Food Provision in Prenatal Care (FPPC)

University of Arkansas

Status: Enrolling

Conditions: Excessive Gestational Weight Gain; Pregnancy Complications

Treatments: Behavioral: Standard of Care (SoC); Behavioral: Food Provision

Study type: Interventional

Funder types: Other

Identifiers

NCT06711627

297889

Details and patient eligibility

About

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).

Enrollment: 400 estimated patients

Sex: Female

Ages: 16 to 44 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

400 participants in 2 patient groups

Standard of Care (SoC)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard of Care (SoC)

Food Provision

Experimental group

Description:

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.

Treatment:

Behavioral: Food Provision