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.

BACKGROUND/AIMS: EGWG is a prevalent and modifiable risk factor for maternal morbidity and mortality. Food insecurity and limited access to healthy foods are key social determinants contributing to EGWG. METHODS: Delivering HOPE is a pragmatic, multi-site randomized controlled trial designed to evaluate whether a food is medicine intervention providing healthy food resources during pregnancy reduces EGWG and associated complications compared with an ESoC. The trial will be conducted in 7 FQHCs. Eligible participants will be pregnant women aged 16-44 years. Participants (N = 1440) will be enrolled and randomized 1:1. Both study arms will receive standardized GWG and nutrition counseling, as well as referrals to food resources. In addition, participants in the Delivering HOPE intervention will receive a directed-spend grocery card that may only be used for purchasing healthy food items aligned with nutritional counseling. The primary outcome is EGWG. Secondary outcomes include dietary intake and pregnancy and delivery complications. A hybrid type 1 effectiveness-implementation will also be conducted and will include qualitative evaluation of implementation barriers and facilitators. This study is grounded in a stakeholder engaged approach and co-led by one academic and one community principal investigator, and an SAAB including women with lived experience, health care providers, payers, state agencies, community-based food organizations, and researchers. CONCLUSIONS: Delivering HOPE addresses a critical gap in evidence by rigorously evaluating a scalable food is medicine intervention during pregnancy in high-risk populations. Findings will inform clinical, payer, and policy decisions regarding food provision as a strategy to improve maternal health equity.