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NCT06814509NARecruitingAccepts Healthy Volunteers

Delivering HOPE (Helping Women Optimize Prenatal Equity)

University of Arkansas

Start Date

6/24/2025

Completion Date

12/31/2029

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 Criteria

Age Range: 16 years to 44 years

Inclusion Criteria: * Aged 16-44 years * ≤18 weeks pregnant * Speak English, Spanish, or Marshallese * Valid email address

Interventions

BEHAVIORAL

Enhanced Standard of Care (ESoC)

BEHAVIORAL

Delivering HOPE

Interested in This Trial?

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Conditions

Gestational Weight GainDiet, HealthyGestational HypertensionGestational DiabetesPregnancy Complications

Locations

1st Choice Healthcare

Corning, Arkansas 72422

United States

River Valley Primary Care Services

Lavaca, Arkansas 72941

United States

Olly Neal Community Health Center

Marianna, Arkansas 72360

United States

Boston Mountain Rural Health Center

Marshall, Arkansas 72650

United States

Mainline Health Systems

Monticello, Arkansas 71655

United States

Jefferson Comprehensive Care System

Pine Bluff, Arkansas 71601

United States

Community Clinic

Springdale, Arkansas 72764

United States

East Arkansas Family Health Center

West Memphis, Arkansas 72301

United States