Obesity Clinical Trial
— FFLOfficial title:
Farming for Life - a Program to Prescribe Fresh Organic Vegetables for Adults Living With or at Risk of Type 2 Diabetes.
Verified date | June 2022 |
Source | Sansum Diabetes Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 303 |
Est. completion date | May 9, 2022 |
Est. primary completion date | May 9, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Sansum Diabetes Research Institute | Santa Barbara | California |
Lead Sponsor | Collaborator |
---|---|
Sansum Diabetes Research Institute | United States Department of Agriculture (USDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Acculturation measured by the Brief Acculturation Scale for Hispanics (BASH) | 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. | Visit 1, Week 1 | |
Other | Socio-demographics assessed by questionnaire | 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. | Visit 1, Week 1 | |
Other | Concurrent medications assessed by visual inspection | Medications currently being taken will be documented by visual inspection of medication containers | Visit 1, Week 1 | |
Other | General health measured by questionnaire | Pre and post program questions regarding general health measured by a 4 point scale (1 poor, 2 fair, 3 good, 4 excellent) | Visit 1, Week 1 and Visit 12, Week 12 | |
Other | Food consumption behavior measured by questionnaire | 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) | Visit 1, Week 1 and Visit 12, Week 12 | |
Other | Factors influencing food consumption measured by questionnaire | 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) | Visit 1, Week 1 and Visit 12, Week 12 | |
Other | Sleep evaluation by questionnaire | 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 | Visit 1, Week 1 and Visit 12, Week 12 | |
Other | Mood evaluation by questionnaire | 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 | Visit 1, Week 1 and Visit 12, Week 12 | |
Other | Pain evaluation by questionnaire | 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 | Visit 1, Week 1 and Visit 12, Week 12 | |
Other | Physical activity evaluation by questionnaire | Pre and post program questionnaire about daily physical activity | Visit 1, Week 1 and Visit 12, Week 12 | |
Other | Total daily tortilla consumption evaluation | The number of flour and/or corn tortillas consumed daily for the past 30 days is estimated | Visit 1, Week 1 and Visit 12, Week 12 | |
Other | Daily sugar-sweetened beverage consumption evaluation | 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. | Visit 1, Week 1 and Visit 12, Week 12 | |
Other | Number of times per week eating meals prepared away from home | 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? | Visit 1, Week 1 and Visit 12, Week 12 | |
Other | Participant experience with the program evaluated by questionnaire | 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. | Visit 12, Week 12 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | 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. | Visit 1, Week 1 and Visit 12, Week 12 | |
Secondary | Improve glycemic control measured by continuous glucose monitoring (CGM) | 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. | Visit 1, Week 1 to Visit 3, Week 3 and Visit 10, Week 10 to Visit 12, Week 12 |
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