Background We aimed to investigate the overall effectiveness of a comprehensive management mode for overweight/obesity based on mobile internet technology and TCM constitution theory. Methods 40 subjects were enrolled and randomly divided into control group (traditional obesity management mode) and intervention group (comprehensive obesity management mode). The intervention period was 8 weeks, and the follow-up period was 1 year. The information of body indicators, blood indicators and gut microbiota indicators at baseline, 8 weeks and 1 year were collected and analyzed, the primary outcome was the effective weight loss (≥5% body weight loss) rate at 1 year. Results The average age of 40 subjects was 40.3 ± 9.49 years old, with 18 males accounting for 45%. The effective weight loss rate of intervention group was significantly higher than control group (75% vs. 35%; p = 0.025) at 1 year. The body weight (6.88 ± 4.00 vs. 3.08 ± 2.35, p = 0.001), BMI(2.38 ± 1.23 vs. 1.10 ± 0.87, p = 0.001), body fat rate(BFR; 1.8 ± 0.85 vs. 0.82 ± 0.60, p = 0.001), fasting plasma glucose (FPG; 1.08 ± 0.69 vs. 0.49 ± 0.91, p = 0.027), total cholesterol (TC; 1.72 ± 0.60 vs. 0.77 ± 0.57, p = 0.001), Triglyceride (TG; 0.56 ± 0.52 vs. 0.16 ± 0.22, p = 0.003), low density lipoprotein cholesterol (LDL-C; 1.35 ± 0.49 vs. 0.71 ± 0.50, p = 0.001), and diastolic blood pressure (DBP; 1.80 ± 1.96 vs. 0.60 ± 1.57, p = 0.039) decreased more significant in the intervention group. The gut microbiota analysis showed that after intervention, in the intervention group, at phylum level, the Cyanobacteria abundance increased ( p = 0.040), while the Euryarchaeota abundance decreased ( p = 0.045). In addition, the functional abundance of Photosynthesis decreased ( p = 0.008). Conclusion The comprehensive overweight/obesity management mode integrating mHealth with TCM constitution showed more significant long-term weight loss effects. The increase of Cyanobacteria and decrease of Euryarchaeota may be associated with this effect, warranting further investigation. Clinical trial registration https://www.chictr.org.cn/showproj.html?proj=43245 , Identifier, ChiCTR1900025881.
Chen et al. (2026) studied this question.