Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Feasibility of lifestyle intervention |
Feasibility of the lifestyle intervention will be assessed by the satisfaction level of participants which will be obtained from questions on an investigator developed questionnaire. Higher satisfaction levels will suggest greater feasibility. |
22 weeks |
|
Primary |
Tolerability of educational nutritional sessions |
Individual attendance levels will be measured at weekly intervals during educational nutrition didactic sessions. Attendance will be calculated as the total number of attended groups divided by the total number of eligible groups to account for the late enrollment of individuals. |
22 weeks |
|
Primary |
Tolerability of group fitness classes |
Individual attendance levels will be measured at weekly intervals during group fitness classes. Attendance will be calculated as the total number of attended groups divided by the total number of eligible groups to account for the late enrollment of individuals. |
22 weeks |
|
Secondary |
Change in physical activity level |
Change in physical activity level will be measured through step counts which will be collected throughout the active intervention period via pedometers provided to study participants at the beginning of the trial period. Step counts will be logged weekly at group fitness classes. |
baseline, 22 weeks |
|
Secondary |
Change in weight |
Participants will be asked to weigh themselves and document their weight. Either before or after each session the participant will share their weight with a research assistant on a phone call without other participants present. |
baseline, 22 weeks |
|
Secondary |
Change in resting heart rate |
Participants will be taught how to obtain a resting heart rate and asked to document their resting heart rate. Either before or after each session the participant will share their resting heart rate with a research assistant on a phone call without other participants present. |
baseline, 22 weeks |
|
Secondary |
Change in Hemoglobin A1c level (HbA1c) |
Study staff will abstract the HbA1c levels from the patient's Boston Medical Center (BMC) electronic record. |
baseline, 22 weeks |
|
Secondary |
Change in psychological well being |
Change in psychological well-being will be assessed through the administration of the Personal Health Questionnaire-9 (PHQ-9).The PHQ-9 has been previously validated in the general population to assess for major depressive disorder and subclinical depressive symptoms. Scores can range from 1-27 and the higher the score the greater the depressive symptoms. |
baseline, 22 weeks |
|
Secondary |
Change in self esteem |
The change in scores from baseline to 22 weeks from the 12-item Short Form Health Survey (12-SFHS), State Self-Esteem Scale (SSES) will be used to assess self esteem change. The SSES scale has been validated in multiple populations as an assessment of an individual's sense of worthiness in three domains: (1) appearance, (2) performance, and (3) social Each item is scored on a 5-point scale (1 = not at all, 2 = a little bit, 3 = somewhat, 4 = very much, and 5 = extremely). Scores range form 20 to 100 and higher scores are associated with higher self esteem. |
baseline, 22 weeks |
|
Secondary |
Change in psychotic episodes |
Change in psychotic symptoms will be assessed through implementation of the Brief Psychiatric Rating Scale (BPRS). The BPRS is a validated instrument which measures several constructs important to the assessment of the severity of symptoms of psychosis such as degree of hallucinations, unusual thought content, self-neglect, and conceptual disorganization. Higher scores are associated with more psychotic episodes |
baseline, 22 weeks |
|
Secondary |
Motivation to exercise |
Change in motivation to exercise will be measured through administration of Behavioral Regulation Exercise Questionnaire-3 (BREQ-3). Higher scores are associated with greater motivation to exercise. |
22 weeks |
|
Secondary |
Change in nutritional knowledge |
Change in nutrition knowledge will be measured through comparison of baseline and post intervention multiple choice test written by a registered dietician. |
baseline, 22 weeks |
|