Exploratory Machine Learning Methods to Assess a Novel Individualized Lifestyle Intervention on Weight and Body Composition with or Without a Swallowable Intragastric Balloon

Abstract

Background/Objectives: This study assesses the effects of an individualized lifestyle intervention (LI) on body composition (BC), both with and without the addition of the Allurion™ swallowable intragastric balloon (SIGB). Methods: In this case-controlled study, a total of 1,143 patients with a BMI ≥ 30 kg/m2 participated in a 36-week LI. Of these, 267 received the SIGB (LI + SIGB group), while 876 underwent the LI alone (LI group). The LI protocol featured personalized nutritional plans with daily protein intake goals, exercise goals, and regular telehealth follow-ups. The SIGB was ingested without endoscopy or anesthesia and passed naturally approximately 16 weeks post-placement. Body composition was assessed using bioimpedance at multiple time points. We compared percent total body weight loss (%TBWL), fat mass loss (%FML), muscle mass loss (%MML), and visceral fat loss (%VFL) between the groups. Results: The groups were age-matched but differed in sex and BMI. At 16 weeks, the LI + SIGB group demonstrated significantly higher mean %TBWL (16.11 ± 5.06 vs. 10.22 ± 6.09, p < 0.001), %FML (27.64 ± 9.78 vs. 15.34 ± 10.37, p < 0.001), and %VFL (17.60 ± 7.33 vs. 13.80 ± 8.57, p < 0.001). While %MML was also higher in the LI + SIGB group (6.57 ± 7.64 vs. 3.55 ± 12.45, p < 0.001), the rate of %FML was more than double the rate of %MML in both groups, suggesting favorable body composition changes. A significantly greater proportion of patients in the LI + SIGB group achieved key weight loss thresholds of > 5%, > 10%, and > 20% TBWL at 16 weeks (all p < 0.001). Conclusions: The SIGB significantly enhanced total body weight loss, fat loss, and visceral fat loss when used as an adjunct to an intensive lifestyle intervention. While the SIGB did lead to greater muscle mass loss, the overall body composition changes were favorable, with fat loss far outpacing muscle loss in both intervention groups. These findings suggest that the SIGB is a safe and effective tool to accelerate early weight loss, particularly fat loss, when combined with a robust lifestyle protocol.