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
- Diseases
- High blood pressure
- 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
Sites (8)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 1st Choice Healthcare Coordinator of this site? Confirm its status | Corning | United States | Recruiting |
| River Valley Primary Care Services Coordinator of this site? Confirm its status | Lavaca | United States | Recruiting |
| Olly Neal Community Health Center Coordinator of this site? Confirm its status | Marianna | United States | Recruiting |
| Boston Mountain Rural Health Center Coordinator of this site? Confirm its status | Marshall | United States | Recruiting |
| Mainline Health Systems Coordinator of this site? Confirm its status | Monticello | United States | Recruiting |
| Jefferson Comprehensive Care System Coordinator of this site? Confirm its status | Pine Bluff | United States | Withdrawn |
| Community Clinic Coordinator of this site? Confirm its status | Springdale | United States | Recruiting |
| East Arkansas Family Health Center Coordinator of this site? Confirm its status | West Memphis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.