A low-intensity nutrition intervention targeting triglycerides in gestational diabetes: a feasibility RCT.

Aim: To assess the feasibility of a low-intensity dietary intervention designed to attenuate the rise in triglycerides compared to standard GDM management.

Methods: Women with GDM were randomised at ∼30 weeks' gestation to a standard care group (i.e. usual GDM management) or to an intervention group, at an allocation ratio of 1:1. The intervention group received standard care plus individual counselling on reducing intake of ultra-processed foods, increasing fruits, vegetables, fish and nuts, and changes to healthier fats. The primary outcome is study feasibility; secondary and exploratory outcomes include maternal dietary intakes, plasma triglyceride and glucose levels, and birthweight.

Results: Over 10 months of active recruitment, 444 women were invited to participate. Of these, 59 were eligible (13.2%), 38 (8.6%) consented and were randomised (n=19 intervention, n=19 standard care) and 34 women completed the study. The recruitment rate was 1 per week, the retention rate was 89.5% and the feasibility of eligibility criteria was 70.4%. Nearly all women in the intervention group who responded to the questionnaire (n=15/16) reduced their ultra-processed food intake and 11 women increased their intake of nuts. There was no end of study differences in non-fasting plasma triglycerides (mean (95%CI) in intervention, 2.84 (2.22, 3.46) mmol/L vs standard care, 3.40 (2.78, 4.02) mmol/L). Mean birthweight was higher in the standard care group vs intervention group (mean difference (95% CI): 479.5 (110.7, 848.3) g).

Conclusions: There was a modest recruitment rate and a high retention rate, indicating a diet aimed at attenuating triglyceride is feasible and highly acceptable in women with GDM. The positive improvements observed in maternal diet and desirable birthweight, warrants further investigation in a larger, definitive, randomised controlled trial.