Food and Resources Expanded to Support Health and Type 2 Diabetes

NCT06211270 | Enrolling By Invitation

• 1 other identifier: 1R01DK132300-01A1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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).

  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.

  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.

  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.

  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.

  6 months (post-intervention)

Secondary Outcomes (9)

• Demographics and Social Determinants of Health

  Baseline, 3- and 6 months (post-intervention)

• Glycated hemoglobin (HbA1c)

  Baseline, 3- and 6 months (post-intervention)

• Dietary intake and diet quality

  Baseline, 3- and 6 months (post-intervention)

• Food security

  Baseline, 3- and 6 months (post-intervention)

• Perceived adherence to diabetes self-care behaviors

  Baseline, 3- and 6 months (post-intervention)

Study Arms (2)

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

Behavioral: FRESH

Wait-Listed Control

OTHER

Standard of Care for El Rio Community Health Center persons with type 2 diabetes.

Behavioral: FRESH

Interventions

FRESH BEHAVIORAL

FRESH-T2D Intervention consisting of bimonthly food, recipes, and diabetes self-management resources + 4 meetings with Registered Dietitian Nutritionists x 6 months duration

Intervention; Wait-Listed Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead
• El Rio Community Health Center: collaborator
• Arizona State University: collaborator

Study Sites (1)

El Rio Community Health Center

Tucson, Arizona, 85701, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data collectors are blinded to participant's study arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized wait-list controlled pilot study using a convergent mixed methods approach

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: September 13, 2023
• Primary Completion: October 24, 2025
• Study Completion: December 31, 2025
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After the study has concluded in January 2026.
• 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.

Locations

US (1)