. 2022 Aug 8;182(9):953–962. doi: 10.1001/jamainternmed.2022.3050

Table 2. Body Composition and Cardiometabolic Risk Factors.

Outcome	Change in the CON+ER group (n = 45)^a		Change in the eTRE+ER group (n = 45)^a		Difference between groups^b
Outcome	Mean (95% CI)	P value	Mean (95% CI)	P value	Mean (95% CI)	P value	Cohen d
Weight, kg^c	−4.0 (−5.1 to −2.9)	<.001	−6.3 (−7.4 to −5.2)	<.001	−2.3 (−3.7 to −0.9)	.002	.33^d
Weight loss, %^c	−4.2 (−5.3 to −3.2)	<.001	−5.7 (−6.7 to −4.7)	<.001	−1.5 (−2.7 to −0.2)	.02	.25^d
Fat loss:weight loss, %^e	78.2 (71.4 to 85.0)	NA	74.0 (65.3 to 82.7)	NA	−4.2 (−14.9 to 6.5)	.43	.23
Fat mass, kg	−3.4 (−4.6 to −2.2)	<.001	−4.7 (−5.7 to −3.7)	<.001	−1.4 (−2.9 to 0.2)	.09	.34
Fat-free mass, kg	−1.3 (−1.9 to −0.7)	<.001	−1.5 (−2.1 to −0.9)	<.001	−0.1 (−0.9 to 0.7)	.75	.06
Trunk fat, kg	−1.9 (−2.5 to −1.3)	<.001	−2.8 (−3.4 to −2.2)	<.001	−0.9 (−1.8 to 0.1)	.07	.39
Visceral fat, kg^f	−0.2 (−0.4 to −0.1)	.002	−0.3 (−0.5 to −0.1)	<.001	−0.1 (−0.2 to 0.1)	.37	.22
Waist circumference, cm	−4.1 (−5.9 to −2.3)	<.001	−5.3 (−7.1 to −3.5)	<.001	−1.5 (−3.9 to 0.9)	.23	.20
Appendicular lean mass, kg	−0.8 (−1.2 to −0.4)	<.001	−0.9 (−1.3 to −0.5)	<.001	−0.1 (−0.6 to 0.5)	.78	.07
Blood pressure, mm Hg
Systolic	−3 (−7 to 1)	.07	−8 (−12 to −4)	<.001	−4 (−9 to 1)	.09	.32
Diastolic	−1 (−3 to 1)	.37	−5 (−7 to −3)	<.001	−4 (−8 to 0)	.04	.45
Heart rate, bpm^g	−3 (−7 to 1)	.10	−5 (−9 to −1)	.01	−1 (−6 to 3)	.55	.15
Glucose, mg/dL	−6 (−10 to −2)	.01	−8 (−12 to −4)	<.001	−2 (−9 to 5)	.53	.13
Insulin, µIU/mL^g	−1.8 (−6.4 to 2.8)	.44	−6.4 (−10.8 to −2.0)	.006	−4.2 (−10.7 to 2.2)	.20	.30
HOMA-IR^g	−0.74 (−2.02 to 0.54)	.25	−2.00 (−3.24 to −0.76)	.002	−1.10 (−2.90 to 0.70)	.23	.30
HOMA-β^g	11 (−45 to 67)	.69	−46 (−102 to 10)	.10	−57 (−137 to 22)	.16	.31
HbA_1c, %	−0.1 (−0.3 to 0.1)	.24	−0.1 (−0.3 to 0.1)	.31	0.0 (−0.2 to 0.2)	.98	.01
Cholesterol, mg/dL
Total	−15 (−27 to −3)	.02	−9 (−21 to 3)	.15	6 (−10 to 22)	.48	.15
LDL	−9 (−17 to −1)	.04	−5 (−13 to 3)	.30	5 (−8 to 18)	.45	.15
HDL	−4 (−8 to 0)	.02	−4 (−6 to −2)	.01	0 (−4 to 4)	.96	.01
Triglycerides, mg/dL	−9 (−27 to 9)	.32	−3 (−21 to 15)	.78	6 (−17 to 30)	.61	.10

Abbreviations: BMI, body mass index, calculated as weight in kilograms divided by height in meters squared; CON+ER, control eating schedule plus energy restriction; eTRE+ER, early time-restricted eating plus energy restriction; HbA_1c, hemoglobin A_1c; HDL, high-density lipoprotein; HOMA-β, Homeostasis Model Assessment for β-cell Function, calculated as 360 × insulin/[glucose – 63], where the unit of measure for insulin is µIU/mL and the unit of measure for glucose is mg/dL; HOMA-IR, Homeostasis Model Assessment for Insulin Resistance, calculated as insulin × glucose/405, where the unit of measure for insulin is µIU/mL and the unit of measure for glucose is mg/dL; LDL, low-density lipoprotein; NA, not applicable.

SI conversion factors: To convert cholesterol mg/dL to mmol/L, multiply by 0.0259; glucose mg/dL to mmol/L, multiply by 0.0555; insulin µIU/mL to pmol/L, multiply by 6.945; triglycerides mg/dL to mmol/L, multiply by 0.0113.

^{^a}

Within-group changes were unadjusted and were based 90 observations at week 0 and 59 observations at week 14, respectively, except where otherwise noted.

^{^b}

Between-group differences were adjusted for sex, race, and age and were based on 90 observations at week 0 and 59 observations at week 14, respectively, except where otherwise noted.

^{^c}

For body weight, there were 90, 61, 69, 56, 60, 50, 48, and 59 observations at weeks 0, 2, 4, 6, 8, 10, 12, and 14, respectively.

^{^d}

Since there is no well-established method for calculating Cohen d from linear mixed models, we calculated the unadjusted Cohen d values using only week 0 and 14 data.

^{^e}

For the ratio of fat loss to weight loss, there were 41 observations. See eMethods in Supplement 1.

^{^f}

For visceral fat, there were 73 observations at week 0 and 47 at week 14. See eMethods in Supplement 1.

^{^g}

One baseline value was excluded. See eMethods in Supplement 1.