Delivering HOPE (Helping women optimize prenatal equity): Design and methods of a multi-site randomized controlled trial evaluating healthy food provision to reduce excessive gestational weight gain

Top Things to Know

The strongest cardiovascular evidence supports plant-forward dietary patterns such as Mediterranean and DASH diets that emphasize minimally processed foods rather than targeting specific macronutrient ratios.

The investigators expect that directly improving access to healthy foods may be more effective than counseling alone because it changes the food environment.

The study could provide important evidence for payers, health systems, and policymakers considering FIM benefits within prenatal care.

Summary of Conclusion/Findings

Delivering HOPE (Helping women Optimize Prenatal is a pragmatic, multi-site randomized controlled trial that will evaluate whether providing healthy food during pregnancy can reduce excessive gestational weight gain (EGWG) among pregnant women receiving care in seven Federally Qualified Health Centers in Arkansas. The trial plans to enroll 1,440 pregnant participants ages 16–44 and randomize them to either enhanced standard of care alone or enhanced standard of care plus a restricted-use grocery card for healthy foods valued at $1,000 to $3,000 depending on household size. Both groups will receive standardized nutrition and gestational weight gain counseling, food insecurity screening, and referrals to nutrition assistance programs, while the intervention group will also receive 20 weeks of healthy food support. The primary outcome will be excessive gestational weight gain, with secondary outcomes including dietary intake, gestational diabetes, hypertensive disorders of pregnancy, and delivery complications. The investigators hypothesize that improving access to healthy foods will reduce excessive gestational weight gain and potentially improve maternal and delivery outcomes by directly addressing food insecurity and other nutrition-related barriers. The study also includes a hybrid effectiveness-implementation evaluation to identify barriers and facilitators that could inform future clinical adoption and scale-up of Food Is Medicine programs in prenatal care settings.