- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05907616
Feasibility and Impact of the FOOD4MOMS Produce Prescription Program Among Pregnant Latina Women (FOOD4MOMS)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Connecticut
-
Hartford, Connecticut, United States, 06106
- Hispanic Health Council
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Any individual not meeting any of this criterion will be excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: pregnant Latina women
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
baseline and month 10
|
|
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.
|
baseline and month 10
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in household food insecurity
Time Frame: baseline and month 10
|
Change in household food insecurity assessed using a self-report survey.
Less food insecurity indicates a positive outcome.
|
baseline and month 10
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rafael Pérez-Escamilla, PhD, Yale University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000034840
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Food Insecurity
-
Wake Forest University Health SciencesRecruitingFood InsecurityUnited States
-
Washington University School of MedicineBJC HealthCare; Schnuck Markets, Inc.Completed
-
Vanderbilt University Medical CenterCompleted
-
University of CalgaryCanadian Institutes of Health Research (CIHR); British Columbia Farmers' Market... and other collaboratorsCompleted
-
University of ChicagoNational Institute on Minority Health and Health Disparities (NIMHD)Completed
-
Children's Hospital of PhiladelphiaUniversity of Pennsylvania; McClay Foundation; The Leo and Peggy Pierce Family...Completed
-
Stanford UniversityCompleted
-
Rhode Island HospitalUniversity of Rhode IslandCompleted
-
Purdue UniversityUniversity of Kentucky Center for Poverty Research; North Central Nutrition...Completed
-
NYU Langone HealthNational Center for Advancing Translational Sciences (NCATS)RecruitingFood InsecurityUnited States
Clinical Trials on Produce purchase incentive
-
Wake Forest University Health SciencesNational Institute on Drug Abuse (NIDA)Completed
-
University of OregonRecruiting
-
Tufts UniversityNational Association of Chain Drug StoresNot yet recruitingHypertension | Diabetes Mellitus Type 2
-
Universidad de AntioquiaUnknown
-
Turtle Health, Inc.WithdrawnFertility RiskUnited States
-
Gretchen Swanson Center for NutritionUniversity of Colorado, Denver; University of California, San Francisco; Children... and other collaboratorsEnrolling by invitation
-
Rutgers, The State University of New JerseyNot yet recruitingFood Insecurity | Carotenoid Status | Produce PrescriptionUnited States
-
University at BuffaloAmerican Heart AssociationCompletedFood Preferences | Food HabitsUnited States
-
University of HawaiiNational Institute on Minority Health and Health Disparities (NIMHD)Not yet recruiting