Delivering HOPE (Helping Women Optimize Prenatal Equity)

University of Arkansas

Status: Enrolling

Conditions: Gestational Diabetes; Pregnancy Complications; Gestational Hypertension; Gestational Weight Gain; Diet, Healthy

Treatments: Behavioral: Enhanced Standard of Care (ESoC); Behavioral: Delivering HOPE

Study type: Interventional

Funder types: Other

Identifiers

NCT06814509

298238

Details and patient eligibility

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.

Enrollment: 1,440 estimated patients

Sex: Female

Ages: 16 to 44 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Aged 16-44 years
• ≤18 weeks pregnant
• Speak English, Spanish, or Marshallese
• Valid email address

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,440 participants in 2 patient groups

Enhanced Standard of Care (ESoC)

Active Comparator group

Description:

The ESoC arm includes implementing a standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women; implementing a standard protocol for helping participants sign up for WIC and SNAP; and implementing a standard protocol for providing referrals to safety net food organizations.

Treatment:

Behavioral: Enhanced Standard of Care (ESoC)

Delivering HOPE

Experimental group

Description:

The Delivering HOPE arm includes providing the same nutritional and gestational weight gain counseling, WIC and SNAP assistance, and referral assistance as ESoC. In addition, participants in the Delivering HOPE arm will be provided with funds during their pregnancy to be used specifically for the purchase of healthy foods. The amount will vary based on household size as follows: $1,000 (one to two household members), $2,000 (three to four household members), or $3,000 (five plus household members).

Treatment:

Behavioral: Delivering HOPE