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| ID | Type | Description | Link |
|---|---|---|---|
| 4301831001 | Other Grant/Funding Number | Wagner Foundation |
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| Name | Class |
|---|---|
| Wagner Foundation | UNKNOWN |
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Nourishing At Home: Health-Related Social Needs Food Boxes Delivery Program is a pilot intervention study evaluating whether home delivery of medically tailored food boxes can reduce food insecurity and improve health outcomes among pediatric families including caregiver physical and mental health, child physical health, and overall family well-being.
Pediatric families will be enrolled in a 2-step process:
Eligible families living within a 20-mile radius of BMC and with a safe delivery location will first receive standard of care for six months then they will be assigned to receive one home-delivered food box per month for six months containing staple foods and fresh produce, in a stepped wedge design.
The study will examine whether home food delivery reduces food insecurity severity and improves caregiver physical and mental health, child physical health, and overall family well-being. Outcomes expected include food security status change, decrease in caregiver anxiety and depression positive screens, increase in quality of life as well as decrease adult and child healthcare utilization. By addressing both financial and physical barriers to food access, this research will evaluate whether healthcare-based nutrition interventions can meaningfully improve health and social outcomes for food-insecure pediatric families while potentially reducing avoidable healthcare utilization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care control group | Active Comparator | All participants will initially be assigned to this group for 6 months and will receive standard of care. |
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| Food home delivery intervention group | Experimental | After the 6 months of standard of care all participants assigned to this group will receive in their homes one box of food per month for six months, containing food staples and fresh produce. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monthly food staples and fresh produce | Other | 1 bag of rice, 1 bag of dried beans, 1 can of beans, 1 box of pasta, 1 can of pasta sauce, 2 cans of soup, 2 cans of vegetables, 1 box of cereal, 1 box of milk, 2 cans of tuna, fresh fruits and vegetables. |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Food insecurity in the past 12 months | Food insecurity will be measured using the 18-item Household Food Security Survey Module (HFSSM) with a 12-month recall period, which classifies the households as high, low, or very low food security. It also classifies children's experiences with food insecurity. And again, in monthly surveys with a recall period of 30 days. | Baseline, 6 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver depression | Depression will be assessed with The Patient Health Questionnaire-2 (PHQ2). It is a 2 item instrument with a 2-week recall period and potential responses from 0 to 3 for each item, where 0= not at all, and 3= nearly every day. PHQ-2 scores range from 0 to 6, and a positive depression screen is a score of 3 or higher. | Baseline, 6 months, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana Poblacion, PhD, MSc | Contact | 617-414-6366 | Ana.Poblacion@bmc.org |
| Name | Affiliation | Role |
|---|---|---|
| Ana Poblacion, PhD, MSc | Boston Medical Center, Pediatrics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center, Pediatric Clinic | Boston | Massachusetts | 02118 | United States |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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A stepped wedge design will be done where participants will initially receive standard of care (control) for six months and then receive the home delivery food boxes (intervention) for six months.
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| Standard of care | Other | A referral to the Boston Medical Center Food Pantry, where patients can collect food bags for themselves and their families twice a month. Pediatric families will also receive a food resource guide. |
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| Caregiver anxiety | Anxiety will be assessed using the Generalized Anxiety Disorder two-item (GAD-2) scale for anxiety. It is a 2 item instrument with a 2-week recall period and potential responses from 0 to 3 for each item, where 0= not at all, and 3= nearly every day. GAD-2 scores range from 0 to 6, and a positive anxiety screen is a score of 3 or higher. | Baseline, 6 months, 12 months |
| Quality of overall general health | Quality of general health will be assessed using responses from the first question of the 4-question Population Health-Related Quality of Life (HRQOL-4) which is designed to assess self-perceived recent health over the past 30 days. four key domains-general health, physical health, mental health, and activity limitations. The potential responses of (Excellent, Very Good, Good, Fair, Poor) will be dichotomized into two categories of "excellent/very good/good" and "fair/poor". | Baseline, 6 months, 12 months, monthly |
| Quality of physical health | Quality of physical health will be assessed using responses from the second question of the 4-question Population Health-Related Quality of Life (HRQOL-4). Thinking about your physical health, which includes physical illness and injury, how many days during the past 30 days was your physical health not good? Responses will be dichotomized into 14 days or more and 13 days or less. The category of 14 days or more suggests that they are having frequent physical distress. | Baseline, 6 months, 12 months, monthly |
| Quality of mental health | Quality of mental health will be assessed using responses from the third question of the 4-question Population Health-Related Quality of Life (HRQOL-4). Thinking about your mental health, which includes stress, depression, and problems with emotions, how many days during the past 30 days was your mental health not good? Responses will be dichotomized into 14 days or more and 13 days or less. The category of 14 days or more suggests that they are having frequent mental distress. | Baseline, 6 months, 12 months |
| Quality of daily activities | Quality of daily activities will be assessed using responses from the third question of the 4-question Population Health-Related Quality of Life (HRQOL-4). During the past 30 days, approximately how many days did poor physical or mental health keep you from doing your usual activities, such as self-care, work, or recreation? Responses will be dichotomized into 14 days or more and 13 days or less. The category of 14 days or more suggests that they are having frequent activity limitations. | Baseline, 6 months, 12 months |
| Number of emergency room visits | Emergency room visits will be measured by asking participants, 'How many times was the adult/child a patient in the emergency room during the past 12 months?' And again, in monthly surveys with a recall period of 30 days. | Baseline, 6 months, 12 months |
| Number of hospitalizations | Hospitalizations will be measured by asking participants 'How many different times did this adult/child stay in a hospital overnight or longer during the past 12 months? (Do not count total number of nights, just total number of hospital admissions for stays which lasted 1 or more nights. Do not count emergency room visits or hospitalizations for childbirth.)' And again, in monthly surveys with a recall period of 30 days. | Baseline, 6 months, 12 months |