Adults with obesity seen in primary care lost more weight with a combination of the GLP-1 receptor agonist liraglutide and intensive behavioral therapy (IBT) than with behavioral therapy alone.
A previous year-long open-label trial at a single site assessed the efficacy of CMS-based IBT alone vs IBT plus liraglutide in an obesity specialty setting. Results of that study support the efficacy of IBT for obesity and the potential benefit of adding medical therapy to this approach.
In the present study, researchers led by 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, enrolled 282 adults with obesity from 17 primary care sites.
Eligibility: age ≥ 18 years, with stable body weight (maximum 5‐kg self‐
reported weightchange within 90 days before screening) and BMI ≥ 30 kg/m2.
Key exclusion criteria included A1c ≥ 6.5%,type 1 or 2 diabetes, use
of medications (in the past 90 days) known to induce significant weight loss
or gain, inadequately treated hypertension, and history of cardiovascular disease.
A daily injection of liraglutide 3.0 mg was randomly assigned 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 were monitored at clinic visits for response to treatment and received 23 brief (15-min) CMS-based IBT counseling sessions:
- Weekly during month 1
- Bi-weekly during months 2 to 6
- Monthly from months 7-13 (regardless of meeting CMS-required ≥3 kg during first 6 months)
The CMS-based IBT program reflects “an abbreviated lifestyle counseling protocol" adapted from the Diabetes Prevention Program (DPP) for delivery in primary care:
- 250 mins moderate-intensity physical activity per week (gradual increase from 100 min/week)
- Diets ranging from 1,200 or 1800 calories/day depending on baseline body weight.
- 23 15-minute counseling sessions with a dietitian who worked “incident to” a primary care provider.
Participant body weight was assessed at baseline, 16, 28 and 56 weeks; measures of waist circumference, A1c, and fasting plasma glucose (FPG) were taken at baseline and 56 weeks.
RESULTS - please click below for next page