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Farming for Life - Health Impact of Organic Vegetable Prescriptions for Adults Living With or at Risk of Type 2 Diabetes

NCT03940300 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 303

Last updated 2022-06-30

No results posted yet for this study

Summary

Farming for Life aims to determine the health impacts of providing weekly "prescriptions" of fresh organic vegetables to adults living with or at risk of type 2 diabetes. Over 4 years, up to 400 adults diagnosed with or at high risk of developing type 2 diabetes will be engaged for 3 months each, and receive weekly doses of locally-grown organic vegetable prescriptions. The end-points for comparison will be changes in blood pressure, weight, waist circumference, glycemic control \[defined as Time in Range (TIR) (70-140mg/dl)\] using continuous glucose monitoring (CGM), and HbA1c levels (a measure of long-term blood glucose level control) after 3 months compared to baseline measurements. Additional assessments will be made on the impact of the organic vegetable prescriptions on food security. At an optional Visit 13, offered 6 months after Visit 1, an additional health screening will be conducted.

Prevalence and risk of type 2 diabetes in the US is disproportionately high among low income and minority groups and is exasperated by high levels of food insecurity. The investigators hypothesize that improving access to fresh organic vegetables will result in measurable health outcomes for adults with type 2 diabetes and those at risk of developing the condition. This represents a promising and potentially cost-effective strategy for improving diabetes outcomes at a population level, particularly among low income, minority populations with type 2 diabetes.

Conditions

  • Diabetes Mellitus, Type 2
  • Food Supply
  • Poverty
  • Minority Health
  • Obesity

Interventions

DIETARY_SUPPLEMENT

Fresh organic vegetables

Individual participation in this program will take 12 weeks, from screening and enrollment through evaluation. Once enrolled, visits will occur on a weekly basis to ensure that participants receive each week's "dose" of fresh organic vegetables. At an optional Visit 13, offered 6 months after Visit 1, an additional health screening will be conducted.

Sponsors & Collaborators

  • United States Department of Agriculture (USDA)

    collaborator FED

  • Sansum Diabetes Research Institute

    lead OTHER

Principal Investigators

  • David Kerr, M.D. · Sansum Diabetes Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-28
Primary Completion
2022-05-09
Completion
2022-05-09

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03940300 on ClinicalTrials.gov