NCT07703501

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
Jun 2026Dec 2026

Study Start

First participant enrolled

June 2, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

July 8, 2026

Last Update Submit

July 16, 2026

Conditions

Keywords

Food is MedicineMedically supportive groceriesLocal foodDASH diet

Outcome Measures

Primary Outcomes (1)

  • Feasibility and Acceptability of Medically Supportive Meal Kit Program

    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)

Other Outcomes (5)

  • Food security

    From enrollment to the end of the study (end of 12-weeks)

  • Nutrition Security

    From enrollment to the end of the study (end of 12-weeks)

  • Cooking & Food Preparation Skills

    From enrollment to the end of the study (end of 12-weeks)

  • +2 more other outcomes

Study Arms (1)

Medically supportive meal kits

EXPERIMENTAL

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.

Behavioral: Medically supportive meal kits

Interventions

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.

Also known as: Medically supportive groceries, Food is Medicine, Meal kits
Medically supportive meal kits

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts University (Investigator site) The Open Door (Recruitment & Intervention site)

Gloucester, Massachusetts, 01930, United States

Location

Study Officials

  • Kelseanna Hollis-Hansen, PhD, MPH

    Tufts University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2026

First Posted

July 14, 2026

Study Start

June 2, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 20, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
Within a year of study completion
Access Criteria
Those who create an account and request access via Tufts Dataverse
More information

Locations