Obese patients in underserved areas benefitted from a lifestyle-based intervention delivered in primary care clinics in a cluster-randomized trial.
In a randomized trial of 803 adults with obesity, those assigned to the high-intensity intervention lost significantly more weight over a 2-year period than patients who received usual care, reported Peter Katzmarzyk, PhD, of Pennington Biomedical Research Center in Baton Rouge, Louisiana, and colleagues.
As shown in their study online in the , those who participated in the intervention lost about 5% of their body weight (95% CI -6.02% to -3.96%), compared with the patients in the usual-care group, who lost only about 0.5% of their body weight (95% CI -1.57% to 0.61%).
Of note, the researchers added, about two-thirds of this primary care population had an annual household income of less than $40,000, nearly 70% of the participants were Black, and about 84% were women.
"We know that intensive lifestyle programs result in weight loss when conducted in academic health centers, but there is a lack of data regarding their effectiveness in real-world settings," Katzmarzyk told 鶹ý.
"Further, most participants in previous studies have been fairly well-off and have had few barriers to participating. We wanted to test the real-world effectiveness of an intensive lifestyle intervention in a diverse population by embedding the program into local primary care clinics to facilitate access," he explained.
Katzmarzyk said he and his colleagues were somewhat surprised by how successful the intervention was: "Our results demonstrated significant weight loss over 2 years which were on par with carefully conducted studies in academic health centers. Given the significant barriers that our population had -- low income, low health literacy, lack of transportation, etc. -- we thought the results would not be as strong."
The key takeaway for healthcare providers, he said, is that "by meeting people where they are, clinically significant weight loss is possible in underserved populations. By culturally adapting effective intervention strategies and embedding them within local communities, there is the potential for people to experience clinically significant weight loss that can be maintained for up to 2 years."
"These results should apply broadly to the large, medically underserved populations that exist in the U.S.," he added.
The cluster-randomized trial was conducted in 18 primary care clinics in Louisiana that primarily served low-income, racially diverse patients. Participants were 20 to 75 years old with body mass index values of 30 to 50. Half the clinics were assigned to deliver the intensive lifestyle program, which involved a combination of in-person and telephone weekly sessions during the initial 6 months followed by monthly sessions for the subsequent 18 months.
The goal of the sessions, which were adapted to the health-literacy level of each patient, was for the individual to achieve a 10% loss in body weight through a reduced-calorie diet and exercise.
In the comparison group, the patients in the other half of the clinics received routine usual care from their primary care provider plus six newsletters on healthy habits.
Subgroup analysis showed that Black patients tended to lose less weight with intensive lifestyle intervention than patients of other races, the researchers noted.
Writing in an , Thomas Wadden, PhD, of the University of Pennsylvania in Philadelphia, and Adam Tsai, MD, MSCE, of the University of Colorado School of Medicine in Aurora, said the trial was well conducted and underscores that socioeconomically disadvantaged persons can in fact achieve "clinically meaningful amounts of weight" through primary care-based intensive behavioral therapy.
"The trial also raises several questions, including the cost of the intervention and whether such care could be effectively disseminated, and potentially at lower expense, by incorporating more telemedicine visits or by using digital platforms that are less reliant on person-to-person counseling," Wadden and Tsai added.
A broader consideration, they said, "is how we can ensure that all Americans, particularly those in underserved communities, receive the same reimbursed care for weight management (including bariatric surgery) that they now do for diabetes, hypertension, and other chronic diseases that often stem from obesity. Lack of such care contributes to the burden of health disparities so apparent in America today."
Disclosures
The study was supported by an award from PCORI, a grant from the National Institute of General Medical Sciences of the National Institutes of Health, which funds the Louisiana Clinical and Translational Science Center, and by a grant from the Nutrition and Obesity Research Center.
Katzmarzyk reported receiving donated supplies from Health and Nutrition Technology and Nutrisystem and grant support paid to Pennington Biomedical Research Center from PCORI; other study authors also reported disclosures.
Wadden and Tsai reported relationships with The Obesity Society, DynaMed, WW (Weight Watchers), and Novo Nordisk.
Primary Source
New England Journal of Medicine
Katzmarzyk P, et al "Weight loss in underserved patients -- a cluster-randomized trial" N Engl J Med 2020; DOI: 10.1056/NEJMoa2007448.
Secondary Source
New England Journal of Medicine
Wadden T, Tsai A "Addressing disparities in the management of obesity in primary care settings" N Engl J Med 2020; DOI: 10.1056/NEJMe2025728.