NCT06711627

Food Provision in Prenatal Care

Arkansas Community Engagement Alliance: Delivering Arkansas Perinatal Outcomes for Minority and Rural Women Through Innovative System Improvement to Create Equity

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (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 during pregnancy reduce the proportion of women who experience excessive gestational weight gain compared with standard of care (SoC)?" To answer this question, the investigators will conduct a randomized controlled trial with 400 pregnant women. Participants will be randomized 1:1 to either the Food Provision arm or the SoC arm, with approximately 200 participants per arm. Participants randomized to the SoC arm will receive the standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women, as well as $500 after delivery to be used specifically for baby items.Those randomized to the Food Provision arm will be provided the same nutritional and gestational weight gain counseling, as well as a total of $1000 during pregnancy to be used specifically for the purchase of healthy foods recommended in the nutritional counseling. Data for the primary outcome will be collected from birth records and from surveys conducted at baseline (pre-intervention), midpoint (between 24-36 weeks gestation), and post-intervention (\~8 weeks post-partum).

Conditions

• Pregnancy Complications
• Excessive Gestational Weight Gain

Interventions

Type	Name	Description
BEHAVIORAL	Standard of Care (SoC)	Standard recommended nutrition and gestational weight gain counseling.
BEHAVIORAL	Food Provision	Standard recommended nutrition and gestational weight gain counseling plus food provision.

Timeline

• Start date: 2025-05-20
• Primary completion: 2028-03-31
• Completion: 2028-03-31
• First posted: 2024-12-02
• Last updated: 2025-07-22

Locations

1 site across 1 country: United States