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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,440
Standard recommended nutrition and gestational weight gain counseling; WIC and SNAP enrollment assistance; emergency food referrals
ESoC plus healthy food provision
1st Choice Healthcare
Corning, Arkansas, United States
RECRUITINGRiver Valley Primary Care Services
Lavaca, Arkansas, United States
RECRUITINGOlly Neal Community Health Center
Marianna, Arkansas, United States
RECRUITINGBoston Mountain Rural Health Center
Marshall, Arkansas, United States
RECRUITINGMainline Health Systems
Monticello, Arkansas, United States
RECRUITINGJefferson Comprehensive Care System
Pine Bluff, Arkansas, United States
WITHDRAWNCommunity Clinic
Springdale, Arkansas, United States
RECRUITINGEast Arkansas Family Health Center
West Memphis, Arkansas, United States
RECRUITINGExcessive 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.
Time frame: Baseline to Post-partum (approx. 40 weeks)
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