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Behavioral Intervention
Produce Prescription + Smartphone Support for Pregnancy Nutrition
N/A
Waitlist Available
Led By Nanlini Ranjit, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measures will be collected at baseline, and after 6 months of exposure to program
Awards & highlights
Study Summary
This trial is helping pregnant women in Harris County, Texas get access to healthy food plus nutrition education. It's also studying if AI-based chatbot support can help them turn food into healthy meals.
Who is the study for?
This trial is for Medicaid-eligible pregnant women in Harris County, TX who are at high risk of poor pregnancy or birth outcomes. They must be receiving care at high-risk obstetric clinics, less than 20 weeks into a viable pregnancy, and live within the delivery area. High risk factors include being over 35 years old, overweight or obese, or having had hypertension or diabetes in previous pregnancies.Check my eligibility
What is being tested?
The study tests a home-delivery Produce Prescription Program (PPRx) that provides healthy food and nutrition education to participants. It aims to see if this improves diet quality and whether an AI-based smartphone app can help them better use their food baskets to make healthy meals.See study design
What are the potential side effects?
Since this trial involves nutritional support rather than medication, there aren't typical side effects like with drugs. However, changes in diet may cause digestive adjustments. The smartphone app might also lead to increased screen time which could affect sleep patterns.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measures will be collected at baseline, and 6 times at random intervals over the next 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measures will be collected at baseline, and 6 times at random intervals over the next 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in consumption of home-delivered produce from baseline to 6 months
Change in usual consumption of fruits and vegetables from baseline to 6 months
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Produce Prescription Program (PPRx) Standard plus Smartphone AppExperimental Treatment2 Interventions
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 II: Produce Prescription Program (PPRx) StandardActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Smartphone App
2020
N/A
~470
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Who is running the clinical trial?
American Heart AssociationOTHER
326 Previous Clinical Trials
4,933,426 Total Patients Enrolled
The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,760 Total Patients Enrolled
Nanlini Ranjit, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are seniors eligible to join this clinical examination?
"Adherence to the eligibility criteria for this clinical trial dictates that potential participants must be between 18 and 44 years of age."
Answered by AI
Am I able to participate in this experiment?
"To qualify for this trial, applicants must have received nutrition in pregnancy and be of age between 18 to 44. The study is currently aiming to recruit 200 individuals."
Answered by AI
Is recruitment still open for this research endeavor?
"Affirmative, clinicaltrials.gov reflects that this medical trial is no longer actively recruiting patients. It was first posted on November 7th 2023 and its last edit occurred on October 27th of the same year. However, there are 1 other trials in progress at present searching for participants to take part."
Answered by AI
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