Diet, Healthy, Gestational Diabetes, Gestational Hypertension, Gestational Weight Gain, Pregnancy Complications
Conditions
Brief 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.
Interventions
BEHAVIORALEnhanced Standard of Care (ESoC)
Standard recommended nutrition and gestational weight gain counseling; WIC and SNAP enrollment assistance; emergency food referrals
BEHAVIORALDelivering HOPE
ESoC plus healthy food provision
Sponsors
University of Arkansas
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 44 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 16-44 years * ≤18 weeks pregnant * Speak English, Spanish, or Marshallese * Valid email address
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Excessive gestational weight gain (EGWG) | Baseline to Post-partum (approx. 40 weeks) | 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. |
Countries
United States
Contacts
CONTACTBrett Rowland
CONTACTSarah Pollock
PRINCIPAL_INVESTIGATORPearl McElfish, PhD
University of Arkansas
PRINCIPAL_INVESTIGATORLanita White, PharmD
Community Health Centers of Arkansas
Outcome results
None listed