Delivering HOPE (Helping Women Optimize Prenatal Equity)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age16-44
SponsorUniversity of Arkansas

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 volunteers

Qualifiers

Aged 16-44 years

≤18 weeks pregnant

Speak English, Spanish, or Marshallese

Valid email address

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Enhanced Standard of Care (ESoC)

    Behavioral

    Standard recommended nutrition and gestational weight gain counseling; WIC and SNAP enrollment assistance; emergency food referrals

  • Delivering HOPE

    Behavioral

    ESoC plus healthy food provision

Treatment groups

1,440 Participants
are divided into 2 treatment groups
Group A: Enhanced Standard of Care (ESoC)Active comparator 1 intervention
Group B: Delivering HOPEExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Baseline to Post-partum (approx. 40 weeks)

Secondary outcomes

Other outcomes

Sponsors and contacts

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University of Arkansas

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator