Recruiting

Delivering HOPE

Sponsor:

University of Arkansas

Code:

NCT06814509

Conditions

Gestational Weight Gain

Diet, Healthy

Gestational Hypertension

Gestational Diabetes

Pregnancy Complications

Eligibility Criteria

Sex: Female

Age: 16 - 44

Healthy Volunteers: Accepted

Interventions

Enhanced Standard of Care (ESoC)

Delivering HOPE

Study Details

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.

Conditions

Gestational Weight Gain

Diet, Healthy

Gestational Hypertension

Gestational Diabetes

Pregnancy Complications

Study ID

NCT06814509

Start date

Jun 24, 2025

Status verified date

Jun, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 16 - 44

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Study Design

Enrollment

1440 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Enhanced Standard of Care (ESoC)

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.

experimental: Delivering HOPE

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).

Interventions

Enhanced Standard of Care (ESoC)

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

Delivering HOPE

ESoC plus healthy food provision

Primary outcome measure

  • Excessive gestational weight gain (EGWG) [ Time Frame: Baseline to Post-partum (approx. 40 weeks) ]

Central Contacts and Locations

Central contacts

Locations

1st Choice Healthcare

Recruiting

Corning, Arkansas, United States, 72422

Contacts

River Valley Primary Care Services

Recruiting

Lavaca, Arkansas, United States, 72941

Contacts

Olly Neal Community Health Center

Recruiting

Marianna, Arkansas, United States, 72360

Contacts

Boston Mountain Rural Health Center

Recruiting

Marshall, Arkansas, United States, 72650

Contacts

Mainline Health Systems

Recruiting

Monticello, Arkansas, United States, 71655

Contacts

Community Clinic

Recruiting

Springdale, Arkansas, United States, 72764

Contacts

East Arkansas Family Health Center

Recruiting

West Memphis, Arkansas, United States, 72301

Contacts

More Information

Sponsor

University of Arkansas

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arkansas on 2026-06-26.