Diabetes MellitusNCT05144750
Fruit and Vegetable Prescription in the Community Health Center Setting
A study testing Fruit and Vegetable Prescription in people with Diabetes Mellitus and Diabetes Mellitus, Type 2, run by Wholesome Wave at 1 site in United States.
Trial summary
The proposed study examines the implementation and efficacy of a fruit and vegetable incentive program in a population of adults with diabetes at a community health center (CHC) in California. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Poverty
- What is being tested?
- Fruit and Vegetable Prescription
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2021to 23 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes
- Low Income
- Patient of OCH
Who cannot join
- Under 18
- Does not speak Spanish or English
Trial locations and contacts
1 site in 1 country.
About this study
The proposed study examines the implementation and efficacy of a fruit and vegetable incentive program in a population of adults with diabetes at a community health center (CHC) in California. Additionally, we seek to understand the impact of this program on the participants with particular attention to their experience and point of view. To better understand the program and its impact, a mixed methods approach will be used.
Read the detailed description
The proposed research will utilize a mixed methods approach with both qualitative and quantitative methods to assess the process and impact of a fruit and vegetable incentive program administered in a community clinic that serves a population that is low-income in Sacramento, California.
Sacramento County has a population of 1.5 million people and 500,000 people living in the city of Sacramento proper. The poverty rate of the county over all is 12.6% and the city is 16.6%. The most recent estimate of county level food insecurity is 12%, which is consistent with the national average; however, the estimated rate during the COVID 19 pandemic is 16.5%. Sacramento also serves as an ideal region for intervention because there is a strong community partner with the CHC, One Community Health (OCH) and there are regionally accessible Walmart stores at which the fruit and vegetable incentives (i.e., Walmart gift cards) can be used. Participants in the study will receive up to $400 in fruit and vegetable vouchers over 8 months, $50 in voucher given per household each month (paused if no voucher redemption within prior 2 months).
The intervention adds a $50 monthly fruit and vegetable voucher, and text reminder and educational text messages (recipes/tips) to the Standard of Care for patients.
Standard Care for Patients at OCH: Patients/participants will be able to regularly meet with their healthcare team which includes but is not limited to a primary care physician, nursing staff, dietitians and other providers as needed. All care is based on evidence-based best clinical practices and the patient's voluntary involvement with their providers.
Fruit and Vegetable Incentive: During the 8-month intervention period, registered program participants can receive $50 monthly through the reloadable Walmart gift card, which can only be used to purchase fresh fruits and vegetables. The total incentive will be $400 for the eight-month program. Each month, program participants will be able to receive their monthly $50 incentive, providing their balance at the time of the reload does not exceed $100, due to two months of inactivity. Monthly reload plan will be made based on available balance during the first week of each month, with the reload planned for the 15th of each month.
Text Communication: Participants will share a text-enabled phone number with Wholesome Wave for Wholesome Wave to send text reminders to shop and utilize incentives, likely 2 times per month. Wholesome Wave will also share text messages that are consistent with the messages that the OCH dietitians are offering in their standard care, including recipes and tips.
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Poverty
- Being tested
- Fruit and Vegetable Prescription
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruit and Vegetable PrescriptionBehavioural
Also called Fruit and Vegetable Incentive
The intervention adds a $50 monthly fruit and vegetable voucher, and text reminder and educational text messages (recipes/tips) to the Standard of Care for patients.
Standard Care for Patients at OCH: Patients will be able to regularly meet with their healthcare team.
Fruit and Vegetable Incentive: During the 8-month intervention period, registered program participants can receive $50 monthly through the reloadable Walmart gift card, which can only be used to purchase fresh fruits and vegetables. The total incentive will be $400 for the eight-month program.
Text Communication: Wholesome Wave will share text reminders to shop and utilize incentives. Wholesome Wave will also share text messages that are consistent with the messages that the OCH dietitians are offering in their standard care, including recipes and tips.
| Study group | Role | What they receive |
|---|---|---|
| Fruit and Vegetable Prescription Program Cohort | Experimental | All participants received the program intervention. Receives: Behavioral: Fruit and Vegetable Prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index from Baseline to End of Program
Body mass index was calculated from height in meters and weight in kilograms: Height and Weight will be collected at months 1, 4 and 8 and at any additional clinic visits when appropriate.
Weight and height will be combined to report BMI in kg/m^2
Measured: All clinical measurements were collected at month 1 (baseline) and 8 (completion)
Change in HbA1c from Baseline to End of Program
Glycated hemoglobin A1c (HbA1c) was used to measure the average plasma glucose concentration. HbA1c will be measured using a finger-prick test. HbA1c will be reported as HbA1c% and Blood Glucose (mmol/L). Change in HbA1C will be calculated as end of program HbA1c% - baseline HbA1c%.
Measured: All clinical measurements were collected at month 1 (baseline) to 8 (completion)
Glycemic Control
Glycemic control: Glycated hemoglobin A1c (HbA1c) will be used to measure the average plasma glucose concentration. HbA1c will be measured using a finger-prick test. HbA1c will be reported as HbA1c% and Blood Glucose (mmol/L). Glycemic control will be determined inline with American Diabetes Association guidelines. According to the ADA HbA1C values lower than 5.7% represents a normal range, between 5.7% and 6.5% is prediabetes and greater than 6.5% is diabetes.
Measured: All clinical measurements were collected at month 1 (baseline) and 8 (completion)
Change in Blood Lipids HDL Ratio from Baseline to end of Program
Blood lipids: Values of total cholesterol (Tchol), triglycerides (TG), and high-density lipoprotein (HDL) will be obtained by clinical staff at OCH and run through their typical lab procedures that are part of standard of care, the values will be shared with researchers for months 1 and 8. HDL:Tchol ratio will also be computed. Change in HDL ration will be calculated as End of Program HDL ratio- beginning of the program HDL ratio.
Measured: All clinical measurements were collected at month 1 (baseline) and 8 (completion)
Change in Blood Lipids LDL Ratio from Baseline to end of Program
Blood lipids: Values of total cholesterol (Tchol), triglycerides (TG), and high-density lipoprotein (HDL) will be obtained by clinical staff at OCH and run through their typical lab procedures that are part of standard of care, the values will be shared with researchers for months 1 and 8. Serum low-density lipoprotein (LDL) will be calculated using the following formula LDL = Tchol - (TG/5 + HDL). Change in LDL ratio will be calculated as End of Program LDL ratio- beginning of the program LDL ratio.
Measured: All clinical measurements were collected at month 1 (baseline) and 8 (completion)
Change in Blood Pressure from Baseline to end of Program
Blood pressure: Blood pressure will be collected at by clinical staff at OCH at months 1 and 8 and at other clinical appointments as is medically appropriate, using an automatic blood pressure measurement device. Blood pressure will be measures as Systolic mm Hg/ diastolic mm Hg. Following the standards delineated by the CDC, systolic: less than 120 mm Hg diastolic: less than 80 mm Hg; systolic: 120-139 mm Hg diastolic: 80-89 mm Hg; and systolic: 140 mm Hg or higher diastolic: 90 mm Hg or higher. Change in blood pressure will be calculated change in (8 months systolic-1 month systolic) systolic over the change in diastolic (8 months diastolic-1 month diastolic).
Measured: All clinical measurements were collected at month 1 (baseline) and 8 (completion)
Change in Food Security
Food security will be measured using the USDA Household Food Security Measure. The score will be calculated following the USDA HFSM guide and change in food security will be reported as end of program score - beginning of program score.
Measured: Month 1(baseline) and 8 (completion)
Secondary outcomes (2)
Fruit and Vegetable Consumption
Fruit and vegetable consumption data will be measured using a short form fruit and vegetable food frequency questionnaire. The food frequency questionnaire will be scored and change in consumption will be calculated as end of program score - start of program score.
Measured: Month 1(baseline) and 8 (completion)
Self Reported Improved Health
Self-reported improved health will be measured using the RAND single-item measure. Change in score will be calculated as change in mean.
Measured: Month 1(baseline) and 8 (completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start6 Dec 2021
- Primary completion23 Feb 2023
- Study completion23 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wholesome Wave
- Sponsor type
- University, hospital or other
- Collaborators
- One Community Health, Yale-Griffin Prevention Research Center
- Responsible party
- Sponsor
- Investigators
- Kathleen Duffany, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144750
- Sponsor's protocol ID
- 2000030975
- Status last verified
- Feb 2024
- First submitted
- 3 Nov 2021
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fruit and Vegetable Prescription in the Community Health Center Setting
- ClinicalTrials.gov ID
- NCT05144750
- Acronym / sponsor ID
- 2000030975
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Poverty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Wholesome WaveUniversity, hospital or other
- Collaborators
- One Community Health, Yale-Griffin Prevention Research Center
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study examines the implementation and efficacy of a fruit and vegetable incentive program in a population of adults with diabetes at a community health center (CHC) in California. Additionally, we seek to understand the impact of this program on the participants with particular attention to their experience and point of view. To better understand the program and its impact, a mixed methods approach will be used.
Detailed description
The proposed research will utilize a mixed methods approach with both qualitative and quantitative methods to assess the process and impact of a fruit and vegetable incentive program administered in a community clinic that serves a population that is low-income in Sacramento, California.
Sacramento County has a population of 1.5 million people and 500,000 people living in the city of Sacramento proper. The poverty rate of the county over all is 12.6% and the city is 16.6%. The most recent estimate of county level food insecurity is 12%, which is consistent with the national average; however, the estimated rate during the COVID 19 pandemic is 16.5%. Sacramento also serves as an ideal region for intervention because there is a strong community partner with the CHC, One Community Health (OCH) and there are regionally accessible Walmart stores at which the fruit and vegetable incentives (i.e., Walmart gift cards) can be used. Participants in the study will receive up to $400 in fruit and vegetable vouchers over 8 months, $50 in voucher given per household each month (paused if no voucher redemption within prior 2 months).
The intervention adds a $50 monthly fruit and vegetable voucher, and text reminder and educational text messages (recipes/tips) to the Standard of Care for patients.
Standard Care for Patients at OCH: Patients/participants will be able to regularly meet with their healthcare team which includes but is not limited to a primary care physician, nursing staff, dietitians and other providers as needed. All care is based on evidence-based best clinical practices and the patient's voluntary involvement with their providers.
Fruit and Vegetable Incentive: During the 8-month intervention period, registered program participants can receive $50 monthly through the reloadable Walmart gift card, which can only be used to purchase fresh fruits and vegetables. The total incentive will be $400 for the eight-month program. Each month, program participants will be able to receive their monthly $50 incentive, providing their balance at the time of the reload does not exceed $100, due to two months of inactivity. Monthly reload plan will be made based on available balance during the first week of each month, with the reload planned for the 15th of each month.
Text Communication: Participants will share a text-enabled phone number with Wholesome Wave for Wholesome Wave to send text reminders to shop and utilize incentives, likely 2 times per month. Wholesome Wave will also share text messages that are consistent with the messages that the OCH dietitians are offering in their standard care, including recipes and tips.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fruit and Vegetable Prescription Program Cohort | Experimental | Behavioral: Fruit and Vegetable PrescriptionAll participants received the program intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 Diabetes
- Low Income
- Patient of OCH
Key exclusion criteria (2 listed)
- Under 18
- Does not speak Spanish or English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fruit and Vegetable PrescriptionAlso: Fruit and Vegetable IncentiveThe intervention adds a $50 monthly fruit and vegetable voucher, and text reminder and educational text messages (recipes/tips) to the Standard of Care for patients. Standard Care for Patients at OCH: Patients will be able to regularly meet with their healthcare team. Fruit and Vegetable Incentive: During the 8-month intervention period, registered program participants can receive $50 monthly through the reloadable Walmart gift card, which can only be used to purchase fresh fruits and vegetables. The total incentive will be $400 for the eight-month program. Text Communication: Wholesome Wave will share text reminders to shop and utilize incentives. Wholesome Wave will also share text messages that are consistent with the messages that the OCH dietitians are offering in their standard care, including recipes and tips. | Behavioural | Fruit and Vegetable Prescription Program Cohort |
Primary outcome
Change in Body Mass Index from Baseline to End of Program
Time frame: All clinical measurements were collected at month 1 (baseline) and 8 (completion)
Body mass index was calculated from height in meters and weight in kilograms: Height and Weight will be collected at months 1, 4 and 8 and at any additional clinic visits when appropriate. Weight and height will be combined to report BMI in kg/m^2
Change in HbA1c from Baseline to End of Program
Time frame: All clinical measurements were collected at month 1 (baseline) to 8 (completion)
Glycated hemoglobin A1c (HbA1c) was used to measure the average plasma glucose concentration. HbA1c will be measured using a finger-prick test. HbA1c will be reported as HbA1c% and Blood Glucose (mmol/L). Change in HbA1C will be calculated as end of program HbA1c% - baseline HbA1c%.
Glycemic Control
Time frame: All clinical measurements were collected at month 1 (baseline) and 8 (completion)
Glycemic control: Glycated hemoglobin A1c (HbA1c) will be used to measure the average plasma glucose concentration. HbA1c will be measured using a finger-prick test. HbA1c will be reported as HbA1c% and Blood Glucose (mmol/L). Glycemic control will be determined inline with American Diabetes Association guidelines. According to the ADA HbA1C values lower than 5.7% represents a normal range, between 5.7% and 6.5% is prediabetes and greater than 6.5% is diabetes.
Change in Blood Lipids HDL Ratio from Baseline to end of Program
Time frame: All clinical measurements were collected at month 1 (baseline) and 8 (completion)
Blood lipids: Values of total cholesterol (Tchol), triglycerides (TG), and high-density lipoprotein (HDL) will be obtained by clinical staff at OCH and run through their typical lab procedures that are part of standard of care, the values will be shared with researchers for months 1 and 8. HDL:Tchol ratio will also be computed. Change in HDL ration will be calculated as End of Program HDL ratio- beginning of the program HDL ratio.
Change in Blood Lipids LDL Ratio from Baseline to end of Program
Time frame: All clinical measurements were collected at month 1 (baseline) and 8 (completion)
Blood lipids: Values of total cholesterol (Tchol), triglycerides (TG), and high-density lipoprotein (HDL) will be obtained by clinical staff at OCH and run through their typical lab procedures that are part of standard of care, the values will be shared with researchers for months 1 and 8. Serum low-density lipoprotein (LDL) will be calculated using the following formula LDL = Tchol - (TG/5 + HDL). Change in LDL ratio will be calculated as End of Program LDL ratio- beginning of the program LDL ratio.
Change in Blood Pressure from Baseline to end of Program
Time frame: All clinical measurements were collected at month 1 (baseline) and 8 (completion)
Blood pressure: Blood pressure will be collected at by clinical staff at OCH at months 1 and 8 and at other clinical appointments as is medically appropriate, using an automatic blood pressure measurement device. Blood pressure will be measures as Systolic mm Hg/ diastolic mm Hg. Following the standards delineated by the CDC, systolic: less than 120 mm Hg diastolic: less than 80 mm Hg; systolic: 120-139 mm Hg diastolic: 80-89 mm Hg; and systolic: 140 mm Hg or higher diastolic: 90 mm Hg or higher. Change in blood pressure will be calculated change in (8 months systolic-1 month systolic) systolic over the change in diastolic (8 months diastolic-1 month diastolic).
Change in Food Security
Time frame: Month 1(baseline) and 8 (completion)
Food security will be measured using the USDA Household Food Security Measure. The score will be calculated following the USDA HFSM guide and change in food security will be reported as end of program score - beginning of program score.
2 secondary outcomes
Fruit and Vegetable Consumption
Time frame: Month 1(baseline) and 8 (completion)
Self Reported Improved Health
Time frame: Month 1(baseline) and 8 (completion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Duffany principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fruit and Vegetable Prescription in people with Diabetes Mellitus and Diabetes Mellitus, Type 2, run by Wholesome Wave at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index from Baseline to End of Program (time frame: All clinical measurements were collected at month 1 (baseline) and 8 (completion)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.