Discussion
inflammation, depressive, psychiatric, depressive symptoms, depression, dysglycemia, diabetes
INFLAMMATION, SECONDARY, INSULIN RESISTANCE, INSULIN SENSITIVITY, DIABETES
The findings for the primary outcomes are that (1) the EWS + MTM intervention decreased HbA1c relative to SS at post-treatment, (2) both treatment groups decreased depressive symptoms relative to SS at 15 months, and, (3) there was no change in insulin resistance. For other biological variables there were trends for the EWS + MTM group to show decreased inflammation at post-treatment and decreased stress hormones at post-treatment and at follow-up. Whereas they were not among our primary or secondary outcomes, we found that waist circumference, SBP and DBP decreased at post-treatment and follow-up for all groups. There were no significant changes in lipids.Our first main finding is that in this sample, the combination of lifestyle and MTM reduced HbA1c, but lifestyle alone did not. The combination arm achieved a glycemia lowering effect of small-to-medium size (d = 0.28). This is commensurate with a meta-analysis of 69 lifestyle interventions for diabetes prevention at 12 monthsIt is important to note that the EWS + MTM group did not achieve superior glycemia via exposure to metformin. MTM recommendations to healthcare providers included the initiation of metformin for n = 16 of participants assigned to EWS + MTM—but none of them actually took or initiated metformin or other glucose lowering drugs. Indeed, we had hoped that, upon receiving the recommendation from the pharmacist accompanied by a detailed laboratory report, providers would initiate metformin, but in no case did this occur. Therefore, any effects of MTM were due to changes in other medications or to participant medication taking behaviors. Elsewhere we have reported that 90% of this sample had at least one drug therapy problem at baseline, the most common of which were safety problems. Our MTM intervention resolved 84% of those drug therapy problemsIt is important to remember that all participants met study criteria for depression at baseline. MTM provides the opportunity to resolve problems with psychiatric medications such as anti-depressants and third-generation antipsychotics that are associated with dysglycemia. Antidepressants are associated with an elevated risk of diabetes, with pooled adjusted Hazard Ratios (HRs) from 1.10 to 1.26 (e.g.,Another main finding, that there was no change in insulin resistance, suggests that any beneficial effects of MTM on HbA1c were not mediated by increased insulin sensitivity. Whereas some medications may increase glycemia directly (e.g., steroids), others do so indirectly via their action on insulin sensitivity (e.g., second-generation antipsychotics). We speculate that the decrease in HbA1c in the EWS + MTM group without a concomitant decrease in insulin resistance suggests that any medication changes made by the pharmacist may have had direct benefits on glycemia.The third main finding is that both treatment groups lowered depressive symptoms relative to SS, even though EWS was not designed as a depression treatment. EWS included scheduling, goal setting and increased socialization which are components of behavioral activation, a well validated depression treatmentSurprisingly, all groups showed decreased blood pressure and waist circumference over time. Whereas the SS group did not receive either of our active interventions per se, they did receive on-demand social services from CHWs that could putatively affect health such as referrals for food assistance, healthcare providers, assistance processing insurance documents, and translation of written materials. This finding underscores the health benefits of addressing ‘upstream’ social determinants of health, especially in underserved populations. Alternatively, contamination may have contributed to the benefits observed in the SS group. We ensured that people from the same family and/or household were randomized to the same arm. Nonetheless, since this is a tight-knit community, participants who were randomized to treatment may have shared intervention information with their friends from different families/households who were assigned to the SS group.That waist circumference (but not BMI) decreased over time for all groups may reflect that glycemia of east Asians, relative to other groups, is more sensitive to Our high retention rate is also quite noteworthy. We attribute this primarily to high level of skill of the community health educators who were carefully chosen, thoroughly trained, and regularly supervised. Participant satisfaction with the interventions was high