TABLE 1.
Characteristics of participants in the Framingham State Food Study1
| Characteristic | All enrolled 2 | Intention-to-treat 3 | Per protocol 4 |
|---|---|---|---|
| Categorical variables | |||
| Sex | |||
| Men | 49 (29.9) | 45 (30.4) | 33 (30.0) |
| Women | 115 (70.1) | 103 (69.6) | 77 (70.0) |
| Hispanic ethnicity | 25 (15.2) | 21 (14.2) | 18 (16.4) |
| Race | |||
| White | 128 (78.1) | 116 (78.4) | 84 (76.4) |
| Black | 17 (10.4) | 16 (10.8) | 11 (10.0) |
| Asian | 5 (3.0) | 5 (3.4) | 4 (3.6) |
| Unknown/Other | 14 (8.5) | 11 (7.4) | 11 (10.0) |
| Continuous variables | |||
| Weight at PRE, kg | 91.5 ± 18.2 | 91.2 ± 18.2 | 89.5 ± 16.6 |
| Height at PRE, cm | 167.7 ± 10.0 | 167.9 ± 10.0 | 167.3 ± 10.3 |
| BMI at PRE, kg/m2 | 32.4 ± 4.8 | 32.2 ± 4.8 | 31.8 ± 4.2 |
| Age at START, y | 38.0 ± 14.4 | 38.6 ± 14.4 | 39.8 ± 14.0 |
| Weight loss at START, % of PRE body weight | 10.5 ± 1.7 | 10.5 ± 1.6 | 10.5 ± 1.5 |
| Total energy expenditure at START, kcal/d | 2661 ± 547 | 2651 ± 557 | 2663 ± 559 |
For categorical variables, values are frequency (%). For continuous variables, values are mean ± SD. PRE, preweight loss; START, start of randomized trial (postweight loss, prerandomization).
N = 164. Two participants who were randomly assigned to a diet group had unusable START TEE data.
N = 148. Participants who completed the study were included in the ITT analyses. One participant (ITT only) had unusable START TEE data.
N = 110. Participants who completed the study and achieved weight-loss maintenance were included in the PP analyses.
ITT, intention-to-treat; PP, per protocol; TEE, total energy expenditure.