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

Sponsor
Yale University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05907616
Collaborator
Wholesome Wave (Other), Hispanic Health Council, Inc. (Other)
150
1
1
12
12.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Produce purchase incentive
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Feasibility and Impact of the FOOD4MOMS Produce Prescription Program Among Pregnant Latina Women
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Change in amount of produce purchased or accessed [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.

  2. Change in Produce Intake [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.

Secondary Outcome Measures

  1. Change in household food insecurity [baseline and month 10]

    Change in household food insecurity assessed using a self-report survey. Less food insecurity indicates a positive outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hispanic Health Council Hartford Connecticut United States 06106

Sponsors and Collaborators

  • Yale University
  • Wholesome Wave
  • Hispanic Health Council, Inc.

Investigators

  • Principal Investigator: Rafael PĂ©rez-Escamilla, PhD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT05907616
Other Study ID Numbers:
  • 2000034840
First Posted:
Jun 18, 2023
Last Update Posted:
Jun 18, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 18, 2023