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RECRUITING
NCT06814509
NA

Delivering HOPE (Helping Women Optimize Prenatal Equity)

Sponsor: University of Arkansas

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

16 Years - 44 Years

Study Type

INTERVENTIONAL

Enrollment

1440

Start Date

2025-06-24

Completion Date

2029-12-31

Last Updated

2025-10-01

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Enhanced Standard of Care (ESoC)

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

BEHAVIORAL

Delivering 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