Mobile Delivery of the Diabetes Prevention Program in People with Pre-diabetes: A Randomized Controlled Trial.

BACKGROUND: To date, no randomized controlled trial has verified the efficacy of a fully mobile version of the diabetes prevention program (DPP).

OBJECTIVE: This study aimed to investigate the long-term weight loss and glycemic efficacy of a mobile-delivered DPP compared with a control group receiving usual medical care.

METHODS: Adults with prediabetes (N=202) were recruited from a clinic and randomized to either a mobile-delivered, coach-guided DPP or to a control group that received regular medical care including a paper-based DPP curriculum and no formal intervention. The intervention group learned how to use the Noom program, interact with their coach, and the importance of maintaining motivation. They had access to an interactive coach-to-participant interface and group messaging, daily challenges for behavior change, DPP-based education articles, food logging, and automated feedback. Primary outcomes included changes in weight and hemoglobin A1c (HbA1c) at 6 and 12 months. Exploratory secondary outcomes included program engagement as a predictor of changes in weight and HbA1c.

RESULTS: A total of 202 participants were recruited and randomized into the intervention (n=101) or control group (n=99). In intention-to-treat (ITT) analyses, change in the participants' weight and BMI was significantly different at 6 months in the intervention and control groups by -2.64 kg (SE 0.71; P<.001) and -0.99 kg/m2 (SE 0.29; P=.001), respectively, but HbA1c was not (0.004%; SE 0.05; P=.94). These differences persisted at 12 months. However, in analyses that did not involve ITT, program completers achieved a significant weight loss of 5.6% (SE 0.81; P<.001) at 6 months, maintaining 4.7% (SE 0.88; P<.001) of their loss at 12 months. The control group lost -0.15% at 6 months (SE 0.64; P=.85) and gained 0.33% (SE 0.70; P=.63) at 12 months. Those randomized to the intervention who did not start the program had no meaningful weight or HbA1c change, similar to the control group. At 1 year, the intervention group showed a 0.23% reduction in HbA1c; those who completed the intervention had a 0.28% reduction. Those assigned to the control group had a 0.16% reduction in HbA1c.

CONCLUSIONS: A novel mobile-delivered DPP achieved significant weight loss reductions for up to 1 year compared with usual care. This type of intervention reduces the risk of overt diabetes without the added barriers of in-person interventions.

CLINICALTRIAL: Clinicaltrials.gov NCT03865342; https://clinicaltrials.gov/ct2/show/NCT03865342.