Delivering HOPE (Helping Women Optimize Prenatal Equity)

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

• Gestational Weight Gain
• Diet, Healthy
• Gestational Hypertension
• Gestational Diabetes
• Pregnancy Complications

Interventions

BEHAVIORAL

Enhanced Standard of Care (ESoC)

Standard recommended nutrition and gestational weight gain counseling; WIC and SNAP enrollment assistance; emergency food referrals

BEHAVIORAL

Delivering HOPE

ESoC plus healthy food provision

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• University of Arkansas

  lead OTHER

Principal Investigators

• Pearl McElfish, PhD · University of Arkansas

• Lanita White, PharmD · Community Health Centers of Arkansas

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

44 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-06-24

Primary Completion

2029-06-30

Completion

2029-12-31

Countries

• United States

Study Locations