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

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ClinicalTrials.gov Identifier: NCT03940300
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : May 10, 2019
Sponsor:
Collaborator:
United States Department of Agriculture (USDA)
Information provided by (Responsible Party):
Sansum Diabetes Research Institute

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Food Supply Poverty Minority Health Obesity Dietary Supplement: Fresh organic vegetables Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Farming for Life - a Program to Prescribe Fresh Organic Vegetables for Adults Living With or at Risk of Type 2 Diabetes.
Actual Study Start Date : January 28, 2019
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Adults with or risk for Type 2 Diabetes
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
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.




Primary Outcome Measures :
  1. 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. [ Time Frame: 12 weeks ]
    Cardio-metabolic health is described by lower blood pressure (systolic and diastolic pressure, mmHg).

  2. 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. [ Time Frame: 12 weeks ]
    Cardio-metabolic health is described by lower body mass index (kg/m2).

  3. 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 . [ Time Frame: 12 weeks ]
    Cardio-metabolic health is described by decreased waist circumference (cm).

  4. 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. [ Time Frame: 12 weeks ]
    Cardio-metabolic health is described by decreased hemoglobin A1c (%).


Secondary Outcome Measures :
  1. 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 [ Time Frame: Visit 1, Week 1 and Visit 12, Week 12 ]
    Food security or insecurity assessed by a six-item short form developed by the Economic Research Service, United States Department of Agriculture (USDA), September 2012. Questionnaire consists of 6 questions regarding food security or insecurity, and the choices for answers are "often true", "sometimes true", "never true", and "don't know or refused". There are no better or worse values.

  2. Improve glycemic control measured by continuous glucose monitoring (CGM) [ Time Frame: Visit 1, Week 1 to Visit 3, Week 3 and Visit 10, Week 10 to Visit 12, Week 12 ]
    Time in Range defined as blood glucose, 70 - 140 mg/dL, over 2 weeks [percentage of glucose readings, or hours per day] will be measured by continuous glucose monitoring (CGM) in a sub-set of participants.


Other Outcome Measures:
  1. Acculturation measured by the Brief Acculturation Scale for Hispanics (BASH) [ Time Frame: Visit 1, Week 1 ]
    BASH is a participant reported questionnaire to measure acculturation. Responses are scored as 1 = only Spanish, 2 = Spanish more than English, 3 = Spanish and English equally, 4 = English more than Spanish, and 5 = only English. Items are summed and divided by the number of items. Low acculturation is less than or equal to 3.0, and high acculturation is greater than or equal to 3.0.

  2. Socio-demographics assessed by questionnaire [ Time Frame: Visit 1, Week 1 ]
    Socio-demographics measured by questionnaire - including age, gender, self-identified race/ethnicity, contact information, number in household, insurance status, insurance type and payer, country of birth, and occupation.

  3. Concurrent medications assessed by visual inspection [ Time Frame: Visit 1, Week 1 ]
    Medications currently being taken will be documented by visual inspection of medication containers

  4. General health measured by questionnaire [ Time Frame: Visit 1, Week 1 and Visit 12, Week 12 ]
    Pre and post program questions regarding general health measured by a 4 point scale (1 poor, 2 fair, 3 good, 4 excellent)

  5. Food consumption behavior measured by questionnaire [ Time Frame: Visit 1, Week 1 and Visit 12, Week 12 ]
    Pre and post program questions regarding food consumption behavior measured by a 4 point scale (1 strongly disagree, 2 disagree, 3 agree, 4 strongly agree)

  6. Factors influencing food consumption measured by questionnaire [ Time Frame: Visit 1, Week 1 and Visit 12, Week 12 ]
    Pre and post program questions regarding factors influencing food consumption measured by a 4 point scale (1 not important at all, 2 a little important, 3 important, 4 extremely important)

  7. Sleep evaluation by questionnaire [ Time Frame: Visit 1, Week 1 and Visit 12, Week 12 ]
    Pre and post program Likhert scale to answer the question, "How would you rate your sleep over the course of the past 7 days?," from worst sleep to best sleep

  8. Mood evaluation by questionnaire [ Time Frame: Visit 1, Week 1 and Visit 12, Week 12 ]
    Pre and post program Likhert scale to answer the question, "How would you rate your mood over the course of the past 7 days?," from worst mood to best mood

  9. Pain evaluation by questionnaire [ Time Frame: Visit 1, Week 1 and Visit 12, Week 12 ]
    Pre and post program Likhert scale to answer the question, "How would you rate your level of pain over course of the past 7 days?," from worst pain to no pain

  10. Physical activity evaluation by questionnaire [ Time Frame: Visit 1, Week 1 and Visit 12, Week 12 ]
    Pre and post program questionnaire about daily physical activity

  11. Total daily tortilla consumption evaluation [ Time Frame: Visit 1, Week 1 and Visit 12, Week 12 ]
    The number of flour and/or corn tortillas consumed daily for the past 30 days is estimated

  12. Daily sugar-sweetened beverage consumption evaluation [ Time Frame: Visit 1, Week 1 and Visit 12, Week 12 ]
    Daily sugary drink consumption is measured by the 2 questions in the Sugar Sweetened Beverages module of the Behavioral Risk Factor Surveillance System Questionnaire (BRFSS) from the Centers for Disease Control.

  13. Number of times per week eating meals prepared away from home [ Time Frame: Visit 1, Week 1 and Visit 12, Week 12 ]
    National Health and Nutrition Examination Survey (NHANES) 2017-2018 question asked - During the past 7 days, how many meals did you get that were prepared away from home in places such as restaurants, fast food places, food stands, grocery stores, or from vending machines?

  14. Participant experience with the program evaluated by questionnaire [ Time Frame: Visit 12, Week 12 ]
    Questionnaire regarding participant's experience with the study program consists of 9 questions. Participants are asked general questions about the program's impact on health, difficulties in participating, ease of participating, what should be changed, what should be kept, vegetable consumption, and would friends or relatives be interested in this program.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940300


Contacts
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Contact: Mary Kujan 805-335-0309 mkujan@sansum.org
Contact: Casey Conneely 805-699-1519 cconneely@sansum.org

Locations
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United States, California
Sansum Diabetes Research Institute Recruiting
Santa Barbara, California, United States, 93105
Contact: Mary Kujan    805-335-0309    mkujan@sansum.org   
Contact: Casey Conneely    805-699-1519    cconneely@sansum.org   
Sponsors and Collaborators
Sansum Diabetes Research Institute
United States Department of Agriculture (USDA)
Investigators
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Principal Investigator: David Kerr, M.D. Sansum Diabetes Research Institute

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Responsible Party: Sansum Diabetes Research Institute
ClinicalTrials.gov Identifier: NCT03940300     History of Changes
Other Study ID Numbers: 2018-01793
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sansum Diabetes Research Institute:
Diabetes Mellitus, Type 2
food insecurity
food prescriptions
minority
low-income

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases