Actively Recruiting

Phase Not Applicable
Age: 16Years - 44Years
FEMALE
Healthy Volunteers
NCT06814509

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

Age: 16Years - 44Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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Delivering HOPE (Helping Women Optimize Prenatal Equity) | DecenTrialz