RecruitingNot ApplicableNCT06814509

Delivering HOPE (Helping Women Optimize Prenatal Equity)


Sponsor

University of Arkansas

Enrollment

1,440 participants

Start Date

Jun 24, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 16 YearsMax Age: 44 Years

Inclusion Criteria4

  • Aged 16-44 years
  • ≤18 weeks pregnant
  • Speak English, Spanish, or Marshallese
  • Valid email address

Interventions

BEHAVIORALEnhanced Standard of Care (ESoC)

Standard recommended nutrition and gestational weight gain counseling; WIC and SNAP enrollment assistance; emergency food referrals

BEHAVIORALDelivering HOPE

ESoC plus healthy food provision


Locations(8)

1st Choice Healthcare

Corning, Arkansas, United States

River Valley Primary Care Services

Lavaca, Arkansas, United States

Olly Neal Community Health Center

Marianna, Arkansas, United States

Boston Mountain Rural Health Center

Marshall, Arkansas, United States

Mainline Health Systems

Monticello, Arkansas, United States

Jefferson Comprehensive Care System

Pine Bluff, Arkansas, United States

Community Clinic

Springdale, Arkansas, United States

East Arkansas Family Health Center

West Memphis, Arkansas, United States

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NCT06814509


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