Food Provision in Prenatal Care (NCT06711627)
Arkansas Community Engagement Alliance: Delivering Arkansas Perinatal Outcomes for Minority and Rural Women Through Innovative System Improvement to Create Equity
๐ฉบ Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: UAMS Institute for Community Health Innovation โ Springdale, Arkansas
Age range: 16 Years to 44 Years
๐งช Interventions in This Study
- Standard of Care (SoC) (BEHAVIORAL)
- Food Provision (BEHAVIORAL)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- UAMS Institute for Community Health Innovation โ Springdale, Arkansas
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.