Type 2 DiabetesPPT2DNCT06058338
Pathway for Produce Prescriptions in Diabetes Management
A study testing Produce Prescription in people with Type 2 Diabetes, run by Gretchen Swanson Center for Nutrition at 5 sites in United States.
Trial summary
Fruit and vegetable (FV) intake decrease the risk of type 2 diabetes (T2D) and is important for T2D management but is difficult to achieve in adequate amounts for those with a low- income. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Produce Prescription
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 5 sitesUnited States
- Study dates
- 31 May 2023to 30 Aug 2024
- 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
- diagnosed with Type 2 diabetes
- have clinically screened positive for food insecurity and/or be income-eligible to receive Medicaid and/or SNAP-benefits
- ≥ 18 years of age, and
- be a patient at a participating healthcare site.
Who cannot join
- people who pregnant or nursing and
- plans to move away during the study period.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Chicago Botanic Gardens - Farm on Ogden
Chicago, Illinois, 60623
Parkview Hospital
Fort Wayne, Indiana, 46808
Virtua Health
Marlton, New Jersey, 08053
Market Umbrella
New Orleans, Louisiana, 70118
Presbyterian Healthcare Services
Santa Fe, New Mexico, 87507
About this study
Official title: Multi-level Evaluation of Produce Prescription Projects on Type 2 Diabetes-related Outcomes: A Pathway to Policy Change by Addressing Social Determinants of Health
Fruit and vegetable (FV) intake decrease the risk of type 2 diabetes (T2D) and is important for T2D management but is difficult to achieve in adequate amounts for those with a low- income. Produce Prescription (PPR) projects are an intervention aligned with the social determinants of health that help individuals with a low-income purchase FV by providing an incentive. The impacts of PPR projects on populations with T2D and a low-income is less understood. The Multi-level evaluation of Produce Prescription Projects on type 2 diabetes- related outcomes: A pathway to policy change by addressing social determinants of health study will determine the impact of PPR projects on hemo-globin A1c (HbA1c; primary outcome), fruit and vegetable intake (FVI), food security, and related behaviors among a diverse sample of PPR participants diagnosed with T2D and low-income (Aim 1), and will conduct a cost and cost-effective analysis of PPR projects (Aim 2), and a mixed methods process evaluation to understand feasibility and best practices for PPR projects for people with/at risk for T2D (Aim 3). We hypothesize that PPR participants will see greater declines in HbA1c and improvements in other health and food-related behaviors, compared to the Standard of Care. We will recruit five GusNIP PPR projects, whose healthcare partners serve patients with T2D, and who have participating and matched non-participating control populations. We will collect data at baseline and post-intervention using validated, survey modules, clinical measures, and cost data. Five types of data will be used for this project: 1.Health and healthcare utilization data from the EHR or point-of-care, 2.Participant survey data, 3.Qualitative data, 4.Program cost data (NOT human subjects), and 5.Process data (NOT human subjects). Information extracted from medical records includes HbA1c, weight, and blood pressure and will be collected at 2 time points (months 0,6), following their standard of care protocols. Staff will also extract healthcare utilization data (e.g., #primary care and #ER visits) from the EHR at each of site. Primary analyses will use an intention to treat strategy. Analysis will include a linear mixed-effect model to the HbA1c with an interaction between group and time to examine whether there is a difference in HbA1c trajectories between intervention and control groups. Similar models will be used to determine impact on each of the secondary outcomes (e.g., healthcare utilization, BMI).
- Conditions
- Type 2 Diabetes
- Being tested
- Produce Prescription
- Keywords
- Produce Prescriptions, Social Determinants of Health, Food Security
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Produce PrescriptionBehavioural
Produce prescriptions mitigate health and food access inequities by partnering with healthcare providers to prescribe fruits and vegetables via financial incentives to patients experiencing food insecurity, low income, and/or chronic disease(s) risk.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Intervention arm participants will receive produce prescription services for a defined period of time (4-6months) Receives: Behavioral: Produce Prescription |
| Control Arm | No intervention | Control arm participants will not receive produce prescriptions but will receive standard of care services for diabetes management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Participant HbA1c will be collected by point-of-care venipuncture or from lab draws in electronic medical records.
Measured: Months 0,6
Secondary outcomes (9)
Body Mass Index
Participant BMI will be calculated from height/weight measurements from electronic medical records.
Measured: Months 0,6
Blood pressure
Participant systolic and diastolic blood pressure measurements will be collected from electronic medical records.
Measured: Months 0,6
Fruit and vegetable intake
Participant fruit and vegetable intake as measured by the NCI/NIH Dietary Screener Questionnaire (DSQ) 10-item fruit and vegetable module.
Measured: Months 0,6
Food security
Participant food security status as measured by the USDA 6-item food security survey.
Measured: Months 0,6
Diabetes distress
Participant diabetes distress as measured by the Problem Areas in Diabetes Scale (PAID-5) using the scale of 0, not a problem, to 4, serious problem with higher scores indicating more emotional stress from living with diabetes
Measured: Months 0,6
Health-related Quality of Life
Participant health-related quality of life as measured by the Short Form (SF)-12 module that addresses 8 domains of physical and mental health along a scale ranging from 0 to 100, with higher scores indicating better physical and mental health functioning
Measured: Months 0,6
Self-efficacy
Participant self-efficacy for eating fruits and vegetables as measured by a single survey question using a 5 point scale from 0 to 5 with 0 indicating not at all confident and 5 indicating very confident.
Measured: Months 0,6
Self-reported health
Participant self-reported health status as measured by a single survey question using a 5 point scale from 0 to 5 with 0 indicating poor health and 5 indicating excellent health
Measured: Months 0,6
Program satisfaction
Participant produce prescription program satisfaction as measured by a single survey question using a 5 point scale from 0 to 5 with 0 indicating very negative satisfaction and 5 indicating very positive satisfaction
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start31 May 2023
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gretchen Swanson Center for Nutrition
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association, University of Colorado, Denver, University of California, San Francisco, Children's Hospital Medical Center, Cincinnati, Lawndale Christian Health Center, Virtua Health, Parkview Hospital, Indiana, Presbyterian Healthcare Services, Market Umbrella
- Responsible party
- Principal investigator, Carmen Byker Shanks, Gretchen Swanson Center for Nutrition
- Investigators
- Carmen Byker Shanks, PhD, Principal investigator, Gretchen Swanson Center for Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058338
- Sponsor's protocol ID
- 7-22-ICTSN-40
- Acronym
- PPT2D
- Status last verified
- Oct 2023
- First submitted
- 22 Sep 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-level Evaluation of Produce Prescription Projects on Type 2 Diabetes-related Outcomes: A Pathway to Policy Change by Addressing Social Determinants of Health
- ClinicalTrials.gov ID
- NCT06058338
- Acronym / sponsor ID
- PPT2D / 7-22-ICTSN-40
- Conditions
- Type 2 Diabetes
- Keywords
- Produce Prescriptions, Social Determinants of Health, Food Security
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Gretchen Swanson Center for NutritionUniversity, hospital or other
- Collaborators
- American Diabetes Association, University of Colorado, Denver, University of California, San Francisco, Children's Hospital Medical Center, Cincinnati, Lawndale Christian Health Center, Virtua Health, Parkview Hospital, Indiana, Presbyterian Healthcare Services, Market Umbrella
- Study start
- 31 May 2023 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 28 Sep 2023 (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.
Fruit and vegetable (FV) intake decrease the risk of type 2 diabetes (T2D) and is important for T2D management but is difficult to achieve in adequate amounts for those with a low- income. Produce Prescription (PPR) projects are an intervention aligned with the social determinants of health that help individuals with a low-income purchase FV by providing an incentive. The impacts of PPR projects on populations with T2D and a low-income is less understood. The Multi-level evaluation of Produce Prescription Projects on type 2 diabetes- related outcomes: A pathway to policy change by addressing social determinants of health study will determine the impact of PPR projects on hemo-globin A1c (HbA1c; primary outcome), fruit and vegetable intake (FVI), food security, and related behaviors among a diverse sample of PPR participants diagnosed with T2D and low-income (Aim 1), and will conduct a cost and cost-effective analysis of PPR projects (Aim 2), and a mixed methods process evaluation to understand feasibility and best practices for PPR projects for people with/at risk for T2D (Aim 3). We hypothesize that PPR participants will see greater declines in HbA1c and improvements in other health and food-related behaviors, compared to the Standard of Care. We will recruit five GusNIP PPR projects, whose healthcare partners serve patients with T2D, and who have participating and matched non-participating control populations. We will collect data at baseline and post-intervention using validated, survey modules, clinical measures, and cost data. Five types of data will be used for this project: 1.Health and healthcare utilization data from the EHR or point-of-care, 2.Participant survey data, 3.Qualitative data, 4.Program cost data (NOT human subjects), and 5.Process data (NOT human subjects). Information extracted from medical records includes HbA1c, weight, and blood pressure and will be collected at 2 time points (months 0,6), following their standard of care protocols. Staff will also extract healthcare utilization data (e.g., #primary care and #ER visits) from the EHR at each of site. Primary analyses will use an intention to treat strategy. Analysis will include a linear mixed-effect model to the HbA1c with an interaction between group and time to examine whether there is a difference in HbA1c trajectories between intervention and control groups. Similar models will be used to determine impact on each of the secondary outcomes (e.g., healthcare utilization, BMI).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Produce PrescriptionIntervention arm participants will receive produce prescription services for a defined period of time (4-6months) |
| Control Arm | No intervention | –Control arm participants will not receive produce prescriptions but will receive standard of care services for diabetes management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosed with Type 2 diabetes
- have clinically screened positive for food insecurity and/or be income-eligible to receive Medicaid and/or SNAP-benefits
- ≥ 18 years of age, and
- be a patient at a participating healthcare site.
Key exclusion criteria (2 listed)
- people who pregnant or nursing and
- plans to move away during the study period.
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 |
|---|---|---|
| Produce PrescriptionProduce prescriptions mitigate health and food access inequities by partnering with healthcare providers to prescribe fruits and vegetables via financial incentives to patients experiencing food insecurity, low income, and/or chronic disease(s) risk. | Behavioural | Intervention Arm |
Primary outcome
Hemoglobin A1c
Time frame: Months 0,6
Participant HbA1c will be collected by point-of-care venipuncture or from lab draws in electronic medical records.
9 secondary outcomes
Body Mass Index
Time frame: Months 0,6
Blood pressure
Time frame: Months 0,6
Fruit and vegetable intake
Time frame: Months 0,6
Food security
Time frame: Months 0,6
Diabetes distress
Time frame: Months 0,6
Health-related Quality of Life
Time frame: Months 0,6
Self-efficacy
Time frame: Months 0,6
Self-reported health
Time frame: Months 0,6
Program satisfaction
Time frame: Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
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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.
Carmen Byker Shanks, PhD principal investigator
Gretchen Swanson Center for Nutrition
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Produce Prescription in people with Type 2 Diabetes, run by Gretchen Swanson Center for Nutrition at 5 sites 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 4 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: status not confirmed, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
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?
Hemoglobin A1c (time frame: Months 0,6). 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 5 Oct 2023.