Table 2.

Estimated mean changes in clinical outcomes over 24 Months in the Intention-to-treat population of Vivamos Activos Fair Oaks Study using Generalized Estimating Equations (GEE) and multiple imputation to account for missing data (n=207).

	CMa (n=84)	CM+CHWb (n=82)	UCc (n=41)		p values
Change in Outcome Measures	Mean (95% CI)	Mean (95% CI)	Mean (95% CI)	CM vs. UC	CM+ CHW vs.UC	CM+ CHW vs. CM
Weight (kg)
6 months	−1.6 (−2.4, −0.7)	−2.1 (−2.8, −1.3)	−0.9 (−1.9, 0.1)	0.28	0.05	0.65
12 months	−1.4 (−2.4, −0.3)	−1.9 (−2.9, −0.9)	−0.7 (−2.2, 0.8)	0.49	0.21	0.76
24 months	−1.0 (−2.4, 1.0)	−1.0 (−2.4, 0.4)	−0.6 (−2.8, 1.5)	0.78	0.76	0.98
BMI
6 months	−0.6 (−1.0, −0.3)	−0.8 (−1.1, −0.5)	−0.4 (−0.7, 0.0)	0.27	0.07	0.49
12 months	−0.6 (−1.0, −0.1)	−0.7 (−1.1, −0.3)	−0.3 (−0.8, 0.3)	0.39	0.20	0.60
24 months	−0.4 (−1.0, 0.2)	−0.4 (−0.9, 0.2)	−0.2 (−1.1, 0.7)	0.67	0.72	0.93
Percentage Weight Change (%)
6 months	−0.02 (−0.02, −0.01)	−0.02 (−0.03, −0.01)	−0.01 (−0.02, 0)	0.50	0.24	0.54
12 months	−0.01 (−0.03, 0)	−0.02 (−0.04, −0.01)	−0.01 (−0.03, 0.01)	0.96	0.92	0.95
24 months	−0.01 (−0.02, 0.01)	−0.02 (−0.03, 0)	0 (−0.03, 0.02)	0.92	0.72	0.76
Waist circumference
6 months	−0.7 (−1.3, −0.2)	−0.6 (−1, −0.2)	0.0 (−0.7, 0.7)	0.11	0.14	0.89
12 months	−1.5 (−2.2, −0.8)	−0.6 (−1.4, 0.2)	−1.3 (−2.2, −0.4)	0.76	0.26	0.36
24 months	−1.4 (−2.1, −0.7)	−0.8 (−1.5, −0.1)	−0.7 (−1.7, 0.2)	0.24	0.95	0.52
Systolic BP
6 months	−0.1 (−2.9, 2.7)	−1.8 (−4.2, 0.6)	−2.2 (−6.4, 2)	0.41	0.87	0.71
12 months	−2.2 (−5.1, 0.6)	−1.3 (−4.3, 1.6)	−3.0 (−7.8, 1.7)	0.77	0.57	0.86
24 months	0.6 (−2.3, 3.5)	0.5 (−2.9, 3.8)	−0.2 (−4.3, 3.8)	0.74	0.79	0.98
Diastolic BP
6 months	−0.1 (−1.5, 1.3)	−0.2 (−1.6, 1.2)	0.3 (−1.9, 2.6)	0.73	0.72	0.98
12 months	−0.6 (−2.3, 1.1)	0.3 (−1.7, 2.2)	−1.3 (−4.1, 1.5)	0.62	0.40	0.78
24 months	1.2 (−0.5, 2.9)	0.9 (−0.9, 2.7)	−0.2 (−2.2, 1.8)	0.33	0.46	0.90
Total Cholesterol
6 months	1.7 (−4.6, 7.9)	−0.6 (−10.2, 9.1)	2.8 (−7.6, 13.2)	0.86	0.64	0.85
12 months	1.8 (−5.2, 8.8)	8.7 (1.2, 16.2)	1.5 (−9.3, 12.3)	0.96	0.30	0.55
24 months	7.0 (−1.8, 15.8)	10.8 (0.7, 20.8)	5.6 (−4.5, 15.6)	0.82	0.48	0.76
Fasting Blood Glucose
6 months	0.7 (−5.9, 7.2)	0.4 (−5.4, 6.2)	4.0 (−3.7, 11.7)	0.52	0.47	0.98
12 months	−1.6 (−9.8, 6.7)	−2.9 (−8.8, 3.0)	6.3 (−1.5, 14.1)	0.18	0.07	0.88
24 months	2.7 (−8.5, 13.9)	−1.9 (−11.9, 8.2)	4.6 (−6.3, 15.5)	0.81	0.34	0.72
Hemoglobin A1C
6 months	0.0 (−0.1, 0.2)	−0.2 (−0.4, 0.0)	−0.1 (−0.3, 0.1)	0.30	0.50	0.33
12 months	0.0 (−0.2, 0.2)	−0.2 (−0.5, 0.0)	−0.1 (−0.5, 0.3)	0.57	0.73	0.61
24 months	−0.1 (−0.3, 0.2)	−0.3 (−0.6, −0.1)	−0.3 (−0.5, 0.0)	0.19	0.75	0.33
HDL Cholesterol
6 months	−1.4 (−3.3, 0.5)	−0.4 (−1.8, 1.1)	0.0 (−1.6, 1.6)	0.29	0.76	0.61
12 months	0.6 (−1.9, 3.1)	1.6 (−0.8, 4.0)	1.7 (−1.2, 4.5)	0.59	0.98	0.75
24 months	−0.2 (−3.7, 3.3)	0.3 (−3.2, 3.8)	1.4 (−1.4, 4.3)	0.46	0.62	0.89
LDL Cholesterol
6 months	16.3 (−6.4, 39)	5.5 (−5.6, 16.6)	12.9 (0.6, 25.3)	0.79	0.39	0.54
12 months	2.9 (−2.9, 8.7)	4.0 (−2.6, 10.7)	1.9 (−7.3, 11.1)	0.86	0.72	0.91
24 months	5.8 (−1.3, 12.8)	4.8 (−3.8, 13.4)	4.0 (−6.5, 14.4)	0.77	0.91	0.93
Trigylcerides
6 months	−7.4 (−30.5, 15.7)	−3.2 (−19.4, 13.0)	−17.2 (−38.1, 3.7)	0.53	0.29	0.87
12 months	−12.3 (−37.2, 12.6)	1.5 (−14.0, 17.0)	−19.0 (−40.8, 2.8)	0.69	0.13	0.58
24 months	5.0 (−25.5, 35.5)	15.1 (−14.4, 44.6)	−1.3 (−36.8, 34.2)	0.79	0.48	0.80
C-Reactive Protein (not measured at 6 months)
At 12 months	0.1 (0.0, 0.2)	0.0 (−0.2, 0.2)	0.2 (−0.1, 0.5)	0.51	0.35	0.54
At 24 months	0.1 (0.0, 0.3)	0.0 (−0.2, 0.1)	0.3 (0.0, 0.7)	0.32	0.07	0.12

* Significance at p < 0.05,

** Significance at p < 0.01,

*** Significance at p < 0.001

^aCM = Case Management arm

^bCM+CHW = Case Management plus Community Health Worker arm

^cUC = Usual Care Control arm