Table 4.
Safety alerts, non-serious adverse events, and serious adverse events by intervention condition (n=470).
From Signing Informed Consent through Baseline Assessment* | Following Baseline and Through 6 Month Assessment* | Following 6 Month and through 12 Month Assessment* | Following 12 Month and through 18 Month Assessment* | Following 18 Month and Through 24 Month Assessment* | |
---|---|---|---|---|---|
Resting Blood Pressure Alert** | |||||
SBWI group | 4 | 3 | 2 | 2 | 0 |
EBWI group | 5 | 3 | 3 | 4 | 3 |
Depression Alert*** (CES-D score of 13 or higher) alert | |||||
SBWI group | 11 | 8 | 4 | 3 | 4 |
EBWI group | 7 | 10 | 7 | 7 | 8 |
Rapid Weight Loss Alert**** | |||||
SBWI group | – | 22 | 2 | 0 | 1 |
EBWI group | – | 18 | 0 | 0 | 0 |
Non-Serious Adverse Events | |||||
SBWI group | 10 | 36 | 38 | 20 | 27 |
EBWI group | 5 | 47 | 34 | 32 | 34 |
Serious Adverse Events***** | |||||
SBWI group | 0 | 1 | 2 | 2 | 1 |
EBWI group | 0 | 1 | 3 | 5 | 2 |
Data presented as number of participants
Resting systolic blood pressure >140 mmHg or resting diastolic blood pressure >90 mmHg.
Score of >13 of the Center for Epidemiologic Studies Depression (CES-D) Questionnaire.
>6% weight loss during a 4 week period of the intervention, with the alert based on weight assessed during an intervention visit.
All serious adverse events were a result of an overnight hospitalization or surgery.