Behavioral therapy plus medication delivered in primary care proves successful for weight loss
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Combining liraglutide with intensive behavioral therapy at primary care sites led to more weight loss for adults with obesity than behavioral therapy alone, according to findings published in Obesity.
“There’s been a great deal of discussion about what primary care physicians should do to try to help patients with overweight and obesity,” Thomas A. Wadden, PhD, professor of psychology in the department of psychiatry at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, told Healio. “The study comes on the heels of the Centers for Medicare and Medicaid Services saying we’re going to now pay for treatment for people who are Medicare beneficiaries, and there’s been very little guidance about how to care for patients.”
Weight loss with counseling plus medication
Wadden and colleagues assessed body weight at baseline and at 56 weeks among 282 adults with obesity from 17 primary care sites. The researchers randomly assigned a daily 3 mg injection of liraglutide (Saxenda, Novo Nordisk) to 142 participants (mean age, 45.4 years; 83.8% women) and a placebo regimen to 140 participants (mean age, 49 years; 82.9% women).
All participants received intensive behavioral therapy that adhered to Centers for Medicare and Medicaid Services (CMS) requirements. This therapy, which Wadden noted was adapted from the Diabetes Prevention Program, ultimately required participants to log 250 minutes of moderate-intensity physical activity per week with diets ranging from 1,200 kcal to 1,800 kcal per day depending on baseline body weight. The therapy also included 23 15-minute counseling sessions with a dietitian who worked “incident to” a primary care provider.
“The biggest surprise is how well both the dietitians and the participants did,” Wadden said. “Fifteen minutes is a very brief period for a visit, and having visits eventually every other week is not a whole lot of time to work on weight control.”
The researchers assessed body weight at baseline and 16, 28 and 56 weeks, with measures of waist circumference, HbA1c and fasting plasma glucose taken at baseline and 56 weeks as well.
Participants who received liraglutide 3.0 mg lost a mean of 7.5% of their baseline weight at 56 weeks, which was 3.4 percentage points greater than those assigned to placebo (P = .0003). Among those assigned liraglutide, 61.5% lost at least 5% at 56 weeks while 38.8% of those who received behavioral therapy alone met this threshold (P = .0003). It was more than twice as likely that participants assigned liraglutide would lose at least 5% of baseline body weight than it was for participants assigned placebo (OR = 2.5; 95% CI, 1.5-4.1). Participants assigned liraglutide were also more likely to lose more than 10% of baseline body weight (OR = 1.8; 95% CI, 1-3.1) and more than 15% of baseline body weight (OR = 2.3; 95% CI, 1.1-4.7) compared with those assigned placebo.
“I think these two approaches — intensive behavioral therapy and medication — have complementary mechanisms of action. Intensive behavioral therapy helps patients cope with the external food environment by consciously keeping high-calorie foods out of the house, avoiding venues that serve them — particularly in large portion sizes — and by recording food intake daily,” Wadden said. “Liraglutide 3.0 mg appears to reduce patients’ hunger and food preoccupation, so they are less inclined to initiate eating, even when exposed to high-calorie foods.”
Improvements beyond weight loss
In addition, participants assigned liraglutide decreased waist circumference by 9.4 cm at 56 weeks while those assigned placebo decreased waist circumference by 6.7 cm (P = .0063). Participants assigned liraglutide also decreased HbA1c by 0.2% while those assigned placebo decreased HbA1c by 0.1% (P = .0008). Lastly, participants assigned liraglutide decreased FPG by 0.2 mmol/L while those assigned placebo decreased FPG by 0.01 mmol/L (P = .0002).
"Many patients lost enough weight to improve their health, including glucose control, blood pressure and other cardiometabolic risk factors," Wadden said.
Although the study showed that combining liraglutide with the intensive behavioral therapy led to more weight loss than the behavioral therapy alone, Wadden noted that the weight loss from the behavioral therapy by itself was still “a very positive finding.”
The next step is for CMS to expand the scope of health care providers who can provide this type of treatment to include independent dietitians, Wadden said. CMS approves the treatment only from physicians, nurse practitioners, nurse specialists, physician assistants and other providers who bill “incident to” a primary care provider.
“The real question is: Can the CMS allow a greater range of practitioners to provide this care?” Wadden said. "Optimally we want to make intensive behavioral therapy for obesity more accessible by having the option of its being delivered by practitioners who are not as busy or as expensive as physicians and nurse practitioners." – by Phil Neuffer
For more information:
Thomas A. Wadden, PhD, can be reached at wadden@pennmedicine.upenn.edu.
Disclosure: Novo Nordisk sponsored the study. Wadden reports he received grants from and served on the scientific advisory boards for Novo Nordisk and Weight Watchers.
Perspective
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Ken Fujioka, MD
This is an exceptionally well done study, as a retention rate of 96% in the best I have ever seen. This real-world study also helps clinicians understand that if patients lose 4% of their body weight in 16 weeks, they will go on to do well and the average weight loss will be higher, probably with an average of more than 10% in program completers who lose that 4% in 16 weeks.
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Wadden TA, et al. Obesity. 2020;doi:10.1002/oby.22726.
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