A Low-Intensity Nutrition Intervention Targeting Triglycerides in Gestational Diabetes: A Feasibility RCT
Abstract
Context: The conventional approach to diet therapy for gestational diabetes mellitus (GDM) is carbohydrate modification to mitigate glucose-mediated fetal macrosomia. Maternal triglyceride concentrations more strongly relate to infant adiposity than maternal glucose.
Objective: This work aimed 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 randomly assigned at approximately 30 weeks' gestation to a standard care group (ie, usual GDM management) or to an intervention group, at an allocation ratio of 1:1. The intervention group received standard care plus individual counseling on reducing intake of ultraprocessed 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 birth weight.
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 randomly assigned (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 ultraprocessed food…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 444 participants or records.
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