Abstract

Background: Mobile health interventions for reducing CVD risk have mixed effectiveness. One Drop’s (OD) digital solution integrates a mobile application, in-app coaching and connected devices (glucometer, blood pressure cuff, scale) to support management of pre-diabetes, diabetes and hypertension. Secondary analyses of the Fit-One pragmatic RCT evaluated effects of OD on lifestyle, clinical and psychological outcomes for people with CVD risks of hypertension and type 2 diabetes (T2D). Methods: Fit-One enrolled adults with diabetes (HbA1c &gt 7%) who had never used OD. Subjects were randomized to get OD only, OD with fitness tracker or a waitlist control group. Present analyses compared just OD only to control subjects with T2D and hypertension. At baseline and 3-months, subjects completed validated measures of general self-rated health (GSRH), eating behavior problems (PDQ), vigorous, moderate and walking activity (mins in past week), life satisfaction, depression (PHQ-2) and HbA1c tests. MI corrected for missingness. Intent-to-treat (ITT) and per protocol (PP) analyses used ANCOVA and logistic models controlling for baseline outcomes. Results: Participants (N=115) tended to be female, white, non-hispanic and had health insurance. Treatment (N = 58) and control (N = 57) did not differ in baseline demographics or outcomes. In ITT models, main effects for general health, moderate activity, life satisfaction and depression and significant interactions for eating behavior problems, walking and A1c indicated benefit to the OD group (p &lt .05). Vigorous activity was not significant. PP models replicated findings yet moderate activity was not significant (p = .07), likely due to lower power. Within the OD group, moderate activity increased (p = .01). Conclusions: Over 3 months, OD users realized 15% higher health ratings (from 2.2); 10% fewer eating behavior problems (from 4.1); 105% more walking, 132% more moderate activity and 55% more vigorous activity (from 77, 67, 35 mins/wk); .72% absolute reduction in A1c and 4.7 times lower risk of depression vs. control (all PP). RCT results support the effectiveness of One Drop’s digital solution in improving lifestyle risks, glycemic control and psychological well-being in people at risk for CVD.

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