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Principal Investigator: Melanie Daniela Hingle
Organization: UNIVERSITY OF ARIZONA
Fiscal Year: 2024
Award: $257,243
Funding agency: National Institute of Diabetes and Digestive and Kidney Diseases
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 our
knowledge, 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 we will explore in our proposed
randomized wait-list controlled pilot study— Food and Resources Expanded to Support Health and Type
2 Diabetes (FRESH-T2DM)— in which our 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. We will build upon our 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 to: (Specific Aim 1) Assess the feasibility, acceptability,
and participant uptake of our 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 our 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. Our 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.
Terms: <21+ years old><Address><Adherence><Adult><Adult Human><Adult-Onset Diabetes Mellitus><Affect><American><Arizona><Behavior><Belief><Blood Glucose><Blood Sugar><Body Weight><COVID crisis><COVID epidemic><COVID pandemic><COVID-19 crisis><COVID-19 epidemic><COVID-19 era><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health crisis><COVID-19 pandemic><COVID-19 period><COVID-19 public health crisis><COVID-19 years><Carbohydrates><Certification><Chronic><Chronic Disease><Chronic Illness><Collaborations><Communities><Community Health Centers><Coping Skills><County><Custom><Data><Diabetes Mellitus><Diet><Dietitian><Disease Management><Disorder Management><Disparities><Disparity><Drugs><Economically Deprived><Education><Education for Intervention><Educational Intervention><Educational aspects><Ensure><Evaluation><Federally Qualified Health Center><Fiber><Food><Food Assistance Programs><Food Packaging><Future><Glycohemoglobin A><Glycosylated hemoglobin A><Goals><Hb A1><Hb A1a+b><Hb A1c><HbA1><HbA1c><Health><Health Resources><Healthy Eating><Hemoglobin A(1)><Home><Household><Human Resources><Incidence><Individual><Instruction Intervention><Intake><Intervention><Intervention Strategies><Ketosis-Resistant Diabetes Mellitus><Life Style><Lifestyle><Low Income Population><Low income><Low income group><Manpower><Maturity-Onset Diabetes Mellitus><Medical><Medication><Methods><Modeling><Monitor><Morbidity><Morbidity - disease rate><NIDDK><NIDDM><National Institute of Diabetes and Digestive and Kidney Diseases><Neighborhood Health Center><Non-Insulin Dependent Diabetes><Non-Insulin-Dependent Diabetes Mellitus><Noninsulin Dependent Diabetes><Noninsulin Dependent Diabetes Mellitus><Nutrient><Nutritional><Nutritionist><Outcome><Participant><Patients><Persons><Pharmaceutical Preparations><Pilot Projects><Problem Solving><Process><Public Health><Randomized><Randomized Controlled Clinical Trials><Recipe><Recommendation><Research><Research Resources><Resources><Risk><Risk Reduction><SARS-CoV-2 epidemic><SARS-CoV-2 global health crisis><SARS-CoV-2 global pandemic><SARS-CoV-2 pandemic><SARS-coronavirus-2 epidemic><SARS-coronavirus-2 pandemic><Security><Self Care><Series><Severe Acute Respiratory Syndrome CoV 2 epidemic><Severe Acute Respiratory Syndrome CoV 2 pandemic><Severe acute respiratory syndrome coronavirus 2 epidemic><Severe acute respiratory syndrome coronavirus 2 pandemic><Severities><Slow-Onset Diabetes Mellitus><Stable Diabetes Mellitus><System><T2 DM><T2D><T2DM><Testing><Training Intervention><Type 2 Diabetes Mellitus><Type 2 diabetes><Type II Diabetes Mellitus><Type II diabetes><Underinsured><Uninsured><Visit><Waiting Lists><Work><acceptability and feasibility><adult onset diabetes><adulthood><blood glucose regulation><care coordination><care seeking><chronic disorder><clinical relevance><clinically relevant><coordinating care><coping><coping strategy><coronavirus disease 2019 crisis><coronavirus disease 2019 epidemic><coronavirus disease 2019 global health crisis><coronavirus disease 2019 global pandemic><coronavirus disease 2019 health crisis><coronavirus disease 2019 pandemic><coronavirus disease 2019 public health crisis><coronavirus disease crisis><coronavirus disease epidemic><coronavirus disease pandemic><coronavirus disease-19 global pandemic><coronavirus disease-19 pandemic><cost><customs><design><designing><diabetes><diabetes control><diabetes educator><diabetes mellitus control><diabetes self-care><diabetes self-management><dietary><diets><drug/agent><economic disparity><economically disadvantaged><education resources><educational resources><evidence base><food insecurity><food resource><food security><fruits and vegetables><glucose control><glucose homeostasis><glucose regulation><glycemic control><health related quality of life><hemoglobin A1c><homes><improved><instructional intervention><intervention program><interventional strategy><ketosis resistant diabetes><low income individual><low income people><maturity onset diabetes><mortality><nutrition><nutritious><participant engagement><patient centered><patient engagement><patient oriented><personal care><personalization of treatment><personalized medicine><personalized therapy><personalized treatment><personnel><pilot study><prevent><preventing><randomisation><randomization><randomized control clinical trial><randomly assigned><recruit><reduce risk><reduce risks><reduce that risk><reduce the risk><reduce these risks><reduces risk><reduces the risk><reducing risk><reducing the risk><response><retention rate><retention strategy><risk-reducing><severe acute respiratory syndrome coronavirus 2 global health crisis><severe acute respiratory syndrome coronavirus 2 global pandemic><social factors><social health determinants><type 2 DM><type II DM><type two diabetes><uptake><waitlist>