Food Insecurity
Conditions
Keywords
Produce prescription program, Mobile markets, Grocery store gift cards, Fruit and vegetable consumption, Low-income families, Social determinants of health
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.
Interventions
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.
OTHERGrocery store gift cards
A monthly value of $150 in grocery store gift cards redeemable at conventional grocery stores will be provided to participants for 6 consecutive months.
Sponsors
Patient-Centered Outcomes Research Institute
United States Department of Agriculture (USDA)
Krupp Family Foundation
Waldron Charitable Fund
Boston Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Food Security | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression Symptoms | Baseline, monthly for 12-months post-enrollment | 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. |
| Symptom Relief | Baseline, monthly for 12-months post-enrollment | 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. |
| Changes of behavioral activation for depression | Baseline, every 6 months during 12 month post-enrollment | 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. |
| Perceived Stress | Baseline, every 6 months during 12 month post-enrollment | 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. |
| Social Support | Baseline, every 6 months during 12 month post-enrollment | 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. |
| Medical outcomes social support | Baseline, every 6 months during 12 month post-enrollment | 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. |
| Mastery Control | Baseline, every 6 months during 12 month post-enrollment | 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. |
| Self-Esteem | Baseline, every 6 months during 12 month post-enrollment | 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. |
| Unmet needs | Baseline, every 3 months during 12 month post-enrollment | 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. |
| Change in fruit & vegetable consumption | Baseline, monthly for 12 months post-enrollment | 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. |
| Change in Self-Reported Health Status | Baseline, monthly for 12-months post-enrollment | 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. |
| Maternal attitudes and safe infant care practices | Baseline, every 6 months during 12 month post-enrollment | 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. |
| Impact of COVID-19 | Baseline, every 3 months during 12 month post-enrollment | 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. |
| Program Experience | 6 months post-enrollment, 12 months post-enrollment | Assessed by 4-item USDA program experience questions. The questions ask about firm type use, dose of program usage, health education, and program satisfaction. |
| Change in adult acute healthcare utilization | Baseline, every 6 months during 12 month post-enrollment | 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). |
| Total adult patient-level cost of care | Baseline, every 6 months during 12 month post-enrollment | Measured via claims data |
| Child healthcare utilization | Baseline, every 6 months during 12 month post-enrollment | EPIC chart abstractions (number of office visits, hospitalizations, missed appointments, immunization rates) |
| Child weight | Baseline, every 6 months during 12 month post-enrollment | EPIC chart abstractions (weight for age) |
| Child height | Baseline, every 6 months during 12 month post-enrollment | EPIC chart abstractions (height for age) |
| Self-Reported Food Assistance Program Participation | Baseline, every 6 months during 12 month post-enrollment | Self-reported participation in food assistance programs including Electronic Benefits Transfer (EBT), Food Stamps/Supplemental Nutrition Assistance Program (SNAP). |
Countries
United States
Outcome results
None listed