Enhancing the Effectiveness of Home-delivery Based Produce Prescription Program Implementation Strategies
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2023
CompletedFirst Posted
Study publicly available on registry
November 2, 2023
CompletedStudy Start
First participant enrolled
July 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2025
CompletedJuly 15, 2025
July 1, 2025
1.3 years
October 27, 2023
July 9, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Produce Prescription Program (PPRx) Standard
ACTIVE COMPARATORParticipants 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.
Produce Prescription Program (PPRx) Standard plus Smartphone App
EXPERIMENTALParticipants 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
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- women who were medically recommended bed rest through pregnancy
- substance users
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Nanlini Ranjit, PhD
The University of Texas Health Science Center, Houston
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 27, 2023
First Posted
November 2, 2023
Study Start
July 26, 2024
Primary Completion
November 25, 2025
Study Completion
November 25, 2025
Last Updated
July 15, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- September 30, 2024
- Access Criteria
- Will be determined by AHA.
At the end of the project, de-identified data at individual level will be uploaded to the American Heart Association (AHA) Precision-Medicine Platform.