The ENCOURAGE healthy families study: A comparative effectiveness trial to reduce risk for type 2 diabetes in mothers and children

Introduction Trials in adults have demonstrated that interventions targeting lifestyle are effective in preventing or delaying type 2 diabetes (T2D). To address this need in youth, we developed ENCOURAGE Healthy Families (ENCOURAGE), based on the US Diabetes Prevention Program (DPP). Study Design Here, we present results of the ENCOURAGE randomized, comparative effectiveness trial in which we evaluated ENCOURAGE delivered to (1) mothers only, and (2) mothers with added content delivered to their children. Participants The study was performed in Indianapolis, IN, at an academic medical center and the YMCA; December 2012 to April 2016. Women with a history of gestational diabetes mellitus (GDM) or prediabetes with children aged 8 to 15 years enrolled (n = 128). Outcome Measures Outcomes were collected at baseline, postintervention (3 months), 6 and 12 months. The primary outcome was weight change at 3 months in adults; secondary outcomes included glycosylated hemoglobin (HbA1c), lipids, and blood pressure. Results In neither program did mothers' weight change. HbA1c decreased at 3 months in both groups (mothers only=−0.09%, P = .019; mothers and children=−0.11%, P = .003). Participating children had a reduction in body mass index (BMI) percentile at 3 (−1.77, P = .014), 6 (−3.0, P = .002), and 12 months (−2.91, P = .004). HbA1c decreased in children in both groups (mothers only = −0.12% at 3 months [P < .0001], −0.13% at 6 months [P < .001], and −0.07% at 12 months [P = .001]; mothers and children = −0.08% at 3 months (P < .0001), −0.07% at 6 months (P = .0004), and −0.04% at 12 months (P = .03). Conclusion ENCOURAGE was beneficial for reducing BMI percentile in participating children.