Healthy eating and active living after gestational diabetes mellitus (HEALD-GDM): Rationale, design, and proposed evaluation of a randomized controlled trial

Background Gestational diabetes mellitus (GDM) is a common complication in pregnancy and a significant risk factor for type 2 diabetes (T2D). Most women who have had GDM are not engaging in health behaviours known to reduce their risk for developing future T2D. The objective of this study is to evaluate the effectiveness of a lifestyle modification program targeting healthy eating and active living behaviours after a GDM pregnancy. Method This trial will randomize 100 women to either a lifestyle modification program or a control condition. Those allocated to the Healthy Eating and Active Living for Diabetes and Gestational Diabetes Mellitus (HEALD-GDM), program will receive a previously developed and tested 24-week program led by an Exercise Specialist at a local recreational facility. The original HEALD program will be tailored for women with GDM through the provision of complementary childcare at HEALD-GDM sessions and theory-guided peer-led telephone support. Our primary outcome is the 6-month change in objectively derived average daily moderate and vigorous physical activity. Discussion Programs to increase physical activity in women with GDM should carefully consider and find ways to address known barriers specific to this population. We believe that our modified program may be successfully translated to women who have had GDM.