Health-Related Social Needs Food Boxes Delivery Program (HRSN)

Nourishing At Home: Health-Related Social Needs Food Boxes Delivery Program

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Food Insecurity
• Intervention / Treatment: Other: Standard of care; Other: Monthly food staples and fresh produce

Detailed Description

Pediatric families will be enrolled in a 2-step process:

1. Families must screen positive for food insecurity risk using the Hunger Vital Sign™ (HVS) during routine clinical visits at Boston Medical Center (BMC) as well as have a child with at least one health-need criteria;
2. Families must screen positive for very low food insecurity risk using the 1-Item Very Low Food Security (VLFS) screen.

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ana Poblacion, PhD, MSc; Phone Number: 617-414-6366; Email: Ana.Poblacion@bmc.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center, Pediatric Clinic
      • Contact: Ana Poblacion, PhD, MSc; Email: Ana.Poblacion@bmc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant has a child younger than 18 years seen by the Boston Medical Center Pediatrics Department and the child has a qualifying Health condition [listed below]
• Screens positive for food insecurity risk (Hunger Vital Sign + 1-Item VLFS) and/or has received food support (billing code on the electronic health record for food need using a positive response to the THRIVE question "Do you need support with food? [apply for Supplemental Nutrition Assistance Program (SNAP), Women, Infants and Children (WIC), referral to food pantry]" (ICD-10 Z-59.48)), and/or has received a food insecurity resource guide and/or has received food emergency (referral to the BMC food pantry within seven days of encounter).
• Child of participant has a health-related condition such as: a behavioral health need (anxiety, Attention-Deficit/Hyperactivity Disorder (ADHD), depression, serious emotional disturbance, serious mental illness, substance use disorder, trauma/stress disorder), complex physical health condition (autoimmune conditions, developmental disabilities, GI conditions, hematological conditions, metabolic conditions, and neurologic conditions), needs assistance with self-care tasks or more complex tasks, has repeated Emergency Department (ED) use (2 or more times in past 6 months or 4 or more times in the past 12 months).
• Participant speaks English and/or Spanish

Exclusion Criteria:

• High-risk adolescent pregnancy
• Postpartum <2 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of care control group; All participants will initially be assigned to this group for 6 months and will receive standard of care.	Other: Standard of care; 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.
Experimental: Food home delivery intervention group; 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.	Other: Monthly food staples and fresh produce; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: Wagner Foundation
• Investigators: Principal Investigator: Ana Poblacion, PhD, MSc, Boston Medical Center, Pediatrics

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: June 8, 2026
• First Submitted That Met QC Criteria: June 10, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Food access; Healthcare utilization; Caregiver anxiety; Health-related social needs (HRSNs); Very low food security; Food home delivery; Caregiver depression
• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: H-46608; 4301831001 (Other Grant/Funding Number: Wagner Foundation)

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