Food InsecurityNCT04652596
Reducing Food Insecurity During COVID-19
A study testing Produce prescription program and Grocery store gift cards in people with Food Insecurity, run by Boston Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Insecurity
- What is being tested?
- Produce prescription program and Grocery store gift cards
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2021to 13 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parent of a child 0-18 months of age
- Child receives care at Boston Medical Center
Who cannot join
- Planning to move residence outside of Boston within 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Food Insecurity
- Being tested
- Produce prescription program, Grocery store gift cards
- Keywords
- Produce prescription program, Mobile markets, Grocery store gift cards, Fruit and vegetable consumption, Low-income families, Social determinants of health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Produce prescription programOther
Also called Fresh Connect
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Grocery store gift cards |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, monthly for 12-months post-enrollment
Secondary outcomes (20)
Change in fruit & vegetable consumption
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.
Measured: Baseline, monthly for 12 months post-enrollment
Depression Symptoms
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.
Measured: Baseline, monthly for 12-months post-enrollment
Symptom Relief
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.
Measured: Baseline, monthly for 12-months post-enrollment
Changes of behavioral activation for depression
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.
Measured: Baseline, every 6 months during 12 month post-enrollment
Perceived Stress
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.
Measured: Baseline, every 6 months during 12 month post-enrollment
Social Support
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.
Measured: Baseline, every 6 months during 12 month post-enrollment
Medical outcomes social support
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.
Measured: Baseline, every 6 months during 12 month post-enrollment
Mastery Control
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.
Measured: Baseline, every 6 months during 12 month post-enrollment
Self-Esteem
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.
Measured: Baseline, every 6 months during 12 month post-enrollment
Unmet needs
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.
Measured: Baseline, every 3 months during 12 month post-enrollment
Self-Reported Food Assistance Program Participation
Self-reported participation in food assistance programs including Electronic Benefits Transfer (EBT), Food Stamps/Supplemental Nutrition Assistance Program (SNAP).
Measured: Baseline, every 6 months during 12 month post-enrollment
Change in Self-Reported Health Status
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.
Measured: Baseline, monthly for 12-months post-enrollment
Maternal attitudes and safe infant care practices
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.
Measured: Baseline, every 6 months during 12 month post-enrollment
Impact of COVID-19
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.
Measured: Baseline, every 3 months during 12 month post-enrollment
Program Experience
Assessed by 4-item USDA program experience questions. The questions ask about firm type use, dose of program usage, health education, and program satisfaction.
Measured: 6 months post-enrollment, 12 months post-enrollment
Change in adult acute healthcare utilization
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).
Measured: Baseline, every 6 months during 12 month post-enrollment
Total adult patient-level cost of care
Measured via claims data
Measured: Baseline, every 6 months during 12 month post-enrollment
Child healthcare utilization
EPIC chart abstractions (number of office visits, hospitalizations, missed appointments, immunization rates)
Measured: Baseline, every 6 months during 12 month post-enrollment
Child weight
EPIC chart abstractions (weight for age)
Measured: Baseline, every 6 months during 12 month post-enrollment
Child height
EPIC chart abstractions (height for age)
Measured: Baseline, every 6 months during 12 month post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start8 Feb 2021
- Primary completion13 Feb 2023
- Study completion13 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, United States Department of Agriculture (USDA), Krupp Family Foundation, Waldron Charitable Fund
- Responsible party
- Sponsor
- Investigators
- Kelsey A Egan, MD MSc, Principal investigator, Boston Medical Center Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652596
- Sponsor's protocol ID
- H-41052
- Other IDs
- 6007145, AD-1603-34662
- Status last verified
- Apr 2023
- First submitted
- 30 Nov 2020
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Two Interventions to Reduce Food Insecurity During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04652596
- Acronym / sponsor ID
- H-41052
- Conditions
- Food Insecurity
- Keywords
- Produce prescription program, Mobile markets, Grocery store gift cards, Fruit and vegetable consumption, Low-income families, Social determinants of health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, United States Department of Agriculture (USDA), Krupp Family Foundation, Waldron Charitable Fund
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 13 Feb 2023 (actual)
- Study completion
- 13 Feb 2023 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fresh Connect Produce Prescription Program | Active comparator | Other: Produce prescription programInvestigators 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. |
| Grocery store gift cards | Active comparator | Other: Grocery store gift cardsParticipants randomized to this comparator will receive grocery gift cards redeemable at conventional grocery stores. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Parent of a child 0-18 months of age
- Child receives care at Boston Medical Center
Key exclusion criteria (1 listed)
- Planning to move residence outside of Boston within 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Produce prescription programAlso: Fresh ConnectA 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 | Fresh Connect Produce Prescription Program |
| Grocery store gift cardsA monthly value of $150 in grocery store gift cards redeemable at conventional grocery stores will be provided to participants for 6 consecutive months. | Other | Grocery store gift cards |
Primary outcome
Change in Food Security
Time frame: Baseline, monthly for 12-months post-enrollment
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
20 secondary outcomes
Change in fruit & vegetable consumption
Time frame: Baseline, monthly for 12 months post-enrollment
Depression Symptoms
Time frame: Baseline, monthly for 12-months post-enrollment
Symptom Relief
Time frame: Baseline, monthly for 12-months post-enrollment
Changes of behavioral activation for depression
Time frame: Baseline, every 6 months during 12 month post-enrollment
Perceived Stress
Time frame: Baseline, every 6 months during 12 month post-enrollment
Social Support
Time frame: Baseline, every 6 months during 12 month post-enrollment
Medical outcomes social support
Time frame: Baseline, every 6 months during 12 month post-enrollment
Mastery Control
Time frame: Baseline, every 6 months during 12 month post-enrollment
Self-Esteem
Time frame: Baseline, every 6 months during 12 month post-enrollment
Unmet needs
Time frame: Baseline, every 3 months during 12 month post-enrollment
Self-Reported Food Assistance Program Participation
Time frame: Baseline, every 6 months during 12 month post-enrollment
Change in Self-Reported Health Status
Time frame: Baseline, monthly for 12-months post-enrollment
Maternal attitudes and safe infant care practices
Time frame: Baseline, every 6 months during 12 month post-enrollment
Impact of COVID-19
Time frame: Baseline, every 3 months during 12 month post-enrollment
Program Experience
Time frame: 6 months post-enrollment, 12 months post-enrollment
Change in adult acute healthcare utilization
Time frame: Baseline, every 6 months during 12 month post-enrollment
Total adult patient-level cost of care
Time frame: Baseline, every 6 months during 12 month post-enrollment
Child healthcare utilization
Time frame: Baseline, every 6 months during 12 month post-enrollment
Child weight
Time frame: Baseline, every 6 months during 12 month post-enrollment
Child height
Time frame: Baseline, every 6 months during 12 month post-enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelsey A Egan, MD MSc principal investigator
Boston Medical Center Department of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Produce prescription program and Grocery store gift cards in people with Food Insecurity, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Food Security (time frame: Baseline, monthly for 12-months post-enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023; AzTrials last refreshed its copy on 29 Oct 2026.