FreshStart for Health Study (FS4H)
8. September 2026 aktualisiert von: 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.
Studienübersicht
Status
Aktiv, nicht rekrutierend
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
200
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
New York
-
Buffalo, New York, Vereinigte Staaten, 14209
- Kaledia Health
-
Buffalo, New York, Vereinigte Staaten, 14211
- Buffalo Go Green
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Buffalo, New York, Vereinigte Staaten, 14215
- Nutrition Education: Holistic Wellness & Agricultural Education Campus, Buffalo Go Green
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Buffalo, New York, Vereinigte Staaten, 14222
- Nutrition Education (Teaching Kitchen Live/Recorded): Buffalo State University, Caudell Hall
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Sequenzielle Zuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Fruit and vegetable intake
Zeitfenster: 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
Zeitfenster: 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.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Physical and mental health outcomes
Zeitfenster: 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.
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Roger Figueroa, Ph.D., M.P.H., M.Sc., Cornell University
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
6. Juli 2026
Primärer Abschluss (Geschätzt)
20. Dezember 2026
Studienabschluss (Geschätzt)
31. Dezember 2026
Studienanmeldedaten
Zuerst eingereicht
13. Januar 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
8. September 2026
Zuerst gepostet (Tatsächlich)
11. September 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
11. September 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
8. September 2026
Zuletzt verifiziert
1. April 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IRB0149718
Plan für individuelle Teilnehmerdaten (IPD)
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NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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