Delivering HOPE (Helping Women Optimize Prenatal Equity)

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 16
Maximum Age: 44
Healthy Volunteers: t
View:

• Aged 16-44 years

• ≤18 weeks pregnant

• Speak English, Spanish, or Marshallese

• Valid email address

Locations
United States
Arkansas
1st Choice Healthcare
RECRUITING
Corning
River Valley Primary Care Services
RECRUITING
Lavaca
Olly Neal Community Health Center
RECRUITING
Marianna
Boston Mountain Rural Health Center
RECRUITING
Marshall
Mainline Health Systems
RECRUITING
Monticello
Jefferson Comprehensive Care System
WITHDRAWN
Pine Bluff
Community Clinic
RECRUITING
Springdale
East Arkansas Family Health Center
RECRUITING
West Memphis
Contact Information
Primary
Brett Rowland
mbrowland@uams.edu
479-713-8000
Backup
Sarah Pollock
SPollack@uams.edu
479-713-8000
Time Frame
Start Date: 2025-06-24
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 1440
Treatments
Active_comparator: Enhanced Standard of Care (ESoC)
The 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.
Experimental: Delivering HOPE
The 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).
Related Therapeutic Areas
Sponsors
Leads: University of Arkansas
Collaborators: Patient-Centered Outcomes Research Institute

This content was sourced from clinicaltrials.gov