Nutritional Deficiency in PregnancyNCT06114199
Enhancing the Effectiveness of Home-delivery Based Produce Prescription Program Implementation Strategies
A study testing Produce Prescription Program (PPRx) Standard and Smartphone App in people with Nutritional Deficiency in Pregnancy, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Nutritional Deficiency in Pregnancy
- What is being tested?
- Produce Prescription Program (PPRx) Standard and Smartphone App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2024to 25 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- women who were medically recommended bed rest through pregnancy
- substance users
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Nanlini Ranjit, PhD, (512) 391-2527, Nalini.Ranjit@uth.tmc.edu
About this study
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.
- Conditions
- Nutritional Deficiency in Pregnancy
- Being tested
- Produce Prescription Program (PPRx) Standard, Smartphone App
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Produce Prescription Program (PPRx) StandardBehavioural
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 AppBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Produce Prescription Program (PPRx) Standard | Active comparator | 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. Receives: Behavioral: Produce Prescription Program (PPRx) Standard |
| Produce Prescription Program (PPRx) Standard plus Smartphone App | Experimental | 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. Receives: Behavioral: Produce Prescription Program (PPRx) Standard; Behavioral: Smartphone App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Measures will be collected at baseline, and after 6 months of exposure to program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start26 Jul 2024
- Primary completion25 Nov 2025 (estimated)
- Study completion25 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional Deficiency in PregnancyStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Nalini Ranjit, The University of Texas Health Science Center, Houston
- Investigators
- Nanlini Ranjit, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114199
- Sponsor's protocol ID
- HSC-SPH-23-0734 (substudy)
- Status last verified
- Jul 2025
- First submitted
- 27 Oct 2023
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the end of the project, de-identified data at individual level will be uploaded to the American Heart Association (AHA) Precision-Medicine Platform.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Effectiveness of Home-delivery Based Produce Prescription Program Implementation Strategies
- ClinicalTrials.gov ID
- NCT06114199
- Acronym / sponsor ID
- HSC-SPH-23-0734 (substudy)
- Conditions
- Nutritional Deficiency in Pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- 25 Nov 2025 (estimated)
- Study completion
- 25 Nov 2025 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Produce Prescription Program (PPRx) Standard | Active comparator | Behavioral: Produce Prescription Program (PPRx) StandardParticipants 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 | Experimental | Behavioral: Produce Prescription Program (PPRx) Standard, Behavioral: Smartphone AppParticipants 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. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- women who were medically recommended bed rest through pregnancy
- substance users
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Produce Prescription Program (PPRx) StandardParticipants 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. | Behavioural | Produce Prescription Program (PPRx) Standard, Produce Prescription Program (PPRx) Standard plus Smartphone App |
| Smartphone AppParticipants 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. | Behavioural | Produce Prescription Program (PPRx) Standard plus Smartphone App |
Primary outcome
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: Yes. At the end of the project, de-identified data at individual level will be uploaded to the American Heart Association (AHA) Precision-Medicine Platform.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nanlini Ranjit, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Produce Prescription Program (PPRx) Standard and Smartphone App in people with Nutritional Deficiency in Pregnancy, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nalini Ranjit, PhD ((512) 391-2527, Nalini.Ranjit@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.