- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07703501
Advancing North Shore Community Health Through Ocean-raised and faRm-grown Foods (ANCHOR Study) (ANCHOR)
8. Juli 2026 aktualisiert von: Tufts University
This study is testing a new way to support healthy eating by providing free meal kits through a food pantry.
Adults who use The Open Door food pantry will receive meal kits that include fresh produce, seafood, and other ingredients, along with simple recipes and optional cooking demonstrations, over a 3-month period.
The goal is to learn whether these meal kits are helpful, easy to use, and a good fit for the community.
Researchers will also look at whether they help improve access to healthy foods, diet quality, and confidence with cooking.
Participants will be asked to complete short surveys at the beginning and end of the study, and some may be invited to join a group discussion to share their experiences.
Overall, the study aims to improve programs that connect people to healthy, locally sourced food and to inform future efforts to support nutrition and food access in the community.
Studienübersicht
Status
Rekrutierung
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Geschätzt)
50
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Kelseanna Hollis-Hansen, PhD, MPH
- Telefonnummer: 469-240-9112
- E-Mail: niche@tufts.edu
Studieren Sie die Kontaktsicherung
- Name: Adeline Peat, BS
- Telefonnummer: 469-240-9112
- E-Mail: niche@tufts.edu
Studienorte
-
-
Massachusetts
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Gloucester, Massachusetts, Vereinigte Staaten, 01930
- Rekrutierung
- Tufts University (Investigator site) The Open Door (Recruitment & Intervention site)
-
Kontakt:
- Kelseanna Hollis-Hansen, PhD, MPH
- Telefonnummer: (469) 240-9112
- E-Mail: niche@tufts.edu
-
-
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:
Participants must meet all of the following:
- Be 18 years of age or older
- Be a client of The Open Door food pantry in Gloucester, MA
- Be able to provide informed consent
Exclusion Criteria:
- Under age 18
- Unable to provide informed consent
- Have a food allergy, medical condition, or dietary restriction that makes it unsafe to eat the study foods (e.g., seafood or milk allergy, liquid diet)
- Another member of the same household is already participating (only one participant per household)
- Planning to move out of the area within the next 4 months
- Previously participated in a healthy meal kit program at The Open Door
- Do not have reliable transportation to pick up meal kits
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Medically supportive meal kits
Participants in this single-arm pilot study will receive a nutrition-focused meal kit intervention delivered through a community food pantry.
Over a 12-week period, participants will receive three meal kits per week during their regular pantry visits.
Each meal kit includes fresh produce, locally sourced seafood, and pantry staple ingredients (e.g., grains, seasonings), bundled together with simple, culturally relevant recipes designed to support preparation of healthy meals at home.
In addition to meal kit distribution, participants will be invited to attend optional onsite cooking demonstrations led by community partners, which provide hands-on guidance for preparing the recipes and using the provided ingredients.
Participants will also complete a baseline and follow-up survey, and a subset may be invited to participate in focus groups to share feedback on their experience with the program.
|
Participants in this single-arm pilot study will receive a nutrition-focused meal kit intervention delivered through a community food pantry.
Over a 12-week period, participants will receive three meal kits per week during their regular pantry visits.
Each meal kit includes fresh produce, locally sourced seafood, and pantry staple ingredients (e.g., grains, seasonings), bundled together with simple, culturally relevant recipes designed to support preparation of healthy meals at home.
In addition to meal kit distribution, participants will be invited to attend optional onsite cooking demonstrations led by community partners, which provide hands-on guidance for preparing the recipes and using the provided ingredients.
Participants will also complete a baseline and follow-up survey, and a subset may be invited to participate in focus groups to share feedback on their experience with the program.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Feasibility and Acceptability of Medically Supportive Meal Kit Program
Zeitfenster: From enrollment to the end of the study (end of 12-weeks)
|
The primary outcome assesses whether providing meal kits with locally sourced seafood and produce through a food pantry is practical and well-received.
This includes measures such as participation and retention rates, adherence to receiving meal kits, and participant feedback on satisfaction, ease of use, and cultural relevance of the meal kits and materials.
|
From enrollment to the end of the study (end of 12-weeks)
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Food security
Zeitfenster: From enrollment to the end of the study (end of 12-weeks)
|
Changes in participants' ability to reliably access enough food for an active, healthy life, measured using a standardized food security survey (USDA 6-item module).
|
From enrollment to the end of the study (end of 12-weeks)
|
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Nutrition Security
Zeitfenster: From enrollment to the end of the study (end of 12-weeks)
|
Changes in consistent access to foods that support health and prevent disease, assessed using a brief validated screening tool (Tufts Nutrition Security Screener) focused on access to nutritious foods.
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From enrollment to the end of the study (end of 12-weeks)
|
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Cooking & Food Preparation Skills
Zeitfenster: From enrollment to the end of the study (end of 12-weeks)
|
Changes in participants' confidence and ability to prepare meals at home, including using new ingredients and following recipes, assessed through validated cooking skills measures using Lavalle et al. 2017.
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From enrollment to the end of the study (end of 12-weeks)
|
|
Engagement in Nutrition Education
Zeitfenster: From enrollment to the end of the study (end of 12-weeks)
|
Participant exposure to and engagement with educational components, including attending cooking demonstrations and using recipes or educational materials provided with the meal kits.
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From enrollment to the end of the study (end of 12-weeks)
|
|
Diet quality
Zeitfenster: From enrollment to the end of the study (end of 12-weeks)
|
Changes in overall dietary patterns and alignment with healthy eating recommendations, measured using a validated diet quality instrument (e.g., MINI-EAT).
|
From enrollment to the end of the study (end of 12-weeks)
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Kelseanna Hollis-Hansen, PhD, MPH, Tufts 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)
2. Juni 2026
Primärer Abschluss (Geschätzt)
1. Dezember 2026
Studienabschluss (Geschätzt)
1. Dezember 2026
Studienanmeldedaten
Zuerst eingereicht
8. Juli 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
8. Juli 2026
Zuerst gepostet (Tatsächlich)
14. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
14. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
8. Juli 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- STUDY00006728
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
IPD including the study protocol, informed consent form, and clinical study report will be uploaded into the Tufts Dataverse library.
IPD-Sharing-Zeitrahmen
Within a year of study completion
IPD-Sharing-Zugriffskriterien
Those who create an account and request access via Tufts Dataverse
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- ICF
- CSR
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .