Clinical trial NCT04652596: Reducing Food Insecurity During COVID-19
Official title: Comparative Effectiveness of Two Interventions to Reduce Food Insecurity During the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Insecurity
Keywords: Produce prescription program
Mobile markets
Grocery store gift cards
Fruit and vegetable consumption
Low-income families
Social determinants of health
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: United States Department of Agriculture (USDA)
name: Krupp Family Foundation
name: Waldron Charitable Fund
First posted: 2020-12-03
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Planning to move residence outside of Boston within 12 months

Primary outcomes:
measure: Change in Food Security
timeFrame: Baseline, monthly for 12-months post-enrollment
Secondary outcomes:
measure: Change in fruit & vegetable consumption
timeFrame: Baseline, monthly for 12 months post-enrollment
measure: Depression Symptoms
timeFrame: Baseline, monthly for 12-months post-enrollment
measure: Symptom Relief
timeFrame: Baseline, monthly for 12-months post-enrollment
measure: Changes of behavioral activation for depression
timeFrame: Baseline, every 6 months during 12 month post-enrollment
measure: Perceived Stress
timeFrame: Baseline, every 6 months during 12 month post-enrollment
measure: Social Support
timeFrame: Baseline, every 6 months during 12 month post-enrollment
measure: Medical outcomes social support
timeFrame: Baseline, every 6 months during 12 month post-enrollment
measure: Mastery Control
timeFrame: Baseline, every 6 months during 12 month post-enrollment
measure: Self-Esteem
timeFrame: Baseline, every 6 months during 12 month post-enrollment
measure: Unmet needs
timeFrame: Baseline, every 3 months during 12 month post-enrollment
measure: Self-Reported Food Assistance Program Participation
timeFrame: Baseline, every 6 months during 12 month post-enrollment
measure: Change in Self-Reported Health Status
timeFrame: Baseline, monthly for 12-months post-enrollment
measure: Maternal attitudes and safe infant care practices
timeFrame: Baseline, every 6 months during 12 month post-enrollment
measure: Impact of COVID-19
timeFrame: Baseline, every 3 months during 12 month post-enrollment
measure: Program Experience
timeFrame: 6 months post-enrollment, 12 months post-enrollment
measure: Change in adult acute healthcare utilization
timeFrame: Baseline, every 6 months during 12 month post-enrollment
measure: Total adult patient-level cost of care
timeFrame: Baseline, every 6 months during 12 month post-enrollment
measure: Child healthcare utilization
timeFrame: Baseline, every 6 months during 12 month post-enrollment
measure: Child weight
timeFrame: Baseline, every 6 months during 12 month post-enrollment
measure: Child height
timeFrame: Baseline, every 6 months during 12 month post-enrollment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center Department of Pediatrics
name: Kelsey A Egan, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: