Measure/OutcomeOptifast Program(N=135)Food-Based Program(N=138)
Age in years, mean (SD)47.0 (11.2)47.2 (11.3)
Sex, n (%)
Female116 (85.9)109 (79.0)
Race, n (%)
Caucasian100 (74.1)95 (68.8)
African American22 (16.3)37 (26.8)
Asian/Pacific Islander4 (3.0)2 (1.4)
Hispanic5 (3.7)4 (2.9)
Other4 (3.0)0
Baseline characteristics
Weight in kg, Mean (SD)106.8 (20.8)109.9 (23.2)
BMI in kg/m2, Mean (SD)38.4 (5.5)39.2 (6.2)
Weight change*, % of initial body weight, Mean (SD)Difference (p value)
26 week follow up12.2 (0.6)5.9 (0.6)6.2 (p<0.01)
52 week follow up10.3 (0.6)5.5 (0.6)4.8 (p<0.01)
HbA1c change* (%), Mean (SD)
Baseline5.7 (0.8)5.7 (0.7)
26 week follow up5.5 (0.5)5.6 (0.6)-0.1 (p=0.08)
52 week follow up5.5 (0.9)5.7 (1.0)-0.1 (p=0.04)
Fasting blood glucose change* (mmol/L), Mean (SD)
Baseline5.6 (1.5)5.6 (1.2)
26 week follow up5.2 (0.9)5.5 (1.2)-0.3 (p=0.02)
52 week follow up5.4 (1.8)5.7 (1.9)-0.2 (p=0.11)
Diabetes status = Yes** in mITT*** population
26 week follow up10/17 (58.8)18/25 (72.0)p=0.07
52 week follow up11/17 (64.7)20/25 (80.0)p=0.19
Prediabetes status = Yes+ in mITT population
26 week follow up29/57 (50.9)20/49 (40.8)p=0.33
52 week follow up29/57 (50.9)29/49 (59.2)p=0.44
Diabetes Status = Yes in observed++ population
26 week follow up7/14 (50.0)11/16 (68.8)p=0.008
52 week follow up8/14 (57.1)12/16 (75.0)p=0.31
Prediabetes Status = Yes in observed population
26 week follow up17/43 (39.5)11/34 (32.4)p=0.63
52 week follow up16/43 (37.2)15/34 (44.1)p=0.64
  • * Change scores are adjusted for baseline value, age, sex, site, race, and diabetes status using linear mixed models.

  • ** Diabetes status = Yes when HbA1c ≥ 6.5% or subject was on anti-diabetes medication

  • *** mITT population had a least 1 measured weight during follow up; if diabetes status was missing at a follow up time point, then the subject was categorized according to baseline status.

  • + Prediabetes status = Yes when HbA1c 5.7%-6.4% without anti-diabetes medication

  • ++ Observed population includes only those who had follow up at both week 26 and 52.