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Behavioural Intervention
Food as Medicine for Cardiometabolic Health
N/A
Recruiting
Led By Christina D Economos, PhD
Research Sponsored by Tufts University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month study period for each participant
Awards & highlights
No Placebo-Only Group
Summary
This trial focuses on improving the health of residents in the Mississippi Delta, who have faced food insecurity and poverty due to historical factors. The project aims to provide a "Food is Medicine" intervention through distributing
Who is the study for?
The trial is for residents of Bolivar, Washington, and Sunflower counties in Mississippi who are experiencing food insecurity and have cardiometabolic risk factors like diabetes, high blood pressure, or obesity. Participants should be part of the health disparity population with a significant number living at or below poverty level.
What is being tested?
The Delta GREENS project tests a 'Food is Medicine' intervention to improve health outcomes. It provides fruit and vegetable produce boxes along with nutrition education materials to one group (intervention), while another group (control) will receive these after study activities.
What are the potential side effects?
Since this intervention involves healthy eating through increased fruits and vegetables consumption, there are no direct medical side effects expected. However, changes in diet may initially cause digestive adjustments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 month study period for each participant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month study period for each participant
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in hemoglobin A1c (HbA1c)
Secondary study objectives
Change in BMI
Change in LDL cholesterol
Change in blood pressure
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
The intervention involves regularly distributed fruit and vegetable produce boxes as well as nutrition education materials to the intervention group.
Group II: ControlActive Control1 Intervention
The control group will receive produce boxes later, after they complete study activities.
Find a Location
Who is running the clinical trial?
Reuben V. Anderson Center for Justice at TougalooUNKNOWN
Tufts UniversityLead Sponsor
270 Previous Clinical Trials
594,591 Total Patients Enrolled
Tougaloo College, MississippiUNKNOWN
Delta Health Center, MississippiUNKNOWN
National Institute on Minority Health and Health Disparities (NIMHD)NIH
444 Previous Clinical Trials
1,413,211 Total Patients Enrolled
Christina D Economos, PhDPrincipal InvestigatorTufts University
1 Previous Clinical Trials
2,646 Total Patients Enrolled