Results of the Optimizing Outcomes in Women with Gestational Diabetes Mellitus and Their Infants, a Cluster Randomized, Controlled Pilot Study: Lessons Learned.

Abstract

The purpose of this pilot study was as follows: Aim I was to determine the feasibility of the intervention, including its acceptability, and tofurther refine intervention materials and study procedures including recruitment, enrollment, intervention, retention, and data collection. Aim 2 was to test the initial effects of the intervention on the primary outcome of fasting blood glucose and secondary outcomes including metabolic, clinical, adiposity, health behavior, and self-efficacy outcomes in women. Aim 3 examined infant feeding. Infant weight and adiposity growth are discussed in this manuscript. The intervention group received the Phase I intervention, which included 14 classes, each lasting 60 minutes, with the first class delivered during pregnancy on the benefits of breastfeeding for maternal metabolic control andfor infant health. The classes resumed 6 weeks postpartum and were delivered weekly. The Phase II intervention included 3 monthly classes, each lasting 60 minutes, during which the interventionist facilitated a group discussion and assisted the women with problems related to breastfeeding, nutrition, or exercise. Results demonstrated that 100 women were enrolled in the study; however, secondary to the majority of women returning to work part-time or full-time, the retention for the intervention and data collection was poor. In addition, statistical significancefor the primary outcomes was not achieved. However, women made some changes in adiposity and health behaviors, and infants made changes in adiposity growth. Both lessons learned and future research are discussed.