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Behavioral Intervention
Fresh Food Boxes for Food Insecurity
N/A
Recruiting
Led By Rubayat Qadeer, MD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18-75 years of age
Identified as having diabetes based on an ICD diagnosis code in the Electronic Medical Record (EMR) or having a less than ideal HbA1c level, defined as >6.4% within the preceding 12 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months after program completion, up to 18 months total
Awards & highlights
Study Summary
This trial helps reduce food insecurity in the South Bronx by providing fresh food boxes & nutritional support & education over 6 months.
Who is the study for?
This trial is for adults aged 18-75 who are patients at BHC, have experienced food insecurity in the past year, and have been identified with prediabetes or diabetes through specific diagnostic codes or HbA1c levels.Check my eligibility
What is being tested?
The 'Fresh Takes!' program provides participants with fresh food boxes every two weeks and nutritional education to help those with prediabetes avoid developing diabetes and assist diabetic individuals in better managing their condition over six months.See study design
What are the potential side effects?
Since this intervention involves healthy food distribution and nutrition education rather than medication, no traditional side effects are expected. However, dietary changes may affect individual health conditions differently.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
Select...
I have diabetes or my HbA1c level was over 6.4% in the last year.
Select...
I have been diagnosed with prediabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline up to 12 months after program completion, up to 18 months total
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to 12 months after program completion, up to 18 months total
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Food Security
Change in HbA1c levels
Secondary outcome measures
Change in Emergency Room Utilization
Change in Fruit and Vegetable Intake
Number of diabetes-related primary health care visits
Trial Design
4Treatment groups
Active Control
Group I: Cohort 4 Receipt of Food BoxActive Control1 Intervention
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.
Group II: Cohort 1 Receipt of Food BoxActive Control1 Intervention
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.
Group III: Cohort 2 Receipt of Food BoxActive Control1 Intervention
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.
Group IV: Cohort 3 Receipt of Food BoxActive Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
444 Previous Clinical Trials
582,160 Total Patients Enrolled
United States Department of Agriculture (USDA)FED
97 Previous Clinical Trials
350,362 Total Patients Enrolled
Barbara Hackley, PhDStudy DirectorMontefiore Medical Center
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the research project in question open to people aged fifty and above?
"This trial is seeking out adults aged between 18 and 75 to participate."
Answered by AI
What qualities should a participant possess to be eligible for this experiment?
"In order to take part in this study, individuals must have been diagnosed with pre-diabetes and be between the ages of 18 - 75. This trial is currently recruiting 400 participants."
Answered by AI
Are there any opportunities to volunteer for this medical experiment at the present time?
"Clinicaltrials.gov reports that this medical trial is not actively enrolling at the moment, as it was posted on September 1st and last edited on September 14th. Nonetheless, there are 426 other clinical trials searching for volunteers right now."
Answered by AI
Who else is applying?
What site did they apply to?
Montefiore Bronx Health Collective
What portion of applicants met pre-screening criteria?
Did not meet criteria
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