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Recruiting NCT06114199

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

No phase Interventional Nutritional Deficiency in Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Produce Prescription Program (PPRx) Standard, Smartphone App.
Who it may be relevant to
Registry conditions: Nutritional Deficiency in Pregnancy. Basic parameters: 18 years — 44 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT06114199 · HSC-SPH-23-0734 (substudy)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗