Clinical trial NCT06211270: Food and Resources Expanded to Support Health and Type 2 Diabetes
Official title: Food and Resources Expanded to Support Health and Type 2 Diabetes (FRESH-T2D)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: El Rio Community Health Center
name: Arizona State University
First posted: 2024-01-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized wait-list controlled pilot study using a convergent mixed methods approach
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acceptability Aim 1
timeFrame: 6 months (post-intervention)
measure: Demand
timeFrame: 6 months (post-intervention)
measure: Implementation
timeFrame: 3- and 6 months (post-intervention), and 12 months (follow-up)
measure: Practicality
timeFrame: Throughout the intervention, and at 6 months (post-intervention)
measure: Adaptation
timeFrame: 6 months (post-intervention)
measure: Expansion
timeFrame: 6 months (post-intervention)
measure: Integration
timeFrame: 6 months (post-intervention)
Secondary outcomes:
measure: Demographics and Social Determinants of Health
timeFrame: Baseline, 3- and 6 months (post-intervention)
measure: Glycated hemoglobin (HbA1c)
timeFrame: Baseline, 3- and 6 months (post-intervention)
measure: Dietary intake and diet quality
timeFrame: Baseline, 3- and 6 months (post-intervention)
measure: Food security
timeFrame: Baseline, 3- and 6 months (post-intervention)
measure: Perceived adherence to diabetes self-care behaviors
timeFrame: Baseline, 3- and 6 months (post-intervention)
measure: Health-related quality of life
timeFrame: Baseline, 3- and 6 months (post-intervention)
measure: Height
timeFrame: Baseline, 3- and 6 months (post-intervention)
measure: Body weight
timeFrame: 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.
measure: Body Mass Index
timeFrame: Baseline, 3- and 6 months (post-intervention)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: El Rio Community Health Center
state: Arizona
Study officials:
References: