Diabetes Mellitus, Type 2FRESHNCT06211270
Food and Resources Expanded to Support Health and Type 2 Diabetes
A study testing FRESH in people with Diabetes Mellitus, Type 2, run by University of Arizona at 1 site in United States.
Trial summary
Food insecurity, poor nutrition, and economic disadvantage are critical social determinants of health that contribute to disparities in type 2 diabetes mellitus (T2DM), a serious diet-sensitive chronic disease affecting more than 20% of food insecure adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- FRESH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- adult (ages 18+); patient at El Rio Community Health Center; fluent in English or Spanish; physician diagnosis of T2DM; food insecure (based on a "yes" answer to the 2-item Hunger Vital Sign food security screening tool used by El Rio to screen patients); stable housing with access to a kitchen; U.S.-based address and telephone number; willingness to participate in all study activities (Section C.6) for the duration of the study (12 months on study, including 6 months of intervention).
Who cannot join
- diagnosed psychiatric disturbances or mental illness; physical limitations or medical conditions restricting ad libitum food intake (e.g., dysphagia); inability to read and write; no home phone or home address; not able to speak and read English or Spanish.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
El Rio Community Health Center
Tucson, Arizona, 85701
About this study
Official title: Food and Resources Expanded to Support Health and Type 2 Diabetes (FRESH-T2D)
Food insecurity, poor nutrition, and economic disadvantage are critical social determinants of health that contribute to disparities in type 2 diabetes mellitus (T2DM), a serious diet-sensitive chronic disease affecting more than 20% of food insecure adults. There is a demonstrable need for food-focused interventions to address the diet quality of persons with, or at risk of, T2DM. Completion of the pilot study will produce recruitment, retention, adherence, and cost data for a future definitive randomized controlled clinical trial, bringing us closer to the long-term goal of a tested, efficacious model of diabetes care coordinated across Federally Qualified Health Centers and food bank networks.
Read the detailed description
In 2020, more than 38.5 million (10.5%) U.S. households were without reliable access to sufficient quantities of affordable, nutritious food due to limited money or other resources. Food insecurity, poor nutrition, and economic disadvantage are critical social determinants of health that contribute to disparities in type 2 diabetes mellitus (T2DM), a serious diet-sensitive chronic disease affecting more than 20% of food insecure adults. Coping strategies favor inexpensive, ultra-processed foods that substantially diminish diet quality and are associated with increased incidence and severity of T2DM, including poorer glycemic control and excess body weight. Given that numerous social factors and systems contribute to and perpetuate food insecurity and poor diabetes outcomes, there is a demonstrable need for multilevel (individual, household, community) food-focused interventions to effectively and sustainably address the diet quality of persons with, or at risk of, T2DM. To date, no studies have rigorously tested whether intervention programs explicitly designed to improve both food and nutrition security of low-income persons with T2DM are feasibly delivered by personnel at a Federally Qualified Health Center (FQHC), acceptable to patients seeking care in their medical home, or are capable of producing clinically relevant changes in T2DM endpoints. These are questions will be explored in the proposed randomized wait-list controlled pilot study- Food and Resources Expanded to Support Health and Type 2 Diabetes (FRESH-T2DM)- in which a previously developed food and diabetes self-management education (DSME) intervention (FRESH) will be delivered to 50 adult FQHC patients with T2DM and food insecurity twice monthly, for 6 months. The FRESH intervention consists of bimonthly food provision; a series of recipes that feature FRESH foods; diabetes self-management education (DSME) resources; and four, 30-minute visits with an FQHC Registered Dietitian Nutritionist and Certified Diabetes Educator who will help participants utilize FRESH resources to meet personalized treatment goals. Building upon prior work and existing collaborations with colleagues at El Rio Community Health Center, a Federally Qualified Health Center serving >110,000 underinsured, uninsured patients and the Community Food Bank of Southern Arizona, a regional food bank serving 180,000 Arizonans across 5 counties, the Specific Aims are to: (Specific Aim 1) Assess the feasibility, acceptability, and participant uptake of the FRESH intervention, delivered to 50 food insecure adults with T2DM at their medical home, El Rio Community Health Center, and (Specific Aim 2) Explore changes in blood glucose control, diet quality, food security, diabetes self-care behaviors, and health-related quality of life among participants at 3 and 6 months. Completion of this pilot study -submitted in response to NIDDK PAS-20-160 -will produce data to inform the rationale and design of a future definitive randomized controlled clinical trial, including recruitment, retention, adherence, and cost data. The long-term goal is to produce a tested, efficacious model of coordinated care capable of replication and scaling across other FQHCs and food bank networks.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- FRESH
- 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.
FRESHBehavioural
FRESH-T2D Intervention consisting of bimonthly food, recipes, and diabetes self-management resources + 4 meetings with Registered Dietitian Nutritionists x 6 months duration
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | FRESH-T2D Intervention consisting of bimonthly food, recipes, and diabetes self-management resources + 4 meetings with Registered Dietitian Nutritionists x 6 months duration Receives: Behavioral: FRESH |
| Wait-Listed Control | Other | Standard of Care for El Rio Community Health Center persons with type 2 diabetes. Receives: Behavioral: FRESH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability Aim 1
How participants and those involved in implementing the program react to the intervention, assessed via qualitative in-depth interviews. Satisfaction with foods and resources, suggestions for improvement, perceived usefulness will be explored.
Measured: 6 months (post-intervention)
Demand
Intervention uptake (relevance of foods/resources/services provided, promoters and barriers to participation in the intervention, degree to which participants report using the intervention resources to influence T2DM, "fit" with daily life, cultural congruence) will be explored in brief surveys and qualitative in-depth interviews.
Measured: 6 months (post-intervention)
Implementation
The extent, likelihood, and manner in which the intervention is implemented as planned, including participant recruitment and retention rates and ease/burden associated with data collection methods will be estimated from research team logs, and qualitative in-depth interviews. Retention rate will be calculated at study end (12 months).
Measured: 3- and 6 months (post-intervention), and 12 months (follow-up)
Practicality
Adherence(# of boxes received, resources utilized, and RDN/CDE visits completed), will be calculated from research team logs. Costs, burden and benefit the participants and the FQHC will be evaluated using a bottom-up micro-costing approach - for participants, this will include time and resources spent in travel, and services, equipment, and food needed to meet program recommendations; for the FQHC, this includes direct medical and non-medical costs including personnel gross hourly salaries, intervention material costs (in partnership with the Food Bank), and overhead costs related to use of facilities for prevention services will be tracked and analyzed in partnership with FQHC data team members; 5) any adaptation or modifications of the intervention by the FQHC to accommodate patients and organization.
Measured: Throughout the intervention, and at 6 months (post-intervention)
Adaptation
Any modifications of the intervention by the FQHC to accommodate patients and organizational requirements and context will be explored through qualitative in-depth interviews with FQHC and Food Bank personnel.
Measured: 6 months (post-intervention)
Expansion
Potential for sustainability of the program at the FQHC, and expansion of the intervention across other FQHCs, and any positive or negative effects on the organization will be explored through qualitative in-depth interviews with FQHC personnel.
Measured: 6 months (post-intervention)
Integration
Integration of the FRESH intervention with provider care plans for patients, a systems-level change that would allow the program to be a reimbursable treatment, will be explored through qualitative in-depth interviews with FQHC personnel.
Measured: 6 months (post-intervention)
Secondary outcomes (9)
Demographics and Social Determinants of Health
Self-reported using the Protocol for Responding to and Assessing Patients' Assets, Risks, and Experiences (PRAPARE) Questionnaire, a screening tool used by Federally Qualified Health Centers to better understand social determinants of health.
Measured: Baseline, 3- and 6 months (post-intervention)
Glycated hemoglobin (HbA1c)
HbA1c is an established metric for long-term monitoring of blood glucose control in persons with T2DM. HbA1c will be collected by the research team using portable (point-of-care) capillary-based technology (Siemens Diagnostics DCA HbA1C analyzer).
Measured: Baseline, 3- and 6 months (post-intervention)
Dietary intake and diet quality
Typical intake will be assessed using three, non-consecutive (2 weekdays, 1 weekend day), interviewer-administered 24-hour dietary recalls at each measurement time point, conducted telephonically by trained nutritionists and entered into the Nutrient Data System for Research (Minneapolis, MN, v. 2012) From these data, diet quality and its components (total vegetables, whole fruit, whole grains, plant, animal, and seafood proteins, fatty acids, sodium, sugar, and refined grains) will be calculated using the Healthy Eating Index (HEI-2015), a valid and reliable measure of diet quality designed to assess the degree to which an individual's intake conforms to dietary recommendations.
Measured: Baseline, 3- and 6 months (post-intervention)
Food security
USDA 6-item Food Security Questionnaire. Eight additional items from the Current Population Survey Food Security Supplement will allow us to assess food access, expenditures, use of food assistance programs, and other ways of coping with food insecurity.
Measured: Baseline, 3- and 6 months (post-intervention)
Perceived adherence to diabetes self-care behaviors
The Self Care Inventory-Revised (SCI-R) a brief, psychometrically sound measure of patient perceptions of adherence to recommended diabetes self-care behaviors. The SCI-R accommodates various treatment regimens across individuals, while evaluating individuals' perceptions of how well they adhere to their treatment plans.
Measured: Baseline, 3- and 6 months (post-intervention)
Health-related quality of life
The CDC's 4-item Healthy Days Measure asks participants about recent pain, depression, anxiety, sleeplessness, vitality, and the cause, duration, and severity of a current activity limitation an individual may have in their life.
Measured: Baseline, 3- and 6 months (post-intervention)
Height
Height will be measured using a calibrated Seca 213 Portable Stadiometer. All measures will be completed in duplicate, and the average of the two measures will be used.
Measured: Baseline, 3- and 6 months (post-intervention)
Body weight
Baseline, 3- and 6 months (post-intervention)
Measured: Body weight will be measured using a calibrated Cardinal Detecto 758C Weight Indicator scale. All measures will be completed in duplicate, and the average of the two measures will be used.
Body Mass Index
Adult BMI will be categorized using international classifications of BMI (normal weight, 18-24.9 kg/m2; overweight, 25-29.9 kg/m2; obesity, >30 kg/m2).
Measured: Baseline, 3- and 6 months (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start13 Sep 2023
- Primary completion24 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized wait-list controlled pilot study using a convergent mixed methods approach
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- El Rio Community Health Center, Arizona State University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211270
- Sponsor's protocol ID
- 1R01DK132300-01A1
- Acronym
- FRESH
- Status last verified
- Dec 2024
- First submitted
- 8 Jan 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Any publications and presentations that authored by the study team will identify where the data will be available and how to access the data, as well as acknowledge the repository and funding source in any publications and presentations. The study team will explore the use of an NIH-funded repository, which will have policies and procedures in place to provide data access to qualified researchers, fully consistent with NIH data sharing policies and applicable laws and regulations.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food and Resources Expanded to Support Health and Type 2 Diabetes (FRESH-T2D)
- ClinicalTrials.gov ID
- NCT06211270
- Acronym / sponsor ID
- FRESH / 1R01DK132300-01A1
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- El Rio Community Health Center, Arizona State University
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 24 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Jan 2024 (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.
Food insecurity, poor nutrition, and economic disadvantage are critical social determinants of health that contribute to disparities in type 2 diabetes mellitus (T2DM), a serious diet-sensitive chronic disease affecting more than 20% of food insecure adults. There is a demonstrable need for food-focused interventions to address the diet quality of persons with, or at risk of, T2DM. Completion of the pilot study will produce recruitment, retention, adherence, and cost data for a future definitive randomized controlled clinical trial, bringing us closer to the long-term goal of a tested, efficacious model of diabetes care coordinated across Federally Qualified Health Centers and food bank networks.
Detailed description
In 2020, more than 38.5 million (10.5%) U.S. households were without reliable access to sufficient quantities of affordable, nutritious food due to limited money or other resources. Food insecurity, poor nutrition, and economic disadvantage are critical social determinants of health that contribute to disparities in type 2 diabetes mellitus (T2DM), a serious diet-sensitive chronic disease affecting more than 20% of food insecure adults. Coping strategies favor inexpensive, ultra-processed foods that substantially diminish diet quality and are associated with increased incidence and severity of T2DM, including poorer glycemic control and excess body weight. Given that numerous social factors and systems contribute to and perpetuate food insecurity and poor diabetes outcomes, there is a demonstrable need for multilevel (individual, household, community) food-focused interventions to effectively and sustainably address the diet quality of persons with, or at risk of, T2DM. To date, no studies have rigorously tested whether intervention programs explicitly designed to improve both food and nutrition security of low-income persons with T2DM are feasibly delivered by personnel at a Federally Qualified Health Center (FQHC), acceptable to patients seeking care in their medical home, or are capable of producing clinically relevant changes in T2DM endpoints. These are questions will be explored in the proposed randomized wait-list controlled pilot study- Food and Resources Expanded to Support Health and Type 2 Diabetes (FRESH-T2DM)- in which a previously developed food and diabetes self-management education (DSME) intervention (FRESH) will be delivered to 50 adult FQHC patients with T2DM and food insecurity twice monthly, for 6 months. The FRESH intervention consists of bimonthly food provision; a series of recipes that feature FRESH foods; diabetes self-management education (DSME) resources; and four, 30-minute visits with an FQHC Registered Dietitian Nutritionist and Certified Diabetes Educator who will help participants utilize FRESH resources to meet personalized treatment goals. Building upon prior work and existing collaborations with colleagues at El Rio Community Health Center, a Federally Qualified Health Center serving >110,000 underinsured, uninsured patients and the Community Food Bank of Southern Arizona, a regional food bank serving 180,000 Arizonans across 5 counties, the Specific Aims are to: (Specific Aim 1) Assess the feasibility, acceptability, and participant uptake of the FRESH intervention, delivered to 50 food insecure adults with T2DM at their medical home, El Rio Community Health Center, and (Specific Aim 2) Explore changes in blood glucose control, diet quality, food security, diabetes self-care behaviors, and health-related quality of life among participants at 3 and 6 months. Completion of this pilot study -submitted in response to NIDDK PAS-20-160 -will produce data to inform the rationale and design of a future definitive randomized controlled clinical trial, including recruitment, retention, adherence, and cost data. The long-term goal is to produce a tested, efficacious model of coordinated care capable of replication and scaling across other FQHCs and food bank networks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized wait-list controlled pilot study using a convergent mixed methods approach
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: FRESHFRESH-T2D Intervention consisting of bimonthly food, recipes, and diabetes self-management resources + 4 meetings with Registered Dietitian Nutritionists x 6 months duration |
| Wait-Listed Control | Other | Behavioral: FRESHStandard of Care for El Rio Community Health Center persons with type 2 diabetes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult (ages 18+); patient at El Rio Community Health Center; fluent in English or Spanish; physician diagnosis of T2DM; food insecure (based on a "yes" answer to the 2-item Hunger Vital Sign food security screening tool used by El Rio to screen patients); stable housing with access to a kitchen; U.S.-based address and telephone number; willingness to participate in all study activities (Section C.6) for the duration of the study (12 months on study, including 6 months of intervention).
Key exclusion criteria (1 listed)
- diagnosed psychiatric disturbances or mental illness; physical limitations or medical conditions restricting ad libitum food intake (e.g., dysphagia); inability to read and write; no home phone or home address; not able to speak and read English or Spanish.
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 |
|---|---|---|
| FRESHFRESH-T2D Intervention consisting of bimonthly food, recipes, and diabetes self-management resources + 4 meetings with Registered Dietitian Nutritionists x 6 months duration | Behavioural | Intervention, Wait-Listed Control |
Primary outcome
Acceptability Aim 1
Time frame: 6 months (post-intervention)
How participants and those involved in implementing the program react to the intervention, assessed via qualitative in-depth interviews. Satisfaction with foods and resources, suggestions for improvement, perceived usefulness will be explored.
Demand
Time frame: 6 months (post-intervention)
Intervention uptake (relevance of foods/resources/services provided, promoters and barriers to participation in the intervention, degree to which participants report using the intervention resources to influence T2DM, "fit" with daily life, cultural congruence) will be explored in brief surveys and qualitative in-depth interviews.
Implementation
Time frame: 3- and 6 months (post-intervention), and 12 months (follow-up)
The extent, likelihood, and manner in which the intervention is implemented as planned, including participant recruitment and retention rates and ease/burden associated with data collection methods will be estimated from research team logs, and qualitative in-depth interviews. Retention rate will be calculated at study end (12 months).
Practicality
Time frame: Throughout the intervention, and at 6 months (post-intervention)
Adherence(# of boxes received, resources utilized, and RDN/CDE visits completed), will be calculated from research team logs. Costs, burden and benefit the participants and the FQHC will be evaluated using a bottom-up micro-costing approach - for participants, this will include time and resources spent in travel, and services, equipment, and food needed to meet program recommendations; for the FQHC, this includes direct medical and non-medical costs including personnel gross hourly salaries, intervention material costs (in partnership with the Food Bank), and overhead costs related to use of facilities for prevention services will be tracked and analyzed in partnership with FQHC data team members; 5) any adaptation or modifications of the intervention by the FQHC to accommodate patients and organization.
Adaptation
Time frame: 6 months (post-intervention)
Any modifications of the intervention by the FQHC to accommodate patients and organizational requirements and context will be explored through qualitative in-depth interviews with FQHC and Food Bank personnel.
Expansion
Time frame: 6 months (post-intervention)
Potential for sustainability of the program at the FQHC, and expansion of the intervention across other FQHCs, and any positive or negative effects on the organization will be explored through qualitative in-depth interviews with FQHC personnel.
Integration
Time frame: 6 months (post-intervention)
Integration of the FRESH intervention with provider care plans for patients, a systems-level change that would allow the program to be a reimbursable treatment, will be explored through qualitative in-depth interviews with FQHC personnel.
9 secondary outcomes
Demographics and Social Determinants of Health
Time frame: Baseline, 3- and 6 months (post-intervention)
Glycated hemoglobin (HbA1c)
Time frame: Baseline, 3- and 6 months (post-intervention)
Dietary intake and diet quality
Time frame: Baseline, 3- and 6 months (post-intervention)
Food security
Time frame: Baseline, 3- and 6 months (post-intervention)
Perceived adherence to diabetes self-care behaviors
Time frame: Baseline, 3- and 6 months (post-intervention)
Health-related quality of life
Time frame: Baseline, 3- and 6 months (post-intervention)
Height
Time frame: Baseline, 3- and 6 months (post-intervention)
Body weight
Time frame: Body weight will be measured using a calibrated Cardinal Detecto 758C Weight Indicator scale. All measures will be completed in duplicate, and the average of the two measures will be used.
Body Mass Index
Time frame: Baseline, 3- and 6 months (post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: Yes. Any publications and presentations that authored by the study team will identify where the data will be available and how to access the data, as well as acknowledge the repository and funding source in any publications and presentations. The study team will explore the use of an NIH-funded repository, which will have policies and procedures in place to provide data access to qualified researchers, fully consistent with NIH data sharing policies and applicable laws and regulations.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FRESH in people with Diabetes Mellitus, Type 2, run by University of Arizona 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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 17 Dec 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?
This study is still under way. Results are not available in the source record yet.
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?
Acceptability Aim 1 (time frame: 6 months (post-intervention)). 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 17 Dec 2024.