Table 3.
Within-participant change in body weight, in kg, during each treatment block, accounting for baseline weight at the beginning of each treatment block, testing potential explanatory covariates in each statistical model
| Factor | Model 1 (N = 13) | Model 2 (N = 13) | Model 3 (N = 13) | Model 4 (N = 13) |
|---|---|---|---|---|
| β coefficient (95% CI) |
β coefficient (95% CI) |
β coefficient (95% CI) |
β coefficient (95% CI) |
|
| Treatment (OXT, reference = PBO) | −0.6 (−2.7, 1.5) |
−0.6 (−2.7, 1.5) |
−0.6 (−2.7, 1.5) |
−0.6 (−3.1, 1.8) |
| Block in study (Block 2, reference = Block 1) | −1.4 (−3.5, 0.8) |
−1.4 (−3.5, 0.7) |
−1.4 (−3.4, 0.7) |
−1.3 (−3.7, 1) |
| Weight at beginning of each treatment block, kg | 0 (−0.1, 0) |
0 (−0.1, 0.1) |
0 (−0.1, 0.0) |
0 (−0.1, 0.1) |
| Age, years | - | −0.1 (−0.4, 0.2) |
- | - |
| Sex, (female, reference = male) | - | - | −1.2 (−3.6, 1.2) |
- |
| Adherence to study drug (% of all prescribed doses taken) | - | - | - | 0 (−0.1, 0.1) |
Main model (Model 1) and sensitivity analyses (Models 2-4) of prespecified primary outcome, change in body weight (kg), are shown. To test for possible carry-over effect, an interaction term between treatment (OXT vs PBO) and block (1 vs 2) was included in the main model (Model 1), and the interaction term was not statistically significant (not shown), so models are presented without this interaction term. None of the β coefficients shown above was statistically significant.
Abbreviations: OXT, oxytocin; PBO, placebo.