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

NCT ID: NCT06114199

Last Updated: 2025-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-26

Study Completion Date

2025-11-25

Brief Summary

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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.

Detailed Description

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Conditions

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Nutritional Deficiency in Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Produce Prescription Program (PPRx) Standard

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Produce Prescription Program (PPRx) Standard

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Nalini Ranjit

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nanlini Ranjit, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nalini Ranjit, PhD

Role: CONTACT

(512) 391-2527

Facility Contacts

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Nanlini Ranjit, PhD

Role: primary

(512) 391-2527

Other Identifiers

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HSC-SPH-23-0734 (substudy)

Identifier Type: -

Identifier Source: org_study_id

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