Table 2

Mean (95% CI) of 12-month follow-up measures for Intervention and Usual Care, by intent-to-treat population and protocol language

InterventionControlBetween-group differenceP value
All study participantsn = 78n = 79
 Weight (pounds)192.2 (181.6, 202.8)201.0 (191.9, 210.2)−8.8 (−22.7, 5.1)0.10
 Weight change (pounds)−2.6 (−5.5, 0.2)−0.56 (−2.7, 1.6)−2.1 (−5.6, 1.4)0.05
 Systolic BP (mmHg)122.5 (119.4, 125.7)122.8 (119.7, 126.0)−0.31 (−4.8, 4.1)0.98
 Change in systolic BP (mmHg)0.35 (−2.8, 3.5)6.4 (3.2, 9.5)−6.0 (−10.5, −1.5)0.01
 HbA1c5.8% (5.8, 5.9) 40 mmol/mol (40, 41)6.1% (5.8, 6.5) 43 mmol/mol (40, 48)−0.31% (−0.61, −0.01) −3.4 mmol/mol (−7.3, −0.1)0.05
 Change in HbA1c (mg/dL)−0.09% (−0.2, −0.0) −1.0 mmol/mol (−2.2, 0.0)0.19% (−0.1, 0.5) 2.1 mmol/mol (−1.1, 5.5)−0.29% (−0.58, 0.01) −3.2 mmol/mol (−6.3, 0.1)0.07
Participants receiving protocol in Englishn = 27n = 45
 Weight (pounds)224.5 (200.7, 248.3)211.4 (199.1, 223.7)13.1 (−10.7, 36.9)0.62
 Weight change (pounds)1.9 (−4.0, 7.9)−0.64 (−3.8, 2.6)2.6 (−3.5, 8.6)0.41
 Systolic BP (mmHg)126.3 (120.6, 132.1)122.7 (118.5, 126.9)3.6 (−3.3, 10.5)0.21
 Change in systolic BP (mmHg)−1.9 (−8.7, 5.0)4.9 (0.5, 9.3)−6.8 (−14.4, 0.9)0.06
 HbA1c5.8% (5.7, 5.9) 40 mmol/mol (39, 41)6.0% (5.8, 6.1) 42 mmol/mol (40, 43)−0.17% (−0.39, 0.05) 1.9 mmol/mol (−4.3, 0.5)0.25
 Change in HbA1c (mg/dL)−0.03% (−0.2, 0.1) 0.3 mmol/mol (−2.2, 1.1)−0.00% (−0.1, 0.1) 0.00 mmol/mol (−1.1, 1.1)−0.03% (−0.19, 0.14) 0.3 mmol/mol (2.1, 1.5)>0.99
Participants receiving protocol in Spanishn = 51n = 34
 Weight (pounds)175.1 (167.8, 182.4)187.3 (174.5, 200.1)−12.2 (−25.7, 1.4)0.29
 Weight change (pounds)−5.1 (−8.0, −2.1)−0.46 (−3.2, 2.3)−4.6 (−8.8, −0.4)<0.01
 Systolic BP (mmHg)120.5 (116.7, 124.3)123.0 (117.9, 128.1)−2.5 (−8.6, 3.7)0.50
 Change in systolic BP (mmHg)1.6 (−1.8, 5.0)8.5 (4.0, 13.1)−7.0 (−12.5, −1.5)0.02
 HbA1c (mg/dL)5.9% (5.8, 6.0) 41 mmol/mol (40, 42)6.4% (5.7, 7.0) 46 mmol/mol (39, 53)−0.50% (−1.00, 0.01) 5.5 mmol/mol (−10.9, 0.1)0.07
 Change in HbA1c (mg/dL)−0.12% (−0.2, 0.0) 1.3 mmol/mol (−2.2, 0.0)0.42% (−0.2, 1.1) 4.6 mmol/mol (−2.2, 12.0)−0.54% (−1.05, −0.03) 5.9 mmol/mol (−11.5, −0.3)0.03
  • BP, blood pressure.