NCT03940300: FFL

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

Terminated NA Last updated 30 June 2022

What this trial tests

NA trial testing Fresh organic vegetables in Diabetes Mellitus, Type 2 in 303 participants. Terminated before completion.

Timeline

28 January 2019

Primary endpoint
9 May 2022

9 May 2022

Quick facts

Lead sponsor	Sansum Diabetes Research Institute
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	303
Start date	28 January 2019
Primary completion	9 May 2022
Estimated completion	9 May 2022
Sites	1 location across United States

Drugs / interventions tested

• Fresh organic vegetables

Conditions studied

• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
• Food Supply — all drugs for Food Supply →
• Poverty — all drugs for Poverty →
• Minority Health — all drugs for Minority Health →

Sponsor

Sansum Diabetes Research Institute

Who can join

18 and older, any sex, with Diabetes Mellitus, Type 2 or Food Supply. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Farming for life: impact of medical prescriptions for fresh vegetables on cardiometabolic health for adults with or at risk of type 2 diabetes in a predominantly Mexican-American population.
   Kerr D, Barua S, Glantz N, Conneely C, et al · · 2020 · cited 21× · PMID 33521534 · DOI 10.1136/bmjnph-2020-000133
2. Evaluating HbA_1c-to-average glucose conversion with patient-specific kinetic models for diverse populations.
   Sato Imuro SE, Sabharwal A, Bevier W, Kerr D. · · 2024 · cited 5× · PMID 39333162 · DOI 10.1038/s41598-024-72837-7
3. Temporal changes in bio-behavioral and glycemic outcomes following a produce prescription program among predominantly Hispanic/Latino adults with or at risk of type 2 diabetes.
   Sato Imuro SE, Sabharwal A, Conneely C, Glantz N, et al · · 2023 · cited 2× · PMID 37533982 · DOI 10.1016/j.heliyon.2023.e18440