Enhancing the Effectiveness of Home-delivery Based Produce Prescription Program Implementation Strategies

The University of Texas System (UT)

Status: Not yet enrolling

Conditions: Nutritional Deficiency in Pregnancy

Treatments: Behavioral: Produce Prescription Program (PPRx) Standard; Behavioral: Smartphone App

Study type: Interventional

Funder types: Other

Identifiers

NCT06114199

HSC-SPH-23-0734 (substudy)

Details and patient eligibility

About

Harris Health System is currently participating, along with two other partners, GoldiFresh Inc., and Brighter Bites, in a cross-sector collaborative home delivery-based Produce Prescription Program (PPRx) pilot initiative that provides consistent access to healthy food plus nutrition education to Medicaid-eligible pregnant women in Harris County, TX, deemed to be at high risk of adverse pregnancy or birth outcomes. The objectives of this study are two-fold: (a) to examine utilization of food basket contents and improvements in diet quality in this home delivery based PPRx program, and (b) to evaluate if and the extent to which utilization of food basket contents outcomes improves with support from an interactive AI-based conversational agent to convert food into healthy meals.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• receiving prenatal care at high-risk obstetric clinics
• <= 20 weeks medically-confirmed viable pregnancy
• designated as high risk [Age>=35 years, or obese or overweight (BMI>=25.0 at pre pregnancy self-report), or prior history of pregnancy hypertension or gestational diabetes]
• within the zip code delivery radius

Exclusion criteria

• women who were medically recommended bed rest through pregnancy
• substance users

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Produce Prescription Program (PPRx) Standard

Active Comparator group

Description:

Participants will receive biweekly deliveries of 20 lbs (\~50 servings) of fresh produce (8-10 different kinds of produce) plus standard nutrition education materials consisting of nutrition education infographics inside of the produce prescription boxes as well as online videos, recipes, and nutrition tips accessed via Quick Response (QR) code.

Treatment:

Behavioral: Produce Prescription Program (PPRx) Standard

Produce Prescription Program (PPRx) Standard plus Smartphone App

Experimental group

Description:

Participants will receive biweekly deliveries of 20 lbs (\~50 servings) of fresh produce (8-10 different kinds of produce) plus the same standard nutrition education materials provided to the control group consisting of nutrition education infographics inside of the produce prescription boxes as well as online videos, recipes, and nutrition tips accessed via Quick Response (QR) code. Additionally, participants will be given access to a smartphone app that allows women to interact with an artificial intelligence (AI) chatbot to obtain real-time cooking suggestions.

Treatment:

Behavioral: Produce Prescription Program (PPRx) Standard

Behavioral: Smartphone App