RecruitingNot ApplicableNCT06711627

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


Sponsor

University of Arkansas

Enrollment

400 participants

Start Date

May 20, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Sex: FEMALEMin Age: 16 YearsMax Age: 44 Years

Inclusion Criteria5

  • Aged 16-44 years
  • <= 22 weeks Pregnant
  • Speak English, Spanish, or Marshallese
  • Valid email address
  • Resides in and plans to give birth in the state of Arkansas

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Interventions

BEHAVIORALStandard of Care (SoC)

Standard recommended nutrition and gestational weight gain counseling.

BEHAVIORALFood Provision

Standard recommended nutrition and gestational weight gain counseling plus food provision.


Locations(1)

UAMS Institute for Community Health Innovation

Springdale, Arkansas, United States

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NCT06711627


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