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

Study Overview
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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.

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

Conditions
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Nutritional Deficiency in Pregnancy

Intervention / Treatment
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* Behavioral: Produce Prescription Program (PPRx) Standard
* Behavioral: Smartphone App


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Produce Prescription Program (PPRx) Standard<br>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<br>* 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.<br>|
| Experimental: Produce Prescription Program (PPRx) Standard plus Smartphone App<br>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<br>* 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.<br>Behavioral: Smartphone App<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |