Feasibility and Impact of the FOOD4MOMS Produce Prescription Program Among Pregnant Latina Women

Food Insecurity Clinical Trial

— FOOD4MOMS  

Official title:

Feasibility and Impact of the FOOD4MOMS Produce Prescription Program Among Pregnant Latina Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05907616
• Other study ID #: 2000034840
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: July 2024

Study information

• Verified date: October 2023
• Source: Yale University
• Contact: Rafael Pérez-Escamilla, PhD
• Phone: 8608052502
• Email: rafael.perez-escamilla[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Food Insecurity
• Food Preferences
• Food Selection

Intervention

Behavioral:
• Produce purchase incentive
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.

Locations

Country	Name	City	State
United States	Hispanic Health Council	Hartford	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	Hispanic Health Council, Inc., Wholesome Wave

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline and month 10
Primary	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.	baseline and month 10
Secondary	Change in household food insecurity	Change in household food insecurity assessed using a self-report survey. Less food insecurity indicates a positive outcome.	baseline and month 10