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

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.

Study Overview

• Status: Recruiting
• Conditions: Nutritional Deficiency in Pregnancy
• Intervention / Treatment: Behavioral: Produce Prescription Program (PPRx) Standard; Behavioral: Smartphone App

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nalini Ranjit, PhD; Phone Number: (512) 391-2527; Email: Nalini.Ranjit@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Nanlini Ranjit, PhD; Phone Number: (512) 391-2527; Email: Nalini.Ranjit@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.	Behavioral: 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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in consumption of home-delivered produce from baseline to 6 months	7 point rating scale ranging from 0=none to 6=all, assessing what proportion of delivered produce was consumed over the past two weeks.	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	Fruit and vegetable consumption scale, measured by NCI dietary screener. Scale includes multiple sources of fruit and vegetables in diet, and is scored in terms of cups of fruit / day, and cups of vegetables / day	Measures will be collected at baseline, and after 6 months of exposure to program

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Nanlini Ranjit, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2024
• Primary Completion (Estimated): November 25, 2025
• Study Completion (Estimated): November 25, 2025

Study Registration Dates

• First Submitted: October 27, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): July 15, 2025
• Last Update Submitted That Met QC Criteria: July 9, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: HSC-SPH-23-0734 (substudy)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: At the end of the project, de-identified data at individual level will be uploaded to the American Heart Association (AHA) Precision-Medicine Platform.
• IPD Sharing Time Frame: September 30, 2024
• IPD Sharing Access Criteria: Will be determined by AHA.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No