NCT04652596

Brief Summary

This study aims to compare the effectiveness of two interventions to address food insecurity among low-income families with young children during the COVID pandemic. The investigators will conduct a parallel group, randomized controlled trial of 250 families. The first randomly assigned comparator is Fresh Connect, a produce prescription program that provides a stipend for participants to purchase fresh food items at mobile markets and independent farmers markets across Boston. The second comparator is grocery store gift cards, redeemable at conventional grocery stores. In each comparator, participants will be given the equivalent of $150 on a monthly basis for six consecutive months. All participants will be followed for 12 months to assess outcomes that involve food insecurity (primary), fruit and vegetable consumption, healthcare utilization, social service utilization, and physical/emotional health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

February 8, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2023

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

November 30, 2020

Last Update Submit

April 25, 2023

Conditions

Food Insecurity

Keywords

Produce prescription programMobile marketsGrocery store gift cardsFruit and vegetable consumptionLow-income familiesSocial determinants of health

Outcome Measures

Primary Outcomes (1)

  • Change in Food Security

    Self-reported food security status measured by USDA validated 18-question food insecurity screening tool with a 30-day lookback period. Responses are scored with total scores corresponding to four categories: high food security, marginal food security, low food security, and very low food security

    Baseline, monthly for 12-months post-enrollment

Secondary Outcomes (20)

  • Change in fruit & vegetable consumption

    Baseline, monthly for 12 months post-enrollment

  • Depression Symptoms

    Baseline, monthly for 12-months post-enrollment

  • Symptom Relief

    Baseline, monthly for 12-months post-enrollment

  • Changes of behavioral activation for depression

    Baseline, every 6 months during 12 month post-enrollment

  • Perceived Stress

    Baseline, every 6 months during 12 month post-enrollment

  • +15 more secondary outcomes

Study Arms (2)

Fresh Connect Produce Prescription Program

ACTIVE COMPARATOR

Investigators will partner with a community organization, About Fresh, that administers a produce prescription program (PPR) and operates mobile fresh foods markets. Participants randomized to this comparator will receive a stipend to Fresh Connect PPR to purchase fresh food items available at mobile markets and at independent farmers markets throughout Boston.

Other: Produce prescription program

Grocery store gift cards

ACTIVE COMPARATOR

Participants randomized to this comparator will receive grocery gift cards redeemable at conventional grocery stores.

Other: Grocery store gift cards

Interventions

Produce prescription programOTHER

A monthly $150 stipend will be provided to participants for 6 consecutive months to purchase fresh food items at mobile markets and independent farmers markets across Boston.

Also known as: Fresh Connect
Fresh Connect Produce Prescription Program
Grocery store gift cardsOTHER

A monthly value of $150 in grocery store gift cards redeemable at conventional grocery stores will be provided to participants for 6 consecutive months.

Grocery store gift cards

Eligibility Criteria

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

You may qualify if:

  • Parent of a child 0-18 months of age
  • Child receives care at Boston Medical Center

You may not qualify if:

  • Planning to move residence outside of Boston within 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Study Officials

  • Kelsey A Egan, MD MSc

    Boston Medical Center Department of Pediatrics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2020

First Posted

December 3, 2020

Study Start

February 8, 2021

Primary Completion

February 13, 2023

Study Completion

February 13, 2023

Last Updated

April 27, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)