SAT-105 Weight Loss As Determined By Adherence To Reduced Caloric Diet, Increased Physical Activity, Liraglutide 3.0 Mg and Placebo: A Sub-analysis Of The SCALE IBT Trial

Abstract

Abstract Liraglutide 3.0 mg is approved by the Food and Drug Administration for chronic weight management in the United States as an adjunct to reduced caloric diet and increased physical activity. The objective of the SCALE IBT trial (NCT02963935) was to compare the weight loss for liraglutide 3.0 mg to placebo, both in combination with intensive behavioral therapy (IBT) (i.e. reduced calorie intake, increased physical activity [max target: 250 min/week], and 23 counseling sessions). The present pre-specified exploratory sub-analysis determined the individual contributions of adherence to study medication, and to the adjunct diet and physical activity interventions on weight change. A total of 282 individuals with obesity (BMI ≥30 kg/m2) were randomized to treatment for 56 weeks. Adherence to study medication was recorded on a weekly basis by individuals’ self-reports of taking at least one dose in the preceding week. Adherence to dietary recommendations was assessed via the individuals’ completion of food diaries (at least one entry per day on 5 days or more in the preceding week was considered adherent). Adherence to physical activity recommendations was assessed using electronic activity trackers by comparing measured active minutes to the program goal (starting at 100 min/week increasing to 250 min/week; achieving 50% of target in the preceding week was considered to be adherent). The proportion of randomized individuals who were adherent decreased steadily through the study for all three intervention components. The effect of adherence on body weight was evaluated through an ANOVA model that included dietary information, physical activity and medication adherence and their interaction with randomized treatment. The model was reduced by removing non-significant terms, leaving only the main effect of adherence to diet and physical activity, and the effects of adherence to study medication. As estimated in the final model, adherence to dietary recommendations throughout the trial provided a ‑7.2% reduction in initial body weight (95% CI: -10.4%; -4.0%; p<0.0001); adherence to physical activity recommendations provided -2.0% (95% CI: ‑3.2%; -0.8%; p=0.0009); and adherence to liraglutide 3.0 mg provided an additional loss of -6.5% (95% CI: ‑10.2%; ‑2.9%; p=0.0005). As expected, adherence to placebo did not have a statistically significant effect on weight loss (mean contribution of -1.9%, 95% CI: -5.6%; 1.9%; p=0.33). In conclusion, this sub-analysis indicated that adherence to dietary recommendations and liraglutide injections provided clinically relevant weight loss, whereas the effect of physical activity was more modest in size. Supported by Novo Nordisk.