Food Provision in Prenatal Care

NCT ID: NCT06711627

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-20
• Study Completion Date: 2028-03-31

Brief Summary

The overarching research question is: "Does the provision of healthy food during pregnancy reduce the proportion of women who experience excessive gestational weight gain compared with standard of care (SoC)?" To answer this question, the investigators will conduct a randomized controlled trial with 400 pregnant women. Participants will be randomized 1:1 to either the Food Provision arm or the SoC arm, with approximately 200 participants per arm. Participants randomized to the SoC arm will receive the standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women, as well as $500 after delivery to be used specifically for baby items.Those randomized to the Food Provision arm will be provided the same nutritional and gestational weight gain counseling, as well as a total of $1000 during pregnancy to be used specifically for the purchase of healthy foods recommended in the nutritional counseling. Data for the primary outcome will be collected from birth records and from surveys conducted at baseline (pre-intervention), midpoint (between 24-36 weeks gestation), and post-intervention (~8 weeks post-partum).

Conditions

Pregnancy Complications; Excessive Gestational Weight Gain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard of Care (SoC)

The SoC arm includes implementing the standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women. Additionally, participants in the SoC arm will receive $500 after delivery to be used for baby items.

Group Type: ACTIVE_COMPARATOR

Standard of Care (SoC)

Intervention Type: BEHAVIORAL

Standard recommended nutrition and gestational weight gain counseling.

Food Provision

The Food Provision arm includes the same nutritional and gestational weight gain counseling provided as standard of care. In addition, participants in the Food Provision arm will be provided with a total of $1000 during their pregnancy to be used specifically for the purchase of healthy foods.

Group Type: EXPERIMENTAL

Food Provision

Intervention Type: BEHAVIORAL

Standard recommended nutrition and gestational weight gain counseling plus food provision.

Interventions

Standard of Care (SoC)

Standard recommended nutrition and gestational weight gain counseling.

Intervention Type: BEHAVIORAL

Food Provision

Standard recommended nutrition and gestational weight gain counseling plus food provision.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Aged 16-44 years
• <= 22 weeks Pregnant
• Speak English, Spanish, or Marshallese
• Valid email address
• Resides in and plans to give birth in the state of Arkansas

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UAMS Institute for Community Health Innovation

Springdale, Arkansas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Brett Rowland

Role: CONTACT

mbrowland@uams.edu

479-713-8000

Kelsey Bounds

Role: CONTACT

krbounds@uams.edu

479-713-8000

Facility Contacts

Kelsey Bounds

Role: primary

KRBounds@uams.edu

Other Identifiers

297889

Identifier Type: -

Identifier Source: org_study_id