Delivering HOPE (Helping Women Optimize Prenatal Equity)
1 other identifier
interventional
1,440
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2025
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2025
CompletedFirst Posted
Study publicly available on registry
February 7, 2025
CompletedStudy Start
First participant enrolled
June 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
October 1, 2025
September 1, 2025
4 years
February 3, 2025
September 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Excessive gestational weight gain (EGWG)
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.
Baseline to Post-partum (approx. 40 weeks)
Study Arms (2)
Enhanced Standard of Care (ESoC)
ACTIVE COMPARATORThe ESoC arm includes implementing a standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women; implementing a standard protocol for helping participants sign up for WIC and SNAP; and implementing a standard protocol for providing referrals to safety net food organizations.
Delivering HOPE
EXPERIMENTALThe Delivering HOPE arm includes providing the same nutritional and gestational weight gain counseling, WIC and SNAP assistance, and referral assistance as ESoC. In addition, participants in the Delivering HOPE arm will be provided with funds during their pregnancy to be used specifically for the purchase of healthy foods. The amount will vary based on household size as follows: $1,000 (one to two household members), $2,000 (three to four household members), or $3,000 (five plus household members).
Interventions
Standard recommended nutrition and gestational weight gain counseling; WIC and SNAP enrollment assistance; emergency food referrals
Eligibility Criteria
You may qualify if:
- Aged 16-44 years
- ≤18 weeks pregnant
- Speak English, Spanish, or Marshallese
- Valid email address
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
1st Choice Healthcare
Corning, Arkansas, 72422, United States
River Valley Primary Care Services
Lavaca, Arkansas, 72941, United States
Olly Neal Community Health Center
Marianna, Arkansas, 72360, United States
Boston Mountain Rural Health Center
Marshall, Arkansas, 72650, United States
Mainline Health Systems
Monticello, Arkansas, 71655, United States
Jefferson Comprehensive Care System
Pine Bluff, Arkansas, 71601, United States
Community Clinic
Springdale, Arkansas, 72764, United States
East Arkansas Family Health Center
West Memphis, Arkansas, 72301, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pearl McElfish, PhD
University of Arkansas
- PRINCIPAL INVESTIGATOR
Lanita White, PharmD
Community Health Centers of Arkansas
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2025
First Posted
February 7, 2025
Study Start
June 24, 2025
Primary Completion (Estimated)
June 30, 2029
Study Completion (Estimated)
December 31, 2029
Last Updated
October 1, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share