A randomized trial to test the effectiveness of two technology-enhanced diabetes prevention programs in primary care: The DiaBEAT-it Study. (Preprint)

Abstract

Lifestyle interventions targeting physical activity and improved eating habits have demonstrated that modest weight loss can prevent or delay the onset of type-2 diabetes. However, translation of these interventions into typical clinical programs remains a challenge.

To evaluate the effectiveness of two technology-enhanced interventions for diabetes prevention among adults at risk for developing diabetes in a primary care setting.

The DiaBEAT-it study employed a hybrid 2-group preference (Choice) and 3-group randomized controlled (RCT) design. This paper presents the weight related primary outcomes of the RCT arm. Patients from Southwest Virginia were identified through the Carilion Clinic electronic health records. Eligible participants (18 and older, BMI≥25, no Type 2 Diabetes) were randomized to either Choice (n=264) or RCT (n=334). RCT individuals were further randomized to one of three groups: (1) a 2-hour small group class to help patients develop a personal action plan to prevent diabetes (SC, n=117); (2) a 2-hour small group class plus automated telephone calls using an interactive voice response system (IVR) to help participants initiate weight loss through a healthful diet and regular physical activity (Class/IVR, n=110); or (3) a DVD with same content as the class plus the same IVR calls over a period of 12 months (DVD/IVR, n=107). Height was assessed with a calibrated stadiometer, weight with a calibrated Health-O-Meter stand-on scale.

Intention to treat analyses, controlling for gender, race, age and baseline BMI, showed that DVD/IVR and Class/IVR led to reductions in BMI at 6 (DVD/IVR -0.94, p<.001; Class/IVR -0.70, p<.01), 12 (DVD/IVR -0.88, p<.001; Class/IVR-0.82, p<.001) and 18 (DVD/IVR -0.78, p<.001; Class/IVR -0.58, p<.01) months. All three groups showed a significant number of participants losing at least 5% of their body weight at 12 months (DVD/IVR 26.87%; Class/IVR 21.62%; SC 16.85%). When comparing groups, DVD/IVR were significantly more likely to decrease BMI at 6 months (p<.05) and maintain the reduction at 18 months (p<.05) when compared to SC. There were no differences between the other groups.

These findings suggest that both IVR delivered interventions were effective in reducing and maintaining weight reduction in a group of primary care patients at risk for developing type 2 diabetes. The DiaBEAT-it interventions show promise in responding to the need for scalable, effective methods to manage obesity and prevent diabetes in primary care settings that do not over burden primary care clinics and providers.

clinicaltrials.gov NCT02162901, https://clinicaltrials.gov/ct2/show/NCT02162901

RR2-doi: 10.1016/j.cct.2014.06.010