- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07703501
Advancing North Shore Community Health Through Ocean-raised and faRm-grown Foods (ANCHOR Study) (ANCHOR)
16. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
50
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Massachusetts
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Gloucester, Massachusetts, Forente stater, 01930
- Tufts University (Investigator site) The Open Door (Recruitment & Intervention site)
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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:
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
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: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Feasibility and Acceptability of Medically Supportive Meal Kit Program
Tidsramme: From enrollment to the end of the study (end of 12-weeks)
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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.
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From enrollment to the end of the study (end of 12-weeks)
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Food security
Tidsramme: 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).
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From enrollment to the end of the study (end of 12-weeks)
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Nutrition Security
Tidsramme: From enrollment to the end of the study (end of 12-weeks)
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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
Tidsramme: From enrollment to the end of the study (end of 12-weeks)
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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)
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Engagement in Nutrition Education
Tidsramme: From enrollment to the end of the study (end of 12-weeks)
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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)
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Diet quality
Tidsramme: From enrollment to the end of the study (end of 12-weeks)
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Changes in overall dietary patterns and alignment with healthy eating recommendations, measured using a validated diet quality instrument (e.g., MINI-EAT).
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From enrollment to the end of the study (end of 12-weeks)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Kelseanna Hollis-Hansen, PhD, MPH, Tufts 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)
2. juni 2026
Primær fullføring (Antatt)
1. desember 2026
Studiet fullført (Antatt)
1. desember 2026
Datoer for studieregistrering
Først innsendt
8. juli 2026
Først innsendt som oppfylte QC-kriteriene
8. juli 2026
Først lagt ut (Faktiske)
14. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- STUDY00006728
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
IPD including the study protocol, informed consent form, and clinical study report will be uploaded into the Tufts Dataverse library.
IPD-delingstidsramme
Within a year of study completion
Tilgangskriterier for IPD-deling
Those who create an account and request access via Tufts Dataverse
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- ICF
- CSR
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. .