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

NCT03940300 | Terminated

• 1 other identifier: 2018-01793
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Diabetes Mellitus, Type 2; food insecurity; food prescriptions; minority; low-income

Outcome Measures

Primary Outcomes (4)

• Improve cardio-metabolic health in adults with (non-insulin treated) type 2 diabetes or at risk for type 2 diabetes as measured by blood pressure.

  Cardio-metabolic health is described by lower blood pressure (systolic and diastolic pressure, mmHg).

  12 weeks

• Improve cardio-metabolic health in adults with (non-insulin treated) type 2 diabetes or at risk for type 2 diabetes as measured by body mass index.

  Cardio-metabolic health is described by lower body mass index (kg/m2).

  12 weeks

• Improve cardio-metabolic health in adults with (non-insulin treated) type 2 diabetes or at risk for type 2 diabetes as measured by waist circumference .

  Cardio-metabolic health is described by decreased waist circumference (cm).

  12 weeks

• Improve cardio-metabolic health in adults with (non-insulin treated) type 2 diabetes or at risk for type 2 diabetes as measured by hemoglobin A1c.

  Cardio-metabolic health is described by decreased hemoglobin A1c (%).

  12 weeks

Secondary Outcomes (2)

• Improve food security for adults with or at risk for type 2 diabetes assessed by U.S. Household Food Security Survey Module: Six-item short form

  Visit 1, Week 1 and Visit 12, Week 12

• Improve glycemic control measured by continuous glucose monitoring (CGM)

  Visit 1, Week 1 to Visit 3, Week 3 and Visit 10, Week 10 to Visit 12, Week 12

Other Outcomes (14)

• Acculturation measured by the Brief Acculturation Scale for Hispanics (BASH)

  Visit 1, Week 1

• Socio-demographics assessed by questionnaire

  Visit 1, Week 1

• Concurrent medications assessed by visual inspection

  Visit 1, Week 1

Study Arms (1)

Adults with or risk for Type 2 Diabetes

EXPERIMENTAL

All adult individuals with (non-insulin treated) or at risk for type 2 diabetes are in the treatment group and will receive prescriptions of fresh organic vegetables on a weekly basis for 10 weeks.

Dietary Supplement: Fresh organic vegetables

Interventions

Fresh organic vegetables DIETARY_SUPPLEMENT

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.

Adults with or risk for Type 2 Diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥ 18 years of age at Visit 1
• Self-reported diagnosis of type 2 diabetes OR self-reported as at high risk for developing type 2 diabetes
• Based on program staff's judgment, subject must have a good understanding, ability, and willingness to adhere to the protocol

You may not qualify if:

• Currently taking insulin as treatment for diabetes
• Pregnant
• Any active clinically significant disease or disorder, which in the investigator's opinion could interfere with the participation in the trial
• Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding comprehension of program activities and informed consent
• Participation in other trials involving medication or device within 1 month prior to Farming for Life enrollment
• Known or suspected abuse of alcohol, narcotics, or illicit drugs

Sponsors & Collaborators

• Sansum Diabetes Research Institute: lead
• United States Department of Agriculture (USDA): collaborator

Study Sites (1)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

Related Publications (1)

• Kerr D, Barua S, Glantz N, Conneely C, Kujan M, Bevier W, Larez A, Sabharwal A. 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. BMJ Nutr Prev Health. 2020 Oct 5;3(2):239-246. doi: 10.1136/bmjnph-2020-000133. eCollection 2020 Dec.

  PMID: 33521534 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Kerr, M.D.

  Sansum Diabetes Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible and consented participants in this program will be asked to complete 12 visits. Over the course of these visits, participants will collect 10 weekly organic vegetable prescriptions signed by a qualified medical practitioner, as well as complete health screenings and questionnaires during the first and last visits. At each prescription pick-up visit, each participant will receive a week's "dose" of organic vegetables. The outcome measures will be collected at Visit 1 after obtaining informed consent and at Visit 12 after the completion of 10 weeks of prescriptions. Additionally, participants will be invited to submit via cell phone photographs of meals featuring their prescribed vegetables. At an optional Visit 13, offered 6 months after Visit 1, an additional health screening will be conducted.

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 7, 2019
• Study Start: January 28, 2019
• Primary Completion: May 9, 2022
• Study Completion: May 9, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Locations

US (1)