NCT06814509

Delivering HOPE (Helping Women Optimize Prenatal Equity)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,440 (estimated)
• Sponsor: University of Arkansas · Academic / Other
• Sex: Female
• Age: 16 Years – 44 Years
• Healthy volunteers: Accepted

Summary

The overarching research question is: "Does the provision of healthy food (Delivering HOPE) during pregnancy reduce the proportion of women who experience excessive gestational weight gain compared with enhanced standard of care (ESoC)?" To answer this question, the investigators will conduct a large multi-site randomized controlled trial with 1,440 women. Women will be randomized to either the Delivering HOPE arm or the ESoC arm, with approximately 720 participants per arm. Participants randomized to the ESoC arm will receive the standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women, WIC and SNAP enrollment assistance, referrals to safety net food organizations.Those randomized to the Delivering HOPE arm will be provided the same nutritional and gestational weight gain counseling, WIC and SNAP assistance, and food referrals, as well as a total of $1000/$2000/$3000 (depending on household size) during pregnancy to be used specifically for the purchase of healthy foods recommended in the nutritional counseling. Data for the primary outcome (pre-pregnancy weight and weight at delivery) will be collected from birth records.

Conditions

• Gestational Weight Gain
• Diet, Healthy
• Gestational Hypertension
• Gestational Diabetes
• Pregnancy Complications

Interventions

Type	Name	Description
BEHAVIORAL	Enhanced Standard of Care (ESoC)	Standard recommended nutrition and gestational weight gain counseling; WIC and SNAP enrollment assistance; emergency food referrals
BEHAVIORAL	Delivering HOPE	ESoC plus healthy food provision

Timeline

• Start date: 2025-06-24
• Primary completion: 2029-06-30
• Completion: 2029-12-31
• First posted: 2025-02-07
• Last updated: 2025-10-01

Locations

8 sites across 1 country: United States