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

10 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

50

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02118

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Standard of care control group
All participants will initially be assigned to this group for 6 months and will receive standard of care.
Altro: 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.
Sperimentale: 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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Level of Food insecurity in the past 12 months
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Caregiver depression
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Boston Medical Center

Collaboratori

Wagner Foundation

Investigatori

  • Investigatore principale: Ana Poblacion, PhD, MSc, Boston Medical Center, Pediatrics

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

1 settembre 2028

Completamento dello studio (Stimato)

1 settembre 2028

Date di iscrizione allo studio

Primo inviato

8 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

10 giugno 2026

Primo Inserito (Effettivo)

12 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • H-46608
  • 4301831001 (Altro numero di sovvenzione/finanziamento: Wagner Foundation)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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