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.

Ms. Sena is the CEO of My Local Chefs. Dr. Pescatello is founder and sole proprietor of P3-EX LLC which could potentially benefit from this research. Dr. Shields is a Principal Investigator of three AHRQ grants for developing a simulation course on maternal cardiac arrest; is an examiner for the ABOG specialty and subspecialty certifying exams; is a member of Varda5, LLC, a consulting company that owns the exclusive sublicense for Obstetric Life Support; is a co-owner for IP related to a maternal cardiac arrest simulator. No other authors have financial conflicts to disclose.

NCT06227247

This project was funded by a Clinical Research and Innovation Seed Program (CRISP) grant from the University of Connecticut and UConn Health (PI: Shields). Additional support was provided by a seed grant from the Institute for Collaboration on Health, Intervention, and Policy (InCHIP) at the University of Connecticut (PI: Shields).

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The UConn Health IRB gave ethical approval for this work.

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All data produced in the present study are available upon reasonable request to the authors.