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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: Recruiting NA study of Diet, Healthy and Gestational Diabetes, sponsored by University of Arkansas.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Pre-pregnancy weight and weight immediately prior to birth will be used to calculate total weight gain, adjusting for pre-pregnancy body mass index and weeks of gestation. Individuals whose total weight gain exceeds established guidelines will be determined to have EGWG. We will examine the difference in the proportion of women who experience EGWG.

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

FieldValue
Enrollment Target 1,440 participants
Start Date 2025-06-24
Est. Completion 2029-12-31
Phase NA
University of Arkansas

318 total trials

What NCT06814509 shows while recruiting

NCT06814509 is an interventional study that assigns participants to a tested intervention. Its 1,440 participants enrollment target places it among the larger protocols in the corpus, above the 477-participant average among 48 other Diet, Healthy trials with a reported enrollment target (202% higher).

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 lists 8 locations in 1 state (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.

Similar trials for Diet, Healthy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06814509's enrollment target sits among peer trials

1,440 5th of 48 higher than 44 of 48 other Diet, Healthy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Diet, Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06814509, the US trial registry maintained by the National Library of Medicine. NCT06814509 (large enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.