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NCT Number: NCT06114199

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.

Recruiting

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Key information

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Nanlini Ranjit, PhD

CONTACT

[email protected]

(512) 391-2527

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Produce Prescription Program (PPRx) Standard

Behavioral

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

Behavioral

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 outcomes

  1. 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

    7 point rating scale ranging from 0=none to 6=all, assessing what proportion of delivered produce was consumed over the past two weeks.

  2. 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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Nalini Ranjit, PhD

CONTACT

[email protected]

(512) 391-2527

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • American Heart Association

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 2, 2023
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.