Table 2. Primary, Secondary, and Exploratory Outcomes From Baseline to 12 Months for Intermittent vs Continuous Groups (Intention-to-Treat Analysis)a.
Variable | Mean (SEM) [95% CI] | P Value for Time | Mean (SEM) [95% CI] | P Value for Diet by Time | |
---|---|---|---|---|---|
Continuous Restriction Group | Intermittent Restriction Group | ||||
Primary outcome | |||||
HbA1c, % | −0.4 (0.1) [−0.6 to −0.2] | <.001 | −0.5 (0.2) [−0.8 to −0.2] | −0.3 (0.1) [−0.6 to −0.08] | .65 |
Secondary outcomes | |||||
Weight, kg | −5.9 (0.6) [−7.1 to −4.8] | <.001 | −5.0 (0.8) [−6.6 to −3.5] | −6.8 (0.8) [−8.5 to −5.1] | .25 |
BMI | −2.1 (0.2) [−2.5 to −1.7] | <.001 | −1.9 (0.3) [−2.4 to −1.3] | −2.3 (0.3) [−2.9 to −1.7] | .43 |
Total body fat, %b | −1.8 (0.4) [−2.5 to −1.1] | <.001 | −1.6 (0.3) [−2.2 to −0.9] | −2.3 (0.6) [−3.5 to −1.1] | .20 |
Total fat mass, kgb | −4.1 (0.5) [−5.0 to −3.2] | <.001 | −3.4 (0.6) [−4.6 to −2.2] | −4.7 (0.7) [−6.1 to −3.4] | .20 |
Total fat-free mass, kgb | −1.8 (0.3) [−2.4 to −1.3] | <.001 | −1.6 (0.4) [−2.3 to −0.8] | −2.1 (0.4) [−2.9 to −1.4] | .11 |
Android fat, %b,c | −3.8 (1.1) [−5.9 to −1.7] | <.001 | −2.0 (1.2) [−4.4 to −0.5] | −5.6 (1.7) [−9.0 to −2.1] | .23 |
Android fat mass, kgb | −0.8 (0.2) [−1.2 to −0.5] | <.001 | −0.6 (0.2) [−1.1 to −0.2] | −1.1 (0.2) [−1.5 to −0.6] | .37 |
Android fat-free mass, kgb | −0.3 (0.1) [−0.5 to −0.04] | .05 | −0.3 (0.2) [−0.6 to −0.02] | −0.3 (0.2) [−0.6 to −0.08] | .75 |
VAT, kgb | −0.2 (0.06) [−0.3 to −0.1] | <.001 | −0.2 (0.09) [−0.4 to −0.02] | −0.2 (0.09) [−0.4 to −0.08] | .42 |
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); HbA1c, hemoglobin A1c; VAT, visceral adipose tissue.
SI conversion factor: To convert HbA1c to proportion of total hemoglobin, multiply by 0.01.
Data were included for 137 participants (67 in the continuous energy restriction group and 70 in the intermittent energy restriction group) unless otherwise stated: mean (SEM) and 95% CI were estimated using an intention-to-treat analysis with a linear mixed model.
For a total of 128 participants (64 in the continuous energy restriction group and 64 in the intermittent energy restriction group) with weight greater than 130 kg or who declined dual-energy x-ray absorptiometry scan.
Percentage fat of tissue in the android region.