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RecruitingNCT06114199Updated Jul 15, 2025

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

An interventional study of Produce Prescription Program (PPRx) Standard and Smartphone App in Nutritional Deficiency in Pregnancy, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 44 Years. Per ClinicalTrials.gov, last updated 2025-07-15.

Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Nov 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Jul 2024; still recruiting 2 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 44 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Nutritional Deficiency in Pregnancy
03

In context

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 44 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • women who were medically recommended bed rest through pregnancy
  • substance users
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study 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.

    Behavioral: Produce Prescription Program (PPRx) Standard

  • 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 · Behavioral: Smartphone App

Interventions

  • BehavioralProduce 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.

  • BehavioralSmartphone 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Measures will be collected at baseline, and 6 times at random intervals over the next 6 months

  2. 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

    Time frame: Measures will be collected at baseline, and after 6 months of exposure to program

07

Study locations

1 of 1 sites recruiting
  • The University of Texas Health Science Center at Houston
    Houston, Texas 77030, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — At the end of the project, de-identified data at individual level will be uploaded to the American Heart Association (AHA) Precision-Medicine Platform.

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06114199
Lead sponsor
The University of Texas Health Science Center, Houston
Collaborators
American Heart Association
Responsible party
Nalini Ranjit (Associate Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Nov 2, 2023
Start date
Jul 26, 2024
Primary completion
Nov 25, 2025 (estimated)
Completion
Nov 25, 2025 (estimated)
Last update
Jul 15, 2025

Study contacts

Nalini Ranjit, PhD
Contact
Nalini.Ranjit@uth.tmc.edu
(512) 391-2527
Nanlini Ranjit, PhD
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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