Gestational Diabetes MellitusNCT07165990
Produce Rx in High Risk Pregnant Mothers at Harris Health
A study testing Food is Medicine (FIM) Intervention in people with Gestational Diabetes Mellitus, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to assess the effectiveness of a "Food is Medicine" (FIM) intervention on incidence of gestational diabetes mellitus (GDM) among pregnant women at risk for GDM within the Harris Health system. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Food is Medicine (FIM) Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2025to 1 Oct 2026
- 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
- pregnant women receiving care at Harris Health clinics
- Medicaid eligible or receiving Medicaid
- <=14 weeks gestation at the time of the first prenatal visit and study enrollment
- meet the ACOG criteria for early screening for GDM (have a BMI of 30 or greater and at least one additional ACOG-designated risk factor for GDM from the following: Age > 35 years; Black, Hispanic, Native American, Asian American or Pacific Islander ethnicity; history of GDM in prior pregnancy; A1c level > 5.7 \& < 6.4; history of hypertension, pregnancy hypertension, heart disease, HIV, high triglycerides, polycystic ovarian syndrome; Immediate family member (parent or sibling) has had diabetes)
- fall within the study delivery radius
Who cannot join
- report existing or pregestational T2DM
- have hemoglobin A1c>=7
- are prescribed insulin therapy or metformin upon first screening
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
The University of Texas Health Science Center at Houston
Houston, Texas, 77006
Shreela Sharma, PhD, (713) 500-9344, Shreela.V.Sharma@uth.tmc.edu
About this study
The purpose of this study is to assess the effectiveness of a "Food is Medicine" (FIM) intervention on incidence of gestational diabetes mellitus (GDM) among pregnant women at risk for GDM within the Harris Health system.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Food is Medicine (FIM) Intervention, Standard of Care
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food is Medicine (FIM) InterventionBehavioural
Intensive intervention phase - this phase starts at enrollment (<=14 weeks) through 28 weeks of gestation (or at the time of GDM diagnostic test) and women i) receive a bi-weekly home delivery of a "mixed box" consisting of fresh produce, lean protein, and whole grains combined with culinary medicine-based nutrition education available in English and Spanish.
Maintenance phase - this phase starts at 29 weeks through 12 weeks postpartum, and women will receive biweekly deliveries of about 10-15 pounds of fresh produce (8-10 different kinds of produce) plus standard nutrition education. The box will be curated for prenatal nutrients needs and following American Diabetes Association guidelines.
Standard of CareBehavioural
Standard medical care provided at Harris Health for high-risk pregnant women, plus a voucher equal to the value of the produce and meals provided in the Food is Medicine (FIM) Intervention.
| Study group | Role | What they receive |
|---|---|---|
| Food is Medicine (FIM) Intervention plus Standard of Care | Experimental | Not described Receives: Behavioral: Food is Medicine (FIM) Intervention; Behavioral: Standard of Care |
| Standard of Care | Active comparator | Not described Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with gestational diabetes mellitus (GDM)
Measured: 24-28 weeks gestational age (about 10-12 weeks after start of the intervention)
Secondary outcomes (5)
Number of participants with hypertensive disorders of pregnancy
Measured: 24-28 weeks gestational age (about 10 weeks after start of the intervention)
Number of infants with macrosomia at birth
Measured: at the time of birth
Number of infants with pre-term birth
Measured: at the time of birth
Number of infants born via C-section
Measured: at the time of birth
Change in Hemoglobin A1c levels
Measured: at the time of the first prenatal visit, at the time of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start8 Sep 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shreela V Sharma, The University of Texas Health Science Center, Houston
- Investigators
- Shreela Sharma, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165990
- Sponsor's protocol ID
- HSC-SPH-23-0734 (phase 3)
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Macias-Navarro L, Ranjit N, Bounds GW, Providence BA, Shmaitelly Y, Tice NM, Sharma SV. A Bilingual AI-Based Chatbot for Nutrition Education in a Food Is Medicine Intervention for High-Risk Pregnant Women: Design and Development Study. JMIR Form Res. 2026 May 1;10:e85292. doi: 10.2196/85292.
PubMed 42066287
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Produce Rx in High Risk Pregnant Mothers at Harris Health
- ClinicalTrials.gov ID
- NCT07165990
- Acronym / sponsor ID
- HSC-SPH-23-0734 (phase 3)
- Conditions
- Gestational Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 8 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 10 Sep 2025 (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.
The purpose of this study is to assess the effectiveness of a "Food is Medicine" (FIM) intervention on incidence of gestational diabetes mellitus (GDM) among pregnant women at risk for GDM within the Harris Health system.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food is Medicine (FIM) Intervention plus Standard of Care | Experimental | Behavioral: Food is Medicine (FIM) Intervention, Behavioral: Standard of Care |
| Standard of Care | Active comparator | Behavioral: Standard of Care |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- pregnant women receiving care at Harris Health clinics
- Medicaid eligible or receiving Medicaid
- <=14 weeks gestation at the time of the first prenatal visit and study enrollment
- meet the ACOG criteria for early screening for GDM (have a BMI of 30 or greater and at least one additional ACOG-designated risk factor for GDM from the following: Age > 35 years; Black, Hispanic, Native American, Asian American or Pacific Islander ethnicity; history of GDM in prior pregnancy; A1c level > 5.7 \& < 6.4; history of hypertension, pregnancy hypertension, heart disease, HIV, high triglycerides, polycystic ovarian syndrome; Immediate family member (parent or sibling) has had diabetes)
- fall within the study delivery radius
Key exclusion criteria (3 listed)
- report existing or pregestational T2DM
- have hemoglobin A1c>=7
- are prescribed insulin therapy or metformin upon first screening
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 |
|---|---|---|
| Food is Medicine (FIM) InterventionIntensive intervention phase - this phase starts at enrollment (<=14 weeks) through 28 weeks of gestation (or at the time of GDM diagnostic test) and women i) receive a bi-weekly home delivery of a "mixed box" consisting of fresh produce, lean protein, and whole grains combined with culinary medicine-based nutrition education available in English and Spanish. Maintenance phase - this phase starts at 29 weeks through 12 weeks postpartum, and women will receive biweekly deliveries of about 10-15 pounds of fresh produce (8-10 different kinds of produce) plus standard nutrition education. The box will be curated for prenatal nutrients needs and following American Diabetes Association guidelines. | Behavioural | Food is Medicine (FIM) Intervention plus Standard of Care |
| Standard of CareStandard medical care provided at Harris Health for high-risk pregnant women, plus a voucher equal to the value of the produce and meals provided in the Food is Medicine (FIM) Intervention. | Behavioural | Food is Medicine (FIM) Intervention plus Standard of Care, Standard of Care |
Primary outcome
Number of participants with gestational diabetes mellitus (GDM)
Time frame: 24-28 weeks gestational age (about 10-12 weeks after start of the intervention)
5 secondary outcomes
Number of participants with hypertensive disorders of pregnancy
Time frame: 24-28 weeks gestational age (about 10 weeks after start of the intervention)
Number of infants with macrosomia at birth
Time frame: at the time of birth
Number of infants with pre-term birth
Time frame: at the time of birth
Number of infants born via C-section
Time frame: at the time of birth
Change in Hemoglobin A1c levels
Time frame: at the time of the first prenatal visit, at the time of birth
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 10 Sep 2025.
- Derived from this study: PubMed 42066287Macias-Navarro L, Ranjit N, Bounds GW, Providence BA, Shmaitelly Y, Tice NM, Sharma SV. A Bilingual AI-Based Chatbot for Nutrition Education in a Food Is Medicine Intervention for High-Risk Pregnant Women: Design and Development Study. JMIR Form Res. 2026 May 1;10:e85292. doi: 10.2196/85292.
- Individual participant dataSharing planned: No
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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.
Shreela Sharma, 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 Food is Medicine (FIM) Intervention in people with Gestational Diabetes Mellitus, 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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 10 Sep 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 Shreela Sharma, PhD ((713) 500-9344, Shreela.V.Sharma@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with gestational diabetes mellitus (GDM) (time frame: 24-28 weeks gestational age (about 10-12 weeks after start of the intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07165990, which also lists 1 linked publication.
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 10 Sep 2025.