Health-Related Social Needs Food Boxes Delivery Program

NCT07643909 | Not Yet Recruiting

• 2 other identifiers: H-466084301831001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Food Insecurity

Keywords

Health-related social needs (HRSNs); Very low food security; Healthcare utilization; Food home delivery; Food access; Caregiver anxiety; Caregiver depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Caregiver depression

  Baseline, 6 months, 12 months

• Caregiver anxiety

  Baseline, 6 months, 12 months

• Quality of overall general health

  Baseline, 6 months, 12 months, monthly

• Quality of physical health

  Baseline, 6 months, 12 months, monthly

• Quality of mental health

  Baseline, 6 months, 12 months

Study Arms (2)

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.

Other: Standard of care

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.

Other: Monthly food staples and fresh produce

Interventions

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.

Standard of care control group

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.

Food home delivery intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• High-risk adolescent pregnancy
• Postpartum \<2 months

Sponsors & Collaborators

• Boston Medical Center: lead
• Wagner Foundation: collaborator

Study Sites (1)

Boston Medical Center, Pediatric Clinic

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ana Poblacion, PhD, MSc

  Boston Medical Center, Pediatrics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Poblacion, PhD, MSc

CONTACT

617-414-6366; Ana.Poblacion@bmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)