- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04652596
Reducing Food Insecurity During COVID-19
April 25, 2023 updated by: Boston Medical Center
Comparative Effectiveness of Two Interventions to Reduce Food Insecurity During the COVID-19 Pandemic
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
250
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Fresh Connect Produce Prescription Program
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.
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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.
Other Names:
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Active Comparator: Grocery store gift cards
Participants randomized to this comparator will receive grocery gift cards redeemable at conventional grocery stores.
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A monthly value of $150 in grocery store gift cards redeemable at conventional grocery stores will be provided to participants for 6 consecutive months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Food Security
Time Frame: Baseline, monthly for 12-months post-enrollment
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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
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Baseline, monthly for 12-months post-enrollment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in fruit & vegetable consumption
Time Frame: Baseline, monthly for 12 months post-enrollment
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Self-reported consumption frequency of fruits, fruit juices, and vegetables in the past 30 days measured by 10-item Dietary Screener Questionnaire scale.
Each item is scored from "never" to "6 or more times per day".
Scoring algorithms convert frequency responses to cup equivalent estimates of average daily dietary intake for fruits and vegetables, using an age and gender coefficient.
The higher the score the more daily dietary intake for fruits and vegetables.
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Baseline, monthly for 12 months post-enrollment
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Depression Symptoms
Time Frame: Baseline, monthly for 12-months post-enrollment
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Assessed by the Quick Inventory of Depressive Symptoms (QIDS SR-16).
This scale is a 16-item self-report measure of depressive symptoms over the past 7 days.
Each item is scored 0-3 (0 = no presence of the symptom; 3 = high burden of the symptom), yielding a total score range of 0 to 27.
Because of its wide scoring range, the QIDS can be used to detect depressive illness in populations with low symptoms.
Lower scores reflect less depressive symptoms.
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Baseline, monthly for 12-months post-enrollment
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Symptom Relief
Time Frame: Baseline, monthly for 12-months post-enrollment
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Assessed by the Beck Anxiety Inventory (BAI).
This scale is a 21-item self-report measure the severity of self-reported anxiety.
Each item is scored 0-3 (0 = not at all; 3 = severely - it bothered me a lot), yielding a total score range of 0 to 63.
The lower the score the less self-reported anxiety.
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Baseline, monthly for 12-months post-enrollment
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Changes of behavioral activation for depression
Time Frame: Baseline, every 6 months during 12 month post-enrollment
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Assessed by the Behavioral Activation for Depression Scale (BADS).
This 25-item self-reported measure is used to track changes weekly in the behaviors hypothesized to underlie depression and specifically targeted for change by behavioral activation.
The BADS subscales include activation, avoidance/rumination, work/school impairment, and social impairment.
Each item is scored 0-6 (0=not at all; 6=completely), yielding a total score range of 0 to 150.
High scores indicate greater levels of activation.
For all the subscores, high scores are consistent with the subscale name.
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Baseline, every 6 months during 12 month post-enrollment
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Perceived Stress
Time Frame: Baseline, every 6 months during 12 month post-enrollment
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Assessed by Perceived Stress Scale (PSS).
This 14-item psychological instrument measures the perception of stress and the degree to which situations in one's life are appraised as stressful.
Each item is scored 0-4 (0=never; 4= very often).
The scores is obtained by first reversing the scores on items 4, 5, 6, 7, 9, 10, and 13 and then summing the reverse coded items with the rest of the items.
The scores can range from 0 to 40 with higher scores indicating higher perceived stress.
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Baseline, every 6 months during 12 month post-enrollment
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Social Support
Time Frame: Baseline, every 6 months during 12 month post-enrollment
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Assessed by Social Adjustment Scale Self-Report (SAS-SR).
This 54-item measure examines social and role functioning in six areas: work; social activities; relationships with family; spouse or partner; parent; member of family unit.
Items are rated on a 5-point scale.
Seven mean scores are generated, six-role areas and one overall means.
The mean scores are converted into standard T-scores on the SAS-SR Profile Form.
Higher scores indicate greater impairment of functioning.
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Baseline, every 6 months during 12 month post-enrollment
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Medical outcomes social support
Time Frame: Baseline, every 6 months during 12 month post-enrollment
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Assessed by Medical Outcomes Survey Social Support (MOSSS).
This 18-item tool comprises 4 functional support scales (emotional/informational, tangible, affectionate, and positive interaction) and an overall social support index.
Each item is scored 0-5 (0=none of the time; 5=all of the time).
The higher the overall social support index the more support.
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Baseline, every 6 months during 12 month post-enrollment
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Mastery Control
Time Frame: Baseline, every 6 months during 12 month post-enrollment
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Assessed by Pearlin Mastery Scale (PMS).
This 7-item tool measures the extent to which an individual regards their life chances as being under their personal control rather than fatalistically ruled.
Each item is scored 1-4 (1=strongly agree; 4=strongly disagree) and the values are added.
The scores can range from 7 to 28 with higher scores reflect greater mastery.
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Baseline, every 6 months during 12 month post-enrollment
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Self-Esteem
Time Frame: Baseline, every 6 months during 12 month post-enrollment
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Assessed by Rosenberg's Self-Esteem Scale (RSES).
This 10-item self-report likert scale evaluates an individual's self-esteem.
Each item is scored from strong agree to strongly disagree.
The higher the sum of the scores, the higher the self-esteem.
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Baseline, every 6 months during 12 month post-enrollment
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Unmet needs
Time Frame: Baseline, every 3 months during 12 month post-enrollment
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Assessed by WE CARE.
This 12-question screening tool assesses needs in 6 domains: parental educational attainment, employment, child care, risk of homelessness, food security, and household heat and electricity.
Individuals respond with "Yes", "No", or "Maybe later".
Those with unmet needs are provided with a locally developed community resource information sheet.
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Baseline, every 3 months during 12 month post-enrollment
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Self-Reported Food Assistance Program Participation
Time Frame: Baseline, every 6 months during 12 month post-enrollment
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Self-reported participation in food assistance programs including Electronic Benefits Transfer (EBT), Food Stamps/Supplemental Nutrition Assistance Program (SNAP).
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Baseline, every 6 months during 12 month post-enrollment
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Change in Self-Reported Health Status
Time Frame: Baseline, monthly for 12-months post-enrollment
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Self-reported health status measured by a report of health status as excellent, very good, good, fair, or poor and measured by 3-item CDC Healthy Days module for a disarticulation of physical and mental health.
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Baseline, monthly for 12-months post-enrollment
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Maternal attitudes and safe infant care practices
Time Frame: Baseline, every 6 months during 12 month post-enrollment
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Assessed by the Pregnancy Risk Assessment Monitoring System (PRAMS).
The survey Identifies groups of women and infants at high risk for health problems, monitors changes in health status, and measures progress towards goals in improving the health of mothers and infants.
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Baseline, every 6 months during 12 month post-enrollment
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Impact of COVID-19
Time Frame: Baseline, every 3 months during 12 month post-enrollment
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The Epidemic - Pandemic Impacts Inventory (EPII) + 4-item self-report of the impact of the pandemic on financial capacity and food purchasing/acquisition patterns.
The EPII is newly developed, thus, scoring procedures will be determined by future research.
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Baseline, every 3 months during 12 month post-enrollment
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Program Experience
Time Frame: 6 months post-enrollment, 12 months post-enrollment
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Assessed by 4-item USDA program experience questions.
The questions ask about firm type use, dose of program usage, health education, and program satisfaction.
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6 months post-enrollment, 12 months post-enrollment
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Change in adult acute healthcare utilization
Time Frame: Baseline, every 6 months during 12 month post-enrollment
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Claims data composite measure (all cause hospital admissions and ED visits; Total number of all-cause ED visits; Total number of all-cause discharges from IP).
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Baseline, every 6 months during 12 month post-enrollment
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Total adult patient-level cost of care
Time Frame: Baseline, every 6 months during 12 month post-enrollment
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Measured via claims data
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Baseline, every 6 months during 12 month post-enrollment
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Child healthcare utilization
Time Frame: Baseline, every 6 months during 12 month post-enrollment
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EPIC chart abstractions (number of office visits, hospitalizations, missed appointments, immunization rates)
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Baseline, every 6 months during 12 month post-enrollment
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Child weight
Time Frame: Baseline, every 6 months during 12 month post-enrollment
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EPIC chart abstractions (weight for age)
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Baseline, every 6 months during 12 month post-enrollment
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Child height
Time Frame: Baseline, every 6 months during 12 month post-enrollment
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EPIC chart abstractions (height for age)
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Baseline, every 6 months during 12 month post-enrollment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kelsey A Egan, MD MSc, Boston Medical Center Department of Pediatrics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 8, 2021
Primary Completion (Actual)
February 13, 2023
Study Completion (Actual)
February 13, 2023
Study Registration Dates
First Submitted
November 30, 2020
First Submitted That Met QC Criteria
December 2, 2020
First Posted (Actual)
December 3, 2020
Study Record Updates
Last Update Posted (Actual)
April 27, 2023
Last Update Submitted That Met QC Criteria
April 25, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H-41052
- AD-1603-34662 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute (PCORI))
- 6007145 (Other Grant/Funding Number: United States Department of Agriculture (USDA))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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