A total of 417 persons provided written informed consent for screening in the trial; of these, 291 underwent randomization (Figure 1FIGURE 1
Screening, Randomization, and Follow-up of Study Participants.
). The mean age was 45.3 years; 49.8% of the participants were men, and 38.1% were black (Table 1TABLE 1
Baseline Characteristics of the Study Participants.
). More than half the participants lived in supported housing, and almost 80% were unable to work. A total of 58.1% of the participants had schizophrenia or a schizoaffective disorder, 22.0% had bipolar disorder, and 12.0% had major depression. The mean number of psychotropic medications was 3.1. On average, there were 29 participants per study site (range, 18 to 45). Follow-up weights were obtained from 279 participants, out of 280 for whom data were not censored at 18 months. At follow-up visits, 93.3% of the participants had their weight measured within the data-collection windows