About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Aged 16-44 years
≤18 weeks pregnant
Speak English, Spanish, or Marshallese
Valid email address
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Enhanced Standard of Care (ESoC)
BehavioralStandard recommended nutrition and gestational weight gain counseling; WIC and SNAP enrollment assistance; emergency food referrals
Delivering HOPE
BehavioralESoC plus healthy food provision
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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University of Arkansas
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator