FreshStart for Health Study (FS4H)
8. september 2026 oppdatert av: Cornell University
FreshStart for Health: Produce Prescription to Promote Health Behaviors and Food Security.
The goal of this study is to test whether a produce prescription program (FS4H) influences health behaviors and food security.
FS4H engages a total of 4 cohorts to receive fresh local produce and nutrition lessons.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This project aims to evaluate the effectiveness and implementation of a produce prescription (PRx) program on health behaviors and food security.
The PRx program being evaluated, known as FreshStart for Health (FS4H), offers participants nutrition education lessons and access to fresh local produce (fruits and vegetables) across multiple cohorts, each with varying durations (8, 12, 18, or 24 weeks).
FS4H is administered by Buffalo Go Green, serving eligible Kaleida Health employees in Buffalo, New York.
Studietype
Intervensjonell
Registrering (Antatt)
200
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
New York
-
Buffalo, New York, Forente stater, 14209
- Kaledia Health
-
Buffalo, New York, Forente stater, 14211
- Buffalo Go Green
-
Buffalo, New York, Forente stater, 14215
- Nutrition Education: Holistic Wellness & Agricultural Education Campus, Buffalo Go Green
-
Buffalo, New York, Forente stater, 14222
- Nutrition Education (Teaching Kitchen Live/Recorded): Buffalo State University, Caudell Hall
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Age 18-65 years.
- Be enrolled in Kaleida's Highmark Blue Cross Blue Shield health plan.
- Having one of the following:
- Prediabetes.
- Diabetes.
- Prehypertension.
- Hypertension.
- Obesity.
- Food Insecurity.
- Financial insecurity.
Exclusion Criteria:
- Not being enrolled in Kaleida's Highmark Blue Cross Blue Shield health plan.
- Having no chronic health condition.
- Being food secure.
- Having financial stability.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Weekly produce prescriptions for eight (8) weeks.
At random (using a random number generator), participants will be assigned to join a cohort to receive produce prescription for 8, 12, 18, or 24 weeks.
Produce prescriptions can be picked up at a specified location or they can be delivered to participants' home.
Participants assigned under this arm will receive produce prescriptions up to 8 weeks total.
|
At random (using a random number generator), participants will be assigned to join a cohort to receive a weekly produce prescription for 8, 12, 18, or 24 weeks.
Produce prescriptions can be picked up at a specified location or they can be delivered to participants' home.
Participants will attend eight (8), one-hour nutrition education classes.
Nutrition education classes will be held primary in-person although a virtual (Zoom) option will be made available if necessary.
The classes will be recorded.
Nutrition education classes range in topics from eating healthy on a budget to cooking and recipe demonstrations, which entail attending a lecture portion that is combined with hands-on activities during each session.
|
|
Eksperimentell: Weekly produce prescriptions for twelve (12) weeks.
At random (using a random number generator), participants will be assigned to join a cohort to receive produce prescription for 8, 12, 18, or 24 weeks.
Produce prescriptions can be picked up at a specified location or they can be delivered to participants' home.
Participants assigned under this arm will receive produce prescriptions up to 12 weeks total.
|
At random (using a random number generator), participants will be assigned to join a cohort to receive a weekly produce prescription for 8, 12, 18, or 24 weeks.
Produce prescriptions can be picked up at a specified location or they can be delivered to participants' home.
Participants will attend eight (8), one-hour nutrition education classes.
Nutrition education classes will be held primary in-person although a virtual (Zoom) option will be made available if necessary.
The classes will be recorded.
Nutrition education classes range in topics from eating healthy on a budget to cooking and recipe demonstrations, which entail attending a lecture portion that is combined with hands-on activities during each session.
|
|
Eksperimentell: Weekly produce prescriptions for eighteen (18) weeks.
At random (using a random number generator), participants will be assigned to join a cohort to receive produce prescription for 8, 12, 18, or 24 weeks.
Produce prescriptions can be picked up at a specified location or they can be delivered to participants' home.
Participants assigned under this arm will receive produce prescriptions up to 18 weeks total.
|
At random (using a random number generator), participants will be assigned to join a cohort to receive a weekly produce prescription for 8, 12, 18, or 24 weeks.
Produce prescriptions can be picked up at a specified location or they can be delivered to participants' home.
Participants will attend eight (8), one-hour nutrition education classes.
Nutrition education classes will be held primary in-person although a virtual (Zoom) option will be made available if necessary.
The classes will be recorded.
Nutrition education classes range in topics from eating healthy on a budget to cooking and recipe demonstrations, which entail attending a lecture portion that is combined with hands-on activities during each session.
|
|
Eksperimentell: Weekly produce prescriptions for twenty-four (24) weeks.
At random (using a random number generator), participants will be assigned to join a cohort to receive produce prescription for 8, 12, 18, or 24 weeks.
Produce prescriptions can be picked up at a specified location or they can be delivered to participants' home.
Participants assigned under this arm will receive produce prescriptions up to 24 weeks total.
|
At random (using a random number generator), participants will be assigned to join a cohort to receive a weekly produce prescription for 8, 12, 18, or 24 weeks.
Produce prescriptions can be picked up at a specified location or they can be delivered to participants' home.
Participants will attend eight (8), one-hour nutrition education classes.
Nutrition education classes will be held primary in-person although a virtual (Zoom) option will be made available if necessary.
The classes will be recorded.
Nutrition education classes range in topics from eating healthy on a budget to cooking and recipe demonstrations, which entail attending a lecture portion that is combined with hands-on activities during each session.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Fruit and vegetable intake
Tidsramme: Up to 24 weeks.
|
Participants will complete the short form of the Dietary Screener Questionnaire (10 items) at baseline and post-intervention.
|
Up to 24 weeks.
|
|
Food security
Tidsramme: Up to 24 weeks.
|
Participants will complete the 6-item USDA Household Food Security Module to assess food security status at baseline and post-intervention.
|
Up to 24 weeks.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Physical and mental health outcomes
Tidsramme: Up to 24 weeks.
|
Participants will complete a set of validated scales at baseline and after completion of nutrition education classes.
|
Up to 24 weeks.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Roger Figueroa, Ph.D., M.P.H., M.Sc., Cornell University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
6. juli 2026
Primær fullføring (Antatt)
20. desember 2026
Studiet fullført (Antatt)
31. desember 2026
Datoer for studieregistrering
Først innsendt
13. januar 2026
Først innsendt som oppfylte QC-kriteriene
8. september 2026
Først lagt ut (Faktiske)
11. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. september 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB0149718
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .