Nutrition in High-Risk PregnancyNCT06275568
Accelerating Healthcare Engagement in Healthy Food Interventions - Food Rx in High Risk Pregnant Mothers With About Fresh and Community Health Choice
A study testing Enhanced engagement communication in people with Nutrition in High-Risk Pregnancy, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of the study is to assess if the Fresh Connect food prescription (Fresh Connect Food Rx) program that provides consistent access to healthy fresh produce through purchases at the grocery store plus nutrition education impacts gestational weight gain, other pregnancy and birth outcomes, and food and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Nutrition in High-Risk Pregnancy
- What is being tested?
- Enhanced engagement communication
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 620 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2025to 1 Dec 2027
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Less than or equal to 20 weeks medically confirmed viable pregnancy
- high-risk pregnant mothers receiving care at Community Health Choice managed care organizations in Houston, Texas (High risk may include overweight/obese pre-pregnancy or at first trimester (self-report or measured BMI>30.0), and/or prior history of diabetes or gestational diabetes, and/or prior history of hypertension or pregnancy-induced hypertension)
Who cannot join
- Does not Speak English or Spanish
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
Shreela Sharma, PhD, (713) 500-9344, Shreela.V.Sharma@uth.tmc.edu
Naomi Tice, MPH, (713) 500-9000, Naomi.Tice@uth.tmc.edu
About this study
The purpose of the study is to assess if the Fresh Connect food prescription (Fresh Connect Food Rx) program that provides consistent access to healthy fresh produce through purchases at the grocery store plus nutrition education impacts gestational weight gain, other pregnancy and birth outcomes, and food and nutrition security in low-income, ethnically diverse, at-risk women residing in Houston, Texas. Enrollment of participants will begin in pregnancy at the time of the first prenatal visit (as long as the first visit occurs before the end of the first trimester); each participant will be followed until 60 days post-partum (up to 11 months follow-up per participant).
- Conditions
- Nutrition in High-Risk Pregnancy
- Being tested
- Usual Care Fresh Connect cardholder engagement, Enhanced engagement communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Care Fresh Connect cardholder engagementBehavioural
Fresh Connect, a Food as Medicine product of the non-profit organization About Fresh, Inc., consists of a pre paid, programmable debit card, a cloud-based cardholder success platform, and an analytic engine designed to illuminate the healthcare value of improved food access and nutritional security.
This arm receives:
- About Fresh Food Rx debit card ($100 per month from enrollment until 2 months post-partum)
- Texts for all cardholders per month (1-2 outbound texts)
- Welcome call from About Fresh cardholder engagement team
- 1 text - notification that Fresh Connect funds have been reloaded
- As-needed program updates (e.g. new retailers), inactivity outreach
- Additional texts that would be ad hocs: texts with food experiences (cooking videos), produce how-tos, and fun engagement; and satisfaction surveys - e.g. feedback on the Fresh Connect program, feedback on retailers, satisfaction with cardholder success, etc.
Enhanced engagement communicationBehavioural
Enhanced engagement involves additional outbound texts per month and additional ad hoc bi-monthly or quarterly texts, as well as tailored reminder text to use funds before the end of the month.
| Study group | Role | What they receive |
|---|---|---|
| Usual care Fresh Connect cardholder engagement | Active comparator | Not described Receives: Behavioral: Usual Care Fresh Connect cardholder engagement |
| Usual care Fresh Connect cardholder engagement plus Enhanced engagement communication | Experimental | Not described Receives: Behavioral: Usual Care Fresh Connect cardholder engagement; Behavioral: Enhanced engagement communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute gestational weight gain (GWG) in pounds
Measured: From the start of the first trimester of pregnancy to the end of the first trimester of pregnancy (3 months)
Absolute gestational weight gain (GWG) in pounds
Measured: From the start of the second trimester of pregnancy to the end of the second trimester of pregnancy (3 months)
Absolute gestational weight gain (GWG) in pounds
Measured: From the start of the third trimester of pregnancy to the end of the third trimester of pregnancy (3 months)
Excess gestational weight gain (EGWG) in pounds
Measured: From the start of the first trimester of pregnancy to the end of the first trimester of pregnancy (3 months)
Excess gestational weight gain (EGWG) in pounds
Measured: From the start of the second trimester of pregnancy to the end of the second trimester of pregnancy (3 months)
Excess gestational weight gain (EGWG) in pounds
Measured: From the start of the third trimester of pregnancy to the end of the third trimester of pregnancy (3 months)
Secondary outcomes (4)
Number of participants diagnosed with pregnancy-induced hypertension
Measured: From the time of enrollment until the time of birth (up to 9 months)
Number of participants diagnosed with gestational diabetes
Measured: From the time of enrollment until the time of birth (up to 9 months)
Number of participants with pre-term birth (<37 weeks)
Measured: at the time of birth
Infant birth weight
Measured: 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 posted23 Feb 2024
- Study start3 Jul 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition in High-Risk 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 620 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, Tufts University, Michael and Susan Dell Foundation
- 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
- NCT06275568
- Sponsor's protocol ID
- HSC-SPH-23-0655
- Status last verified
- Sep 2025
- First submitted
- 3 Nov 2023
- Last updated
- 13 Jul 2026
- Results posted
- 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 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerating Healthcare Engagement in Healthy Food Interventions - Food Rx in High Risk Pregnant Mothers With About Fresh and Community Health Choice
- ClinicalTrials.gov ID
- NCT06275568
- Acronym / sponsor ID
- HSC-SPH-23-0655
- Conditions
- Nutrition in High-Risk Pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 620 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- American Heart Association, Tufts University, Michael and Susan Dell Foundation
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 23 Feb 2024 (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 the study is to assess if the Fresh Connect food prescription (Fresh Connect Food Rx) program that provides consistent access to healthy fresh produce through purchases at the grocery store plus nutrition education impacts gestational weight gain, other pregnancy and birth outcomes, and food and nutrition security in low-income, ethnically diverse, at-risk women residing in Houston, Texas. Enrollment of participants will begin in pregnancy at the time of the first prenatal visit (as long as the first visit occurs before the end of the first trimester); each participant will be followed until 60 days post-partum (up to 11 months follow-up per participant).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care Fresh Connect cardholder engagement | Active comparator | Behavioral: Usual Care Fresh Connect cardholder engagement |
| Usual care Fresh Connect cardholder engagement plus Enhanced engagement communication | Experimental | Behavioral: Usual Care Fresh Connect cardholder engagement, Behavioral: Enhanced engagement communication |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Less than or equal to 20 weeks medically confirmed viable pregnancy
- high-risk pregnant mothers receiving care at Community Health Choice managed care organizations in Houston, Texas (High risk may include overweight/obese pre-pregnancy or at first trimester (self-report or measured BMI>30.0), and/or prior history of diabetes or gestational diabetes, and/or prior history of hypertension or pregnancy-induced hypertension)
Key exclusion criteria (1 listed)
- Does not Speak English or Spanish
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 |
|---|---|---|
| Usual Care Fresh Connect cardholder engagementFresh Connect, a Food as Medicine product of the non-profit organization About Fresh, Inc., consists of a pre paid, programmable debit card, a cloud-based cardholder success platform, and an analytic engine designed to illuminate the healthcare value of improved food access and nutritional security. This arm receives: * About Fresh Food Rx debit card ($100 per month from enrollment until 2 months post-partum) * Texts for all cardholders per month (1-2 outbound texts) * Welcome call from About Fresh cardholder engagement team * 1 text - notification that Fresh Connect funds have been reloaded * As-needed program updates (e.g. new retailers), inactivity outreach * Additional texts that would be ad hocs: texts with food experiences (cooking videos), produce how-tos, and fun engagement; and satisfaction surveys - e.g. feedback on the Fresh Connect program, feedback on retailers, satisfaction with cardholder success, etc. | Behavioural | Usual care Fresh Connect cardholder engagement, Usual care Fresh Connect cardholder engagement plus Enhanced engagement communication |
| Enhanced engagement communicationEnhanced engagement involves additional outbound texts per month and additional ad hoc bi-monthly or quarterly texts, as well as tailored reminder text to use funds before the end of the month. | Behavioural | Usual care Fresh Connect cardholder engagement plus Enhanced engagement communication |
Primary outcome
Absolute gestational weight gain (GWG) in pounds
Time frame: From the start of the first trimester of pregnancy to the end of the first trimester of pregnancy (3 months)
Absolute gestational weight gain (GWG) in pounds
Time frame: From the start of the second trimester of pregnancy to the end of the second trimester of pregnancy (3 months)
Absolute gestational weight gain (GWG) in pounds
Time frame: From the start of the third trimester of pregnancy to the end of the third trimester of pregnancy (3 months)
Excess gestational weight gain (EGWG) in pounds
Time frame: From the start of the first trimester of pregnancy to the end of the first trimester of pregnancy (3 months)
Excess gestational weight gain (EGWG) in pounds
Time frame: From the start of the second trimester of pregnancy to the end of the second trimester of pregnancy (3 months)
Excess gestational weight gain (EGWG) in pounds
Time frame: From the start of the third trimester of pregnancy to the end of the third trimester of pregnancy (3 months)
4 secondary outcomes
Number of participants diagnosed with pregnancy-induced hypertension
Time frame: From the time of enrollment until the time of birth (up to 9 months)
Number of participants diagnosed with gestational diabetes
Time frame: From the time of enrollment until the time of birth (up to 9 months)
Number of participants with pre-term birth (<37 weeks)
Time frame: at the time of birth
Infant birth weight
Time frame: 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 13 Jul 2026.
- about Fresh ConnectLink provided by the sponsor.
- 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.
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 Enhanced engagement communication in people with Nutrition in High-Risk 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 2 inclusion and 1 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 13 Jul 2026. 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?
Absolute gestational weight gain (GWG) in pounds (time frame: From the start of the first trimester of pregnancy to the end of the first trimester of pregnancy (3 months)). The study lists 6 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 13 Jul 2026.