This pilot feasibility randomized controlled trial enrolled pregnant individuals with gestational diabetes from maternal fetal medicine clinics in Hartford, Connecticut. The intervention combined medically-tailored meal delivery, personalized physical activity support, and multimodal education with digital tools, added to usual GDM care. The comparator was usual GDM care alone.
Of 30 individuals approached, 80% (n=24) were screened, and 75% (n=18/24) were eligible. Eight participants were randomized; 75% (n=6/8) completed at least one component of follow-up (100% Meals4Moms, 50% Usual Care). One Meals4Moms participant spent ≥80% of her total food budget (n=1/4, 25%). No participants completed ≥80% of prescribed exercise sessions (range: 0-50%).
All (n=4) Meals4Moms participants reported they would be very likely to participate again and recommend the program. Adverse events, serious adverse events, discontinuations, and tolerability were not reported.
Key limitations include a small sample size (n=8 randomized), high attrition (only 75% completed follow-up), and no clinical outcomes measured. The intervention was highly acceptable, but procedural refinements are needed before a full-scale efficacy trial. This pilot does not establish causation for clinical outcomes, and results have low certainty for generalizability.
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Background: Lifestyle interventions incorporating medically-tailored meal delivery may support rapid behavior change among pregnant individuals with gestational diabetes (GDM). Purpose: To examine the feasibility and acceptability of a multicomponent lifestyle intervention for pregnant individuals with GDM. Primary outcomes included recruitment, retention, intervention receipt, and acceptability. Methods: We conducted a pilot randomized feasibility trial among pregnant individuals with GDM recruited from maternal fetal medicine clinics in the Hartford, Connecticut area. Participants were randomized to usual GDM care or the Meals4Moms intervention plus usual care. The intervention included medically-tailored meal delivery, personalized physical activity support, and multimodal education with digital tools. Participants completed a survey and three 24-hour dietary recalls at baseline and post-intervention. Meals4Moms participants also completed a semi-structured interview at follow-up. Intervention receipt was tracked by study staff. Results: Of 30 individuals approached, we screened 80% (n=24), of whom 75% (n=18/24) were eligible; we randomized 8 participants. Seventy-five percent (n=6/8) completed at least one component of the follow-up assessment (100%, n=4/4 Meals4Moms, 50%, n=2/4 Usual Care). One participant spent [≥]80% of her total food budget (n=1/4, 25%), and no participants completed [≥]80% of prescribed exercise sessions (range: 0-50%). All (n=4) Meals4Moms participants reported they would be very likely to participate in the program if they had GDM again, and 100% (n=4) would be very likely to recommend the program to a friend with GDM. Conclusions: While the Meals4Moms intervention was highly acceptable to participants, procedural refinements are needed prior to conducting a full-scale efficacy trial.