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Advancing North Shore Community Health Through Ocean-raised and faRm-grown Foods (ANCHOR Study) (ANCHOR)

16 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

50

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Massachusetts
      • Gloucester, Massachusetts, États-Unis, 01930
        • Tufts University (Investigator site) The Open Door (Recruitment & Intervention site)

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: 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.
Autres noms:
  • Medically supportive groceries
  • Food is Medicine
  • Meal kits

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Feasibility and Acceptability of Medically Supportive Meal Kit Program
Délai: 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)

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Food security
Délai: 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)
Nutrition Security
Délai: 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.
From enrollment to the end of the study (end of 12-weeks)
Cooking & Food Preparation Skills
Délai: 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.
From enrollment to the end of the study (end of 12-weeks)
Engagement in Nutrition Education
Délai: 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.
From enrollment to the end of the study (end of 12-weeks)
Diet quality
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Tufts University

Les enquêteurs

  • Chercheur principal: Kelseanna Hollis-Hansen, PhD, MPH, Tufts University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

2 juin 2026

Achèvement primaire (Estimé)

1 décembre 2026

Achèvement de l'étude (Estimé)

1 décembre 2026

Dates d'inscription aux études

Première soumission

8 juillet 2026

Première soumission répondant aux critères de contrôle qualité

8 juillet 2026

Première publication (Réel)

14 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

20 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

16 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • STUDY00006728

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

IPD including the study protocol, informed consent form, and clinical study report will be uploaded into the Tufts Dataverse library.

Délai de partage IPD

Within a year of study completion

Critères d'accès au partage IPD

Those who create an account and request access via Tufts Dataverse

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • CIF
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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