Fresh Takes!: An Evaluation of the Impact of Receiving Fresh Food Boxes

Part of paid clinical trials in The Bronx, New York.

Sponsor
Montefiore Medical Center
Study ID
NCT06019624
Status
Recruiting
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Conditions

  • Diabetes
  • Food Insecurity
  • PreDiabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Fresh Takes! — BEHAVIORAL
    Receipt of a fresh produce box, nutritional education and support in a 6 month program

Study Details

Fresh Takes! is a targeted food distribution and nutrition education program offered by Montefiore Bronx Health Collective, a Federally Qualified Health Center located in the South Bronx. The goal of Fresh Takes! is to help reduce food insecurity and prevent progressions to overt diabetes in patients with prediabetes and to help patients with overt diabetes achieve better diabetic control. To that end, participants receive bimonthly fresh food boxes and nutritional support and education over the course of a six-month program.

Key Dates

Start date
Sep 13, 2023
Status verified
Sep 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
400 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Cohort 1 Receipt of Food Box
    Up to 80 individuals with diabetes or prediabetes with a history of food insecurity enrolled in a 6 month program offering free bimonthly fresh food boxes, nutrition education, and individualized support. Each enrolled individual will serve as their own control. The study will evaluate pre and post program changes in reported self-obtained home glucose levels, food security, and dietary intake.
  • Active Comparator: Cohort 2 Receipt of Food Box
    Up to 80 individuals with diabetes or prediabetes with a history of food insecurity enrolled in a 6 month program offering free bimonthly fresh food boxes, nutrition education, and individualized support. Each enrolled individual will serve as their own control. The study will evaluate pre and post program changes in reported self-obtained home glucose levels, food security, and dietary intake.
  • Active Comparator: Cohort 3 Receipt of Food Box
    Up to 80 individuals with diabetes or prediabetes with a history of food insecurity enrolled in a 6 month program offering free bimonthly fresh food boxes, nutrition education, and individualized support. Each enrolled individual will serve as their own control. The study will evaluate pre and post program changes in reported self-obtained home glucose levels, food security, and dietary intake.
  • Active Comparator: Cohort 4 Receipt of Food Box
    Up to 80 individuals with diabetes or prediabetes with a history of food insecurity enrolled in a 6 month program offering free bimonthly fresh food boxes, nutrition education, and individualized support. Each enrolled individual will serve as their own control. The study will evaluate pre and post program changes in reported self-obtained home glucose levels, food security, and dietary intake.

Primary Outcome Measure

Change in HbA1c levels [ Time Frame: From baseline up to 12 months after program completion, up to 18 months total ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore Bronx Health CollectiveThe BronxNew York10459
Barbara Hackley, PHD
[email protected]
203-260-3599
Fadhylla [email protected], MPH
[email protected]
7189910605
Fadhylla Saballos, MPH (PRINCIPAL_INVESTIGATOR)
Rubayat Qadeer, MD (PRINCIPAL_INVESTIGATOR)
Barbara Hackley, PHD (SUB_INVESTIGATOR)

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By research site
Montefiore Bronx Health Collective· The Bronx, NY

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