NCT06814509 Delivering HOPE (Helping Women Optimize Prenatal Equity)
| NCT ID | NCT06814509 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Arkansas |
| Condition | Gestational Weight Gain |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,440 participants |
| Start Date | 2025-06-24 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,440 participants in total. It began in 2025-06-24 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Inclusion Criteria: * Aged 16-44 years * ≤18 weeks pregnant * Speak English, Spanish, or Marshallese * Valid email address
Contact & Investigator
Pearl McElfish, PhD
PRINCIPAL INVESTIGATOR
University of Arkansas
Frequently Asked Questions
Who can join the NCT06814509 clinical trial?
This trial is open to female participants only, aged 16 Years or older, up to 44 Years, studying Gestational Weight Gain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06814509 currently recruiting?
Yes, NCT06814509 is actively recruiting participants. Contact the research team at mbrowland@uams.edu for enrollment information.
Where is the NCT06814509 trial being conducted?
This trial is being conducted at Corning, United States, Lavaca, United States, Marianna, United States, Marshall, United States and 4 additional locations.
Who is sponsoring the NCT06814509 clinical trial?
NCT06814509 is sponsored by University of Arkansas. The principal investigator is Pearl McElfish, PhD at University of Arkansas. The trial plans to enroll 1,440 participants.