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NCT06814509Recruiting

Delivering HOPE (Helping Women Optimize Prenatal Equity)

Source: ClinicalTrials.gov · Last updated 26 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
1440 (estimated)
First submitted
3 Feb 2025
Start date
24 Jun 2025
Primary completion date
30 Jun 2029
Lead sponsor
University of Arkansas
NCT number
NCT06814509

What you commit to

  • Study type: Interventional
  • Planned participants: 1440
  • From 24 Jun 2025 to the primary completion date, 30 Jun 2029
  • 8 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

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

Age in the registry: 16 years to 44 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
1st Choice Healthcare
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CorningUnited StatesRecruiting
River Valley Primary Care Services
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LavacaUnited StatesRecruiting
Olly Neal Community Health Center
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MariannaUnited StatesRecruiting
Boston Mountain Rural Health Center
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MarshallUnited StatesRecruiting
Mainline Health Systems
Coordinator of this site? Confirm its status
MonticelloUnited StatesRecruiting
Jefferson Comprehensive Care System
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Pine BluffUnited StatesWithdrawn
Community Clinic
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SpringdaleUnited StatesRecruiting
East Arkansas Family Health Center
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West MemphisUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.