Actively Recruiting
Delivering HOPE (Helping Women Optimize Prenatal Equity)
Led by University of Arkansas · Updated on 2025-10-01
1440
Participants Needed
8
Research Sites
235 weeks
Total Duration
On this page
Sponsors
U
University of Arkansas
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Delivering HOPE (Helping Women Optimize Prenatal Equity)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 16-44 years
- Pregnant at 18 weeks or less
- Speak English, Spanish, or Marshallese
- Have a valid email address
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 8 locations
1
1st Choice Healthcare
Corning, Arkansas, United States, 72422
Actively Recruiting
2
River Valley Primary Care Services
Lavaca, Arkansas, United States, 72941
Actively Recruiting
3
Olly Neal Community Health Center
Marianna, Arkansas, United States, 72360
Actively Recruiting
4
Boston Mountain Rural Health Center
Marshall, Arkansas, United States, 72650
Actively Recruiting
5
Mainline Health Systems
Monticello, Arkansas, United States, 71655
Actively Recruiting
6
Jefferson Comprehensive Care System
Pine Bluff, Arkansas, United States, 71601
Withdrawn
7
Community Clinic
Springdale, Arkansas, United States, 72764
Actively Recruiting
8
East Arkansas Family Health Center
West Memphis, Arkansas, United States, 72301
Actively Recruiting
Research Team
B
Brett Rowland
CONTACT
S
Sarah Pollock
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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