Health-Related Social Needs Food Boxes Delivery Program
ConditionFood Insecurity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
High-risk adolescent pregnancy
Postpartum <2 months
Trial design
Design model
Single group
Treatments tested in this trial
Monthly food staples and fresh produce
Other intervention1 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 care
Other interventionA 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Standard of care control groupActive comparator 1 intervention
Group B: Food home delivery intervention groupExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline, 6 months, 12 monthsSecondary outcomes
1
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.
Time frame
Baseline, 6 months, 12 months2
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.
Time frame
Baseline, 6 months, 12 months3
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".
Time frame
Baseline, 6 months, 12 months, monthly4
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.
Time frame
Baseline, 6 months, 12 months, monthlySponsors and contacts
Click on the lead sponsor to view all of their trials.
Boston Medical Center
Lead sponsor
Wagner Foundation
Collaborator
Source ClinicalTrials.gov
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