Delivering HOPE (Helping Women Optimize Prenatal Equity)
Recruiting · NCT06814509 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Arkansas
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- Aged 16-44 years
- ≤18 weeks pregnant
- Speak English, Spanish, or Marshallese
- Valid email address
Where it is running
8 locations listed across 1 US state.
- 1st Choice Healthcare - Corning, Arkansas, United States
- River Valley Primary Care Services - Lavaca, Arkansas, United States
- Olly Neal Community Health Center - Marianna, Arkansas, United States
- Boston Mountain Rural Health Center - Marshall, Arkansas, United States
- Mainline Health Systems - Monticello, Arkansas, United States
- Jefferson Comprehensive Care System - Pine Bluff, Arkansas, United States
- Community Clinic - Springdale, Arkansas, United States
- East Arkansas Family Health Center - West Memphis, Arkansas, United States