Reducing Food Insecurity During COVID-19

Study Overview
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Brief Summary
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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.

Official Title
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Comparative Effectiveness of Two Interventions to Reduce Food Insecurity During the COVID-19 Pandemic

Conditions
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Food Insecurity

Intervention / Treatment
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* Other: Produce prescription program
* Other: Grocery store gift cards


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fresh Connect Produce Prescription Program<br>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<br>* 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.<br>* Other names: Fresh Connect;|
| Active Comparator: Grocery store gift cards<br>Participants randomized to this comparator will receive grocery gift cards redeemable at conventional grocery stores. | Other: Grocery store gift cards<br>* A monthly value of $150 in grocery store gift cards redeemable at conventional grocery stores will be provided to participants for 6 consecutive months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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). | Baseline, every 6 months during 12 month post-enrollment | 
| Total adult patient-level cost of care | Measured via claims data | Baseline, every 6 months during 12 month post-enrollment | 
| Child healthcare utilization | EPIC chart abstractions (number of office visits, hospitalizations, missed appointments, immunization rates) | Baseline, every 6 months during 12 month post-enrollment | 
| Child weight | EPIC chart abstractions (weight for age) | Baseline, every 6 months during 12 month post-enrollment | 
| Child height | EPIC chart abstractions (height for age) | Baseline, every 6 months during 12 month post-enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Produce prescription program, Mobile markets, Grocery store gift cards, Fruit and vegetable consumption, Low-income families, Social determinants of health