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. Author manuscript; available in PMC: 2017 Sep 20.
Published in final edited form as: JAMA. 2016 Sep 20;316(11):1161–1171. doi: 10.1001/jama.2016.12858

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.

HHS Vulnerability Disclosure