Health-Related Social Needs Food Boxes Delivery Program

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Level of Food insecurity in the past 12 months [Срок оценки: Baseline, 6 months, 12 months]

Вторичные конечные точки (8)

• Caregiver depression [Срок оценки: Baseline, 6 months, 12 months]
• Caregiver anxiety [Срок оценки: Baseline, 6 months, 12 months]
• Quality of overall general health [Срок оценки: Baseline, 6 months, 12 months, monthly]
• Quality of physical health [Срок оценки: Baseline, 6 months, 12 months, monthly]
• Quality of mental health [Срок оценки: Baseline, 6 months, 12 months]
• Quality of daily activities [Срок оценки: Baseline, 6 months, 12 months]
• Number of emergency room visits [Срок оценки: Baseline, 6 months, 12 months]
• Number of hospitalizations [Срок оценки: Baseline, 6 months, 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• High-risk adolescent pregnancy
• Postpartum <2 months

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Boston Medical Center, Pediatric Clinic — Boston

Идентификаторы

NCT: NCT07643909 · H-46608 · 4301831001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗