Food and Resources Expanded to Support Health and Type 2 Diabetes

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.

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.

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).

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.

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.

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 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.

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.

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).

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.

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.

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.

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.

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)

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).