Food and Resources Expanded to Support Health and Type 2 Diabetes (FRESH)

December 12, 2024 updated by: University of Arizona

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85701
        • El Rio Community Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
FRESH-T2D Intervention consisting of bimonthly food, recipes, and diabetes self-management resources + 4 meetings with Registered Dietitian Nutritionists x 6 months duration
Behavioral: FRESH
FRESH-T2D Intervention consisting of bimonthly food, recipes, and diabetes self-management resources + 4 meetings with Registered Dietitian Nutritionists x 6 months duration
Other: Wait-Listed Control
Standard of Care for El Rio Community Health Center persons with type 2 diabetes.
Behavioral: FRESH
FRESH-T2D Intervention consisting of bimonthly food, recipes, and diabetes self-management resources + 4 meetings with Registered Dietitian Nutritionists x 6 months duration

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months (post-intervention)
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.
6 months (post-intervention)
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).
3- and 6 months (post-intervention), and 12 months (follow-up)
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.
Throughout the intervention, and at 6 months (post-intervention)
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.
6 months (post-intervention)
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.
6 months (post-intervention)
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.
6 months (post-intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Demographics and Social Determinants of Health
Time Frame: Baseline, 3- and 6 months (post-intervention)
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.
Baseline, 3- and 6 months (post-intervention)
Glycated hemoglobin (HbA1c)
Time Frame: Baseline, 3- and 6 months (post-intervention)
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).
Baseline, 3- and 6 months (post-intervention)
Dietary intake and diet quality
Time Frame: Baseline, 3- and 6 months (post-intervention)
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.
Baseline, 3- and 6 months (post-intervention)
Food security
Time Frame: Baseline, 3- and 6 months (post-intervention)
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.
Baseline, 3- and 6 months (post-intervention)
Perceived adherence to diabetes self-care behaviors
Time Frame: Baseline, 3- and 6 months (post-intervention)
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.
Baseline, 3- and 6 months (post-intervention)
Health-related quality of life
Time Frame: Baseline, 3- and 6 months (post-intervention)
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.
Baseline, 3- and 6 months (post-intervention)
Height
Time Frame: Baseline, 3- and 6 months (post-intervention)
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.
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.
Baseline, 3- and 6 months (post-intervention)
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)
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).
Baseline, 3- and 6 months (post-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Arizona

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Arizona State University
El Rio Community Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 13, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 24, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1R01DK132300-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

After the study has concluded in January 2026.

IPD Sharing Access Criteria

A resource sharing plan is not required by the NIH for applications requesting <$500,000 in direct costs for any budget period, nor does the NIDDK require a resource sharing plan under the PAS-20-160 funding mechanism. However, in support of research transparency, rigor, and reproducibility, the study investigators will support requests for access to pilot and feasibility data from qualified scientists for specific analyses.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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