Recruiting

Produce Prescription Program

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06114199

Conditions

Nutritional Deficiency in Pregnancy

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Not accepted

Interventions

Produce Prescription Program (PPRx) Standard

Smartphone App

Study Details

Brief summary:

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.

Conditions

Nutritional Deficiency in Pregnancy

Study ID

NCT06114199

Start date

Jul 26, 2024

Status verified date

Jul, 2025

Completion date

Nov 25, 2025

Anticipated

Primary completion date

Nov 25, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Produce Prescription Program (PPRx) Standard

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.

experimental: Produce Prescription Program (PPRx) Standard plus Smartphone App

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.

Interventions

Produce Prescription Program (PPRx) Standard

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.

Smartphone App

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.

Primary outcome measure

  • Change in consumption of home-delivered produce from baseline to 6 months [ Time Frame: Measures will be collected at baseline, and 6 times at random intervals over the next 6 months ]
  • Change in usual consumption of fruits and vegetables from baseline to 6 months [ Time Frame: Measures will be collected at baseline, and after 6 months of exposure to program ]

Central Contacts and Locations

Central contacts

Nalini Ranjit, PhD

(512) 391-2527Nalini.Ranjit@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Nanlini Ranjit, PhD

(512) 391-2527Nalini.Ranjit@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Jul 15, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2025-07-15.