Food InsecurityHRSNNCT07643909
Health-Related Social Needs Food Boxes Delivery Program
A study testing Monthly food staples and fresh produce in people with Food Insecurity, run by Boston Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Food Insecurity
- What is being tested?
- Monthly food staples and fresh produce
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- High-risk adolescent pregnancy
- Postpartum <2 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Boston Medical Center, Pediatric Clinic
Boston, Massachusetts, 02118
Ana Poblacion, PhD, MSc, Ana.Poblacion@bmc.org
About this study
Official title: 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.
Read the detailed description
Pediatric families will be enrolled in a 2-step process:
- 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;
- 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.
- Conditions
- Food Insecurity
- Being tested
- Monthly food staples and fresh produce, Standard of care
- Keywords
- Health-related social needs (HRSNs), Very low food security, Healthcare utilization, Food home delivery, Food access, Caregiver anxiety, Caregiver depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monthly food staples and fresh produceOther
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.
Standard of careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Monthly food staples and fresh produce |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 months, 12 months
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study startJan 2027 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Wagner Foundation
- Responsible party
- Sponsor
- Investigators
- Ana Poblacion, PhD, MSc, Principal investigator, Boston Medical Center, Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643909
- Sponsor's protocol ID
- H-46608
- Other IDs
- 4301831001
- Acronym
- HRSN
- Status last verified
- Oct 2026
- First submitted
- 8 Jun 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nourishing At Home: Health-Related Social Needs Food Boxes Delivery Program
- ClinicalTrials.gov ID
- NCT07643909
- Acronym / sponsor ID
- HRSN / H-46608
- Conditions
- Food Insecurity
- Keywords
- Health-related social needs (HRSNs), Very low food security, Healthcare utilization, Food home delivery, Food access, Caregiver anxiety, Caregiver depression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Wagner Foundation
- Study start
- Jan 2027 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pediatric families will be enrolled in a 2-step process:
- 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;
- 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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard of care control group | Active comparator | Other: Standard of careAll participants will initially be assigned to this group for 6 months and will receive standard of care. |
| Food home delivery intervention group | Experimental | Other: Monthly food staples and fresh produceAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- High-risk adolescent pregnancy
- Postpartum <2 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monthly food staples and fresh produce1 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. | Other | Food home delivery intervention group |
| Standard of careA 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. | Other | Standard of care control group |
Primary outcome
Level of Food insecurity in the past 12 months
Time frame: Baseline, 6 months, 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.
8 secondary outcomes
Caregiver depression
Time frame: Baseline, 6 months, 12 months
Caregiver anxiety
Time frame: Baseline, 6 months, 12 months
Quality of overall general health
Time frame: Baseline, 6 months, 12 months, monthly
Quality of physical health
Time frame: Baseline, 6 months, 12 months, monthly
Quality of mental health
Time frame: Baseline, 6 months, 12 months
Quality of daily activities
Time frame: Baseline, 6 months, 12 months
Number of emergency room visits
Time frame: Baseline, 6 months, 12 months
Number of hospitalizations
Time frame: Baseline, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ana Poblacion, PhD, MSc principal investigator
Boston Medical Center, Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monthly food staples and fresh produce in people with Food Insecurity, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Poblacion, PhD, MSc (617-414-6366, Ana.Poblacion@bmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Food insecurity in the past 12 months (time frame: Baseline, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.