• Roy T. Sabo, Ph.D., professor in the Department of Biostatistics

Learn more about research at CHoR.

By Christopher Richmond

This story was originally published on the C. KENNETH AND DIANNE WRIGHT CENTER FOR CLINICAL AND TRANSLATIONAL RESEARCH VCU BLOG.