Food SelectionFOOD4MOMSNCT05907616
Feasibility and Impact of the FOOD4MOMS Produce Prescription Program Among Pregnant Latina Women
A study testing Produce purchase incentive in people with Food Selection and Food Preferences, run by Yale University at 1 site in United States.
Trial summary
The study will include women enrolled during the second trimester of pregnancy who will be provided with a specific amount per month for 10 months to purchase produce. Women will be provided with up to three nutrition education sessions and will be sent text message reminders to redeem their incentives every month and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Food Selection, Food Preferences, Food Insecurity
- What is being tested?
- Produce purchase incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- during first or second trimester of pregnancy
- live in the city of Hartford
- low income (participating or enrolled in WIC, SNAP or Medicaid)
- speak English or Spanish.
Who cannot join
- Any individual not meeting any of this criterion will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hispanic Health Council
Hartford, Connecticut, 06106
About this study
The study will include women enrolled during the second trimester of pregnancy who will be provided with a specific amount per month for 10 months to purchase produce. Women will be provided with up to three nutrition education sessions and will be sent text message reminders to redeem their incentives every month and to provide them with nutrition tips. The study will use a co-design approach to utilize feedback from potential participants as well as participants at multiple time points in the process to improve the intervention and make it more relevant and impactful to our population.
Read the detailed description
This protocol describes the implementation of an intervention to improve access to fruits and vegetables among pregnant Latina women in Hartford CT in partnership with Wholesome Wave of Bridgeport CT, a national leader in nutrition incentive programming and policy.
The target population are pregnant Latina women living in Hartford CT. Having access to the right foods as well as enough food during pregnancy promotes optimal fetal development. A prescription program that provides increased fruit and vegetable access to low-income pregnant women can help improve the diet of women during pregnancy.
Nutrition education sessions (either virtual or in person) will be attended by all participants with one session required and up to two additional sessions optional.
Fruits and vegetables may be purchased at diverse community locations or online for home delivery.
- Conditions
- Food Selection, Food Preferences, Food Insecurity
- Being tested
- Produce purchase incentive
- Medical subject headings
- Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Produce purchase incentiveBehavioural
Participants will be provided with a specific incentive amount per month for 10 months to purchase produce, nutrition education sessions and will be sent text message reminders to redeem their incentives every month and to provide them with nutrition tips.
| Study group | Role | What they receive |
|---|---|---|
| pregnant Latina women | Experimental | Pregnant Latina women in Hartford CT enrolled during the first or second trimester of pregnancy. Participants will be provided with up to three nutrition education sessions and will be sent text message reminders to redeem their incentives every month and to provide them with nutrition tips. Receives: Behavioral: Produce purchase incentive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in amount of produce purchased or accessed
The amount of produce purchased or accessed will be asses using a self-report survey. An increase in produce purchased or accessed indicates a positive outcome.
Measured: baseline and month 10
Change in Produce Intake
Change in Produce Intake will be assessed using a self-report survey. An increase in produce intake indicates a positive outcome.
Measured: baseline and month 10
Secondary outcomes (1)
Change in household food insecurity
Change in household food insecurity assessed using a self-report survey. Less food insecurity indicates a positive outcome.
Measured: baseline and month 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Aug 2023
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
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 Food SelectionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Wholesome Wave, Hispanic Health Council, Inc.
- Responsible party
- Sponsor
- Investigators
- Rafael Pérez-Escamilla, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907616
- Sponsor's protocol ID
- 2000034840
- Acronym
- FOOD4MOMS
- Status last verified
- Mar 2026
- First submitted
- 7 Jun 2023
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Segura-Perez S, Gionteris K, Hromi-Fiedler A, O'Connor Duffany K, Rhodes EC, Rodonis S, Aleaga-Figueroa A, Galdamez G, Tristan Urrutia A, Perez-Escamilla R. Impact of the Food4Moms produce prescription program on readiness for healthy eating, fruit and vegetable intake, and food security. PLoS One. 2026 Sep 2;21(9):e0348968. doi: 10.1371/journal.pone.0348968. eCollection 2026.
PubMed 42685025
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Impact of the FOOD4MOMS Produce Prescription Program Among Pregnant Latina Women
- ClinicalTrials.gov ID
- NCT05907616
- Acronym / sponsor ID
- FOOD4MOMS / 2000034840
- Conditions
- Food Selection, Food Preferences, Food Insecurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Wholesome Wave, Hispanic Health Council, Inc.
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 18 Jun 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.
The study will include women enrolled during the second trimester of pregnancy who will be provided with a specific amount per month for 10 months to purchase produce. Women will be provided with up to three nutrition education sessions and will be sent text message reminders to redeem their incentives every month and to provide them with nutrition tips. The study will use a co-design approach to utilize feedback from potential participants as well as participants at multiple time points in the process to improve the intervention and make it more relevant and impactful to our population.
Detailed description
This protocol describes the implementation of an intervention to improve access to fruits and vegetables among pregnant Latina women in Hartford CT in partnership with Wholesome Wave of Bridgeport CT, a national leader in nutrition incentive programming and policy.
The target population are pregnant Latina women living in Hartford CT. Having access to the right foods as well as enough food during pregnancy promotes optimal fetal development. A prescription program that provides increased fruit and vegetable access to low-income pregnant women can help improve the diet of women during pregnancy.
Nutrition education sessions (either virtual or in person) will be attended by all participants with one session required and up to two additional sessions optional.
Fruits and vegetables may be purchased at diverse community locations or online for home delivery.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pregnant Latina women | Experimental | Behavioral: Produce purchase incentivePregnant Latina women in Hartford CT enrolled during the first or second trimester of pregnancy. Participants will be provided with up to three nutrition education sessions and will be sent text message reminders to redeem their incentives every month and to provide them with nutrition tips. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- during first or second trimester of pregnancy
- live in the city of Hartford
- low income (participating or enrolled in WIC, SNAP or Medicaid)
- speak English or Spanish.
Key exclusion criteria (1 listed)
- Any individual not meeting any of this criterion will be excluded from the study.
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 purchase incentiveParticipants will be provided with a specific incentive amount per month for 10 months to purchase produce, nutrition education sessions and will be sent text message reminders to redeem their incentives every month and to provide them with nutrition tips. | Behavioural | pregnant Latina women |
Primary outcome
Change in amount of produce purchased or accessed
Time frame: baseline and month 10
The amount of produce purchased or accessed will be asses using a self-report survey. An increase in produce purchased or accessed indicates a positive outcome.
Change in Produce Intake
Time frame: baseline and month 10
Change in Produce Intake will be assessed using a self-report survey. An increase in produce intake indicates a positive outcome.
1 secondary outcome
Change in household food insecurity
Time frame: baseline and month 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Derived from this study: PubMed 42685025Segura-Perez S, Gionteris K, Hromi-Fiedler A, O'Connor Duffany K, Rhodes EC, Rodonis S, Aleaga-Figueroa A, Galdamez G, Tristan Urrutia A, Perez-Escamilla R. Impact of the Food4Moms produce prescription program on readiness for healthy eating, fruit and vegetable intake, and food security. PLoS One. 2026 Sep 2;21(9):e0348968. doi: 10.1371/journal.pone.0348968. eCollection 2026.
- 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. This study is not recruiting at the moment.
Rafael Pérez-Escamilla, PhD principal investigator
Yale University
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 purchase incentive in people with Food Selection and Food Preferences, run by Yale University 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 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: finished, as of the sponsor's last update on 16 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in amount of produce purchased or accessed (time frame: baseline and month 10). 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?
On the ClinicalTrials.gov record for NCT05907616, 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 16 Mar 2026.