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

10. června 2026 aktualizováno: Boston Medical Center

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

50

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Spojené státy
    • Massachusetts
      • Boston, Massachusetts, Spojené státy, 02118

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Výzkum zdravotnických služeb
  • Přidělení: Nerandomizované
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Standard of care control group
All participants will initially be assigned to this group for 6 months and will receive standard of care.
Jiný: 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.
Experimentální: 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.
Jiný: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Level of Food insecurity in the past 12 months
Časové okno: 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.
Baseline, 6 months, 12 months

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Caregiver depression
Časové okno: Baseline, 6 months, 12 months
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
Časové okno: Baseline, 6 months, 12 months
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
Časové okno: Baseline, 6 months, 12 months, monthly
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
Časové okno: Baseline, 6 months, 12 months, monthly
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
Časové okno: Baseline, 6 months, 12 months
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
Časové okno: Baseline, 6 months, 12 months
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
Časové okno: Baseline, 6 months, 12 months
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
Časové okno: Baseline, 6 months, 12 months
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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Boston Medical Center

Spolupracovníci

Wagner Foundation

Vyšetřovatelé

  • Vrchní vyšetřovatel: Ana Poblacion, PhD, MSc, Boston Medical Center, Pediatrics

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. srpna 2026

Primární dokončení (Odhadovaný)

1. září 2028

Dokončení studie (Odhadovaný)

1. září 2028

Termíny zápisu do studia

První předloženo

8. června 2026

První předloženo, které splnilo kritéria kontroly kvality

10. června 2026

První zveřejněno (Aktuální)

12. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

12. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

10. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • H-46608
  • 4301831001 (Jiné číslo grantu/financování: Wagner Foundation)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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