- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07703501
Advancing North Shore Community Health Through Ocean-raised and faRm-grown Foods (ANCHOR Study) (ANCHOR)
8. juli 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
50
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Kelseanna Hollis-Hansen, PhD, MPH
- Telefonnummer: 469-240-9112
- E-mail: niche@tufts.edu
Undersøgelse Kontakt Backup
- Navn: Adeline Peat, BS
- Telefonnummer: 469-240-9112
- E-mail: niche@tufts.edu
Studiesteder
-
-
Massachusetts
-
Gloucester, Massachusetts, Forenede Stater, 01930
- Rekruttering
- 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
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde 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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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 navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility and Acceptability of Medically Supportive Meal Kit Program
Tidsramme: 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)
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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).
|
From enrollment to the end of the study (end of 12-weeks)
|
|
Nutrition Security
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Kelseanna Hollis-Hansen, PhD, MPH, Tufts University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
2. juni 2026
Primær færdiggørelse (Anslået)
1. december 2026
Studieafslutning (Anslået)
1. december 2026
Datoer for studieregistrering
Først indsendt
8. juli 2026
Først indsendt, der opfyldte QC-kriterier
8. juli 2026
Først opslået (Faktiske)
14. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- STUDY00006728
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (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
IPD-delingsadgangskriterier
Those who create an account and request access via Tufts Dataverse
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- ICF
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Kostkvalitet
-
NorthShore University HealthSystemUkendt
-
Ankara Yildirim Beyazıt UniversityIkke rekrutterer endnuOrtopædkirurgi | Komfort | Sygepleje | Quality of Recovery 40
-
University Hospital, Clermont-FerrandAfsluttetOral Health Related Quality of Life (OHRQoL)Frankrig
-
Tanta UniversityIkke rekrutterer endnuModificeret radikal mastektomi | Quality of Recovery (QoR-15)Egypten
-
Chinese University of Hong KongIkke rekrutterer endnuHepatektomi | Intertransversal procesblok | Quality of Recovery (QoR-15)
-
Marlene FischerAfsluttetPostoperativ Quality of Recovery på postanæstesiafdelingenTyskland
-
University Hospital, GrenobleUkendtHealth Care Quality Management (ingen betingelse).Frankrig
-
Ondokuz Mayıs UniversityAfsluttetKejsersnit | Intratekal morfin | Quality of Recovery 40Kalkun
-
Anqing Municipal HospitalAfsluttetDexmedetomidin | Lidokain | Quality of Recovery (QoR-40), præoperativ og postoperativKina
-
Cairo UniversityRekrutteringQuality of Recovery (QoR-15) | Sadelblok-anæstesi | Klart til udskrivelseEgypten