Preventing Gestational Diabetes with a Healthy Gut Diet: Protocol for a Pilot, Feasibility Randomized Controlled Trial

Around 14% of pregnancies globally are affected by gestational diabetes mellitus (GDM), making it one of the most common disorders experienced by women in pregnancy. While dietary, physical activity and supplement interventions have been implemented to prevent GDM, with varying levels of success, altering the gut microbiota through diet is a promising strategy for prevention. Several studies have demonstrated that women with GDM likely have a different gut microbiota to pregnant women without GDM, demonstrating that the gut microbiota may play a part in glycemic control and the development of GDM. To date, there have been no randomized controlled trials using diet to alter the gut microbiota in pregnancy with the aim of preventing GDM. Here, we present the study protocol for a single-blind randomized controlled trial which aims to determine the effectiveness of the Healthy Gut Diet on reducing the diagnosis of GDM in pregnant women with one or more risk factors. Consenting women will be randomized into either the Healthy Gut Diet intervention group or the usual care (control) group after 11 weeks gestation. The women in the intervention group will receive three telehealth counseling appointments with an Accredited Practicing Dietitian with the aim of educating and empowering these women to build a healthy gut microbiota through their diet. The intervention was co-designed with women who have lived experience of GDM and incorporates published behavior change techniques. The control group will receive the usual care and will also be shown a brief (3 min) video on general healthy eating in pregnancy. The primary outcome is the diagnosis of GDM at any stage of the pregnancy. Secondary outcomes include changes to gut microbiota composition and diversity; gestational weight gain; maternal and infant outcomes; management of GDM (where relevant); dietary quality and intake; physical activity; and depression scoring. We aim to recruit 120 women over 16 months. Recruitment commenced in January 2023. The trial has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN12622001285741).