Adults (n=339) at risk of diabetes, 68.1% with Metabolic Syndrome (MetSyn), were randomized to immediate intervention or to 6-month delayed control. Other than quarterly clinic visits for blood and weight measurement, there was no contact with study staff. The intervention, Alive-PD, was algorithm-driven, low-cost, and had no human coaching. Published 6-month results showed significant (p<0.001) treatment vs. control effects on HbA1c, glucose (FG), and weight.

Baseline means (SD) were: age 55 (8.9)y, BMI 31.2 (4.4), FG 109.9 (8.4) mg/dL, HbA1c 5.6 (0.3)%. Most were male (68.7%), college-educated (82%), and white (68%).

We calculated change from baseline to 12 months, and MetSyn severity Z-score (MetSynZ), a continuous variable associated with long-term risk for CVD, T2DM and MetSyn. We present data for those who provided 12-month biometric data (n=240), and also an intention-to-treat analysis for all 339 using Last Observation Carried Forward (LOCF).

In the 240 with 12-month data, pre-post improvements at 1 year were significant at p<0.001 for HbA1c, weight, waist, HDL, TG/HDL ratio and MetSynZ. The pre-post effect sizes ((12-month - baseline)/SD) were -0.50 for waist (half a SD), -0.43 for HbA1c and -0.36 for MetSynZ. These represent medium to low-medium effects. Changes, effect sizes and significance were similar in the LOCF n=339 analysis. Effect sizes of other analytes were significant but small. Only change in FG failed to maintain significance at 1 year.

Prevalence of metabolic syndrome was 68% at baseline, similar to that of the DPP sample (70%). It fell to 42% at 1 year, similar to that of DPP (45%). The MetSyn severity Z-score declined from 0.60 to 0.32, p<0.001. Insulin resistance by TG/HDL fell from 41% to 27% at 12 months.

These data indicate that at least for well-educated participants receiving quarterly clinic visits, this automated online coach-free program can help users achieve and maintain significant and non-trivial one-year reductions in risk of MetSyn and T2DM at relatively low cost.

Disclosure

G. Block: Other Relationship; Self; Turnaround Health (NutritionQuest). T. Block: Other Relationship; Self; Turnaround Health. C.H. Block: None.

Funding

National Institutes of Health

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