NCT05907616

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

June 7, 2023

Last Update Submit

March 13, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Change in household food insecurity

    baseline and month 10

Study Arms (1)

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.

Behavioral: Produce purchase incentive

Interventions

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.

pregnant Latina women

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Any individual not meeting any of this criterion will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hispanic Health Council

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Conditions

Food Preferences

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Rafael Pérez-Escamilla, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2023

First Posted

June 18, 2023

Study Start

August 1, 2023

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations