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NCT06814509 · ClinicalTrials.gov registry record · NA
Delivering HOPE (Helping Women Optimize Prenatal Equity)
A NA study of Diet, Healthy and Gestational Diabetes, sponsored by University of Arkansas.
- Recruiting
- Registry status
- NA
- Development phase
- 1,440
- Enrollment target
- 8
- Study locations
NCT06814509 is a NA study of Diet, Healthy and Gestational Diabetes that is actively recruiting participants, run by University of Arkansas. The registered enrollment target is 1,440 participants, above the 477-participant average among 48 other Diet, Healthy trials with a reported enrollment target (202% higher). The trial reports 8 study locations across 1 state.
The verdict
NCT06814509, a NA study of Diet, Healthy and Gestational Diabetes, is actively recruiting participants, sponsored by University of Arkansas.
- RECRUITING
- Registry status
- NA
- Development phase
- 1,440 participants
- Enrollment target
- 8
- Study locations
Study 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.
Conditions Studied
Interventions
- BEHAVIORAL Enhanced Standard of Care (ESoC)
- BEHAVIORAL Delivering HOPE
Study Locations (8)
Arkansas
- 1st Choice Healthcare - Corning
- River Valley Primary Care Services - Lavaca
- Olly Neal Community Health Center - Marianna
- Boston Mountain Rural Health Center - Marshall
- Mainline Health Systems - Monticello
- Jefferson Comprehensive Care System - Pine Bluff
- Community Clinic - Springdale
- East Arkansas Family Health Center - West Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,440 participants |
| Start Date | 2025-06-24 |
| Est. Completion | 2029-12-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06814509
The ClinicalTrials.gov registry entry for NCT06814509 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 1,440 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 477-participant average among 48 other Diet, Healthy trials with a reported enrollment target (202% higher). The listed sponsor is University of Arkansas, which has 318 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Diet, Healthy appearing as the primary indexed condition, and to 2 interventions - of which Enhanced Standard of Care (ESoC) is the first listed.
NCT06814509 reports 8 study locations spanning 1 distinct geographic area - top geographies include Arkansas.
Frequently Asked Questions
What is clinical trial NCT06814509 about?
NCT06814509 is a clinical study titled "Delivering HOPE (Helping Women Optimize Prenatal Equity)". 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 larg...
What is the current status of trial NCT06814509?
This trial is currently recruiting. It is a NA study. The enrollment target is 1,440 participants. The study started on 2025-06-24. Estimated completion is 2029-12-31.
What conditions does trial NCT06814509 study?
This clinical trial studies the following conditions: Diet, Healthy, Gestational Diabetes, Pregnancy Complications, Gestational Hypertension, Gestational Weight Gain.
What interventions are being tested in trial NCT06814509?
The interventions under investigation include: Enhanced Standard of Care (ESoC) (BEHAVIORAL), Delivering HOPE (BEHAVIORAL).
Who is sponsoring clinical trial NCT06814509?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06814509 being conducted?
This trial has 8 study locations across Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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