NCT05782660

Brief Summary

During the first two years of the COVID-19 pandemic, the City of Chelsea, Massachusetts held a lottery to allocate cash benefits to its residents for ten months. Using data from the Chelsea Eats program, the investigators propose to study the impact of the cash benefit on reproductive and perinatal health.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,615

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 27, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 23, 2023

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

July 12, 2024

Status Verified

July 1, 2024

Enrollment Period

1.4 years

First QC Date

March 11, 2023

Last Update Submit

July 11, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pregnancy

    Pregnancies will be identified using the electronic health record, documented with a positive urine or blood pregnancy test, ultrasound, and/or diagnosis codes over the 10 months of the trial; because pregnancy without delivery is the primary outcome for our main analysis, the investigators will then determine whether each pregnancy did or did not result in a live childbirth delivered vaginally or via Cesarean section, which can occur after the 10 months of the trial

    20 months

Secondary Outcomes (6)

  • Miscarriage

    20 months

  • Abortion

    20 months

  • Prenatal vitamin prescriptions prior to pregnancy

    10 months

  • Contraception

    10 months

  • Number and timing of prenatal visits before delivery

    20 months

  • +1 more secondary outcomes

Study Arms (2)

Treatment Group

EXPERIMENTAL

Participants in the treatment group received up to $400 per month.

Other: Cash Benefit

Control Group

ACTIVE COMPARATOR

Participants in the control group did not receive monthly cash benefits.

Other: No Cash Benefit

Interventions

Spending from the cards was not restricted to food but could be spent on anything and anywhere Visa was accepted. The debit cards were credited with the first payment on November 18th, 2020 and the second payment on December 18th, 2020. The program continued with monthly credits through August 2021.

Also known as: Basic Income, Debit Card
Treatment Group

No monthly cash benefit.

Control Group

Eligibility Criteria

Age15 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Resident of Chelsea, Massachusetts
  • Household income at or below 30% of the U.S. Department of Housing and Urban Development's Area Median Income
  • Childbearing age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harvard Medical School

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Sumit D Agarwal, MD, MPH

    Brigham and Women's Hospital and Harvard Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

March 11, 2023

First Posted

March 23, 2023

Study Start

July 27, 2020

Primary Completion

December 31, 2021

Study Completion

August 31, 2025

Last Updated

July 12, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations