This study was reviewed and approved by the Ethics Committee of the Shanghai Pudong New Area Beicai Community Health Service Center (approval no. 20250425AR; approved April 25, 2025). All participants provided written informed consent prior to inclusion.
Research design and study population
This cross-sectional study aimed to identify objective indicators associated with the dampness constitutions (Phlegm-Dampness and Damp-Heat) using BIA. Participants were recruited from a community-based health screening program conducted at the Beicai Community Health Service Center (Pudong New Area, Shanghai) between July 1, 2025, and January 5, 2026. All individuals who completed both the TCM constitution assessment and the BIA measurement during this period were enrolled consecutively. Participants with missing data on any key variable were excluded. A total of 232 participants were ultimately included, comprising 129 in the Harmonious constitution group and 103 in the dampness constitution group.
Diagnostic criteria for dampness constitution
Constitution assessment was carried out using a patented portable smart mirror for traditional Chinese medicine (TCM) constitution analysis (Hi-Face22; Chinese utility model patent No. ZL 2021 2 1286496.5), which applies the standardized nine-constitution classification framework of TCM and generates a quantified constitution diagnosis from facial features and built-in questionnaire responses. Participants identified as having the phlegm-damp or damp-heat constitution as the predominant type were included in the dampness constitution group; those meeting the criteria for the harmonious constitution and showing no other constitutional imbalance were included in the control group2. To our knowledge, peer-reviewed validation of this device against an independent reference standard (e.g., expert TCM assessment or a validated questionnaire) has not been published; this is acknowledged as a limitation.
BIA and body composition measurement
BIA measurements were performed using a multifrequency, eight-point tactile electrode segmental bioelectrical impedance analyzer (InBody 770, see Table of Materials), in strict accordance with the manufacturer's standard operating procedures. The device applies alternating currents at multiple frequencies (1, 5, 50, 250, 500, and 1,000 kHz) and is phase-sensitive, directly measuring resistance (R), reactance (Xc), and phase angle (PhA) for the whole body and five segments (right arm, left arm, trunk, right leg, left leg) via tetrapolar electrode configurations. Trunk resistance, reactance, and phase angle were measured between the right hand and right foot electrodes and recorded at 50 kHz. It should be noted that BIA devices directly measure bioelectrical parameters that are affected by body fluid and electrolyte status; the reported fluid volumes and body composition values are estimates derived from the device's prediction equations. Prior to measurement, subjects were required to fast for at least 2 h, avoid strenuous exercise for 12 h, and empty their bladders. During measurement, subjects stood barefoot on the foot electrodes and held the hand electrodes with both hands. The following body composition parameters were recorded: Total Body Water (TBW), Intracellular Water (ICW), Extracellular Water (ECW), ECW/TBW ratio (numerical value and percentage), TBW/Fat-Free Mass (TBW/FFM) ratio, Percentage of Body Fat (PBF), Body Fat Mass (BFM), Visceral Fat Area (VFA), Fat Mass Index (FMI), Obesity level, Skeletal muscle mass (SMM), Lean body mass (SLM), Fat-free mass (FFM), Body cell mass (BCM), Protein, Upper arm circumference (AMC), Basal metabolic rate (BMR). The following segmental bioelectrical parameters were recorded: Whole-body phase angle (PA_Whole), right upper limb phase angle (PA_RA), left upper limb phase angle (PA_LA), trunk phase angle (PA_TR), right lower limb phase angle (PA_RL), left lower limb phase angle (PA_LL), trunk impedance (Impedance_TR), trunk reactance (Reactance_TR). Simultaneously, the following anthropometric parameters were measured: height, weight, Body Mass Index (BMI), waist-to-hip ratio (WHR), abdominal circumference, and left and right calf circumferences.
Grip strength measurement
Grip strength was measured with a digital handgrip dynamometer (see Table of Materials). After two maximum isometric contractions on each hand, alternating between the left and right hands with a one-minute rest between contractions, the mean of the two trials of the dominant hand was calculated and used for analysis (Mean_Grip)
Statistical analysis
The overall analytical framework LASSO-based feature screening followed by multivariable logistic regression, with sex-stratified and sensitivity analyses) was defined a priori. However, the specific features entering the final model were determined by data-driven LASSO selection, and the sex-stratified and sensitivity analyses should be regarded as exploratory. No missing values were present for any of the variables included in the analysis. Continuous variables that followed a normal distribution were expressed as mean ± standard deviation; those that did not follow a normal distribution were expressed as median (interquartile range); categorical variables were expressed as frequency (percentage). Comparisons between groups were performed using the independent samples t-test, the Mann-Whitney U test, or the chi-squared test, with P < 0.05 considered statistically significant.
Subsequently, BIA features were screened using LASSO regression; the optimal penalty parameter λ was determined via 10-fold cross-validation, and features with non-zero coefficients at the λ that minimized the cross-validation error (λ.min) were selected. The model's discriminatory power was assessed using the area under the receiver operating characteristic curve (AUC). The 10-fold cross-validation procedure was used solely to select the LASSO penalty parameter λ and did not serve as validation of the final model; internal validation of the final model was performed using bootstrap optimism correction (1,000 resamples) and 5-fold cross-validation, and multicollinearity was assessed using the variance inflation factor (VIF), with values below five considered acceptable. Model calibration was assessed using the Hosmer–Lemeshow goodness-of-fit test and the bootstrap-corrected calibration slope. The clinical net benefit was evaluated using decision curve analysis (DCA). DCA was performed over the full threshold probability range of 0–1.0, with net benefit expressed relative to the 'treat all' and 'treat none' reference strategies. The clinical decision scenario was whether to recommend further assessment or intervention for the dampness constitution among community screening participants.
Subsequently, the features identified via LASSO screening, along with age and sex, were incorporated into a multivariable logistic regression model to assess the independent association of each indicator with the dampness constitution, yielding odds ratios (ORs) and 95% confidence intervals (CIs).
Subgroup analyses were conducted by sex to assess the stability of the associations. Sensitivity analyses included: (1) applying 1% and 99% Winsorization to continuous variables; and (2) additional adjustment for waist-to-hip ratio or abdominal circumference. All statistical analyses were performed using R version 4.5.2.