Investigators find intensive behavior therapy results in weight loss, even in the placebo-controlled group.
Thomas A. Wadden, PhD
Intensive behavior therapy (IBT) can produce substantial weight loss in obese individuals, especially if it is done in conjunction with liraglutide, according to a new study.
An investigative team, led by Thomas A. Wadden, PhD, Department of Psychiatry at the Perelman School of Medicine at the University of Pennsylvania, conducted a multi-site study evaluating in primary care for the first time the effect of the Centers for Medicare and Medicaid Services-based IBT benefit delivered alone or in combination of 3 mg of liraglutide.
In the Satiety and Clinical Adiposity—Liraglutide Evidence (SCALE) study the investigators examined patients with and without diabetes for 56-weeks. In the randomized, double-blind, placebo-controlled, multicenter trial, individuals with obesity received liraglutide (n = 142) or placebo (n = 140) as an adjunct to intensive behavior therapy.
The investigators sought a coprimary end point of the change in body weight (percentage) from baseline to week 56 and the proportion of participants who lost ≥ 5% of baseline body weight.
They also sought secondary confirmatory end points including the proportion of patients who lost > 10% or > 15% of baseline body weight at week 56 and the proportion who lost ≥ 4% of baseline body weight at week 16 because the US label for liraglutide recommends discontinuing treatment if an individual does not lose ≥ 4% of baseline body weight by week 16.
The team also sought other secondary confirmatory end points in the changes from baseline to week 56 in waist circumference and in self-reported quality of life related to physical function, measured by the by the Short Form‐36 v2 Health Survey (Acute Version 2.0 [SF‐36]) physical functioning score and by the physical function scale of the Impact of Weight on Quality of Life‐Lite Clinical Trial version (IWQOL‐Lite‐CT).
Changes in objective physical capacity was measured by a 6-minute walk test (6MWT).
The investigators sought supportive secondary end points including the change from baseline to week 56 in cardiometabolic parameters (HbA1c, fasting plasma glucose, systolic and diastolic blood pressure, and lipids).
After week 56, the mean weight loss with the combination therapy was 7.5%, while the placebo-controlled group had a mean weight loss of 4.0% (95% CI, —5.3 to –1.6%; P = 0.0003).
The investigators found significantly more individuals on liraglutide than the placebo achieved ≥ 5% weight loss (61.5% vs. 38.8%; OR, 2.5% [1.5-4.1%]; P = 0.0003), > 10% weight loss (30.5% vs. 19.8%; OR, 1.8% [1.0-3.1%]; P = 0.0469), and > 15% weight loss (18.1% vs. 8.9%; OR, 2.3% [1.1-4.7%]; P = 0.0311).
IBT in combination with the placebo produced clinically meaningful weight loss after 56 weeks in nearly 40% of the participants. However, the weight loss was significantly enhanced with the addition of liraglutide.
Liraglutide was also well tolerated, with no new safety signals identified.
“In a primary care setting, Centers for Medicare and Medicaid Services—based IBT produced clinically meaningful weight loss at 56 weeks, enhanced by the addition of liraglutide 3.0 mg,” the authors wrote.
The investigators said the study could raise questions concerning to which extent high-intensity behavioral counseling contributes to additional weight loss with weight loss medication when compared to less intensive lifestyle intervention.
The study, “Liraglutide 3.0 mg and Intensive Behavioral Therapy (IBT) for Obesity in Primary Care: The SCALE IBT Randomized Controlled Trial,” was published online in Obesity.