Rationale and design of the linking education, produce provision, and community referrals to improve diabetes care (LINK) study.

BACKGROUND: Individuals with type 2 diabetes (T2D) experiencing food insecurity may have other non-medical, health-related social needs (e.g., transportation, housing instability) that decrease their ability to attain T2D control and impact other health outcomes. METHODS: A pragmatic randomized controlled trial (pRCT) to test the effect of produce provision, diabetes and culinary skills training and education, and social needs screening, navigation, and resolution, on hemoglobin A1c (A1c) levels in individuals with T2D (A1c ≥7.5%) experiencing food insecurity; a cost-effectiveness evaluation of the interventions that comprise the pRCT; and a process evaluation to understand the contextual factors that impact the uptake, effectiveness, and sustainability of the interventions. SETTING: Ambulatory care clinics (e.g., family medicine, general internal medicine, endocrinology) affiliated with an academic medical center in an urban environment in the Midwest. DESIGN: 2 × 2 factorial design. INTERVENTIONS: Cooking Matters for Diabetes is a 6-week diabetes and culinary education intervention. The Health Impact Ohio Central Ohio Pathways Hub intervention is a community health worker model designed to evaluate and address participants' social needs. All participants will receive referral to the Mid-Ohio Farmacy to provide weekly access to fresh produce. OUTCOMES: Primary outcome of the pRCT is change in A1c at 3 months; secondary outcomes include A1c at 6 months, and diabetes self-efficacy, food insecurity, and diet quality at 3 and 6 months. DISCUSSION: Food insecurity, unmet social needs, diabetes education and self-efficacy are critical issues that must be addressed to improve T2D treatment, care, and health equity. CLINICALTRIALS: gov: NCT05472441.

Feasibility of Cooking Matters for Diabetes: A 6-week Randomized, Controlled Cooking and Diabetes Self-Management Education Intervention.

BACKGROUND: Diabetes self-management education and support is the cornerstone of diabetes care, yet <10% of adults with diabetes manage their condition successfully. Feasible interventions are needed urgently. OBJECTIVE: Our aim was to assess the feasibility of a cooking intervention with food provision and diabetes self-management education and support. DESIGN: This was a waitlist-controlled, randomized trial. PARTICIPANTS/SETTING: Thirteen adults with type 1 or type 2 diabetes who participated in Cooking Matters for Diabetes (CMFD) participated in 2 focus groups. INTERVENTION: CMFD was adapted from Cooking Matters and the American Diabetes Association's diabetes self-management education and support intervention into a 6-week program with weekly lesson-aligned food provisions. MAIN OUTCOME MEASURES: Feasibility was evaluated quantitatively and qualitatively along the following 5 dimensions: demand, acceptability, implementation, practicality, and limited efficacy. STATISTICAL ANALYSIS: Two coders extracted focus group themes with 100% agreement after iterative analysis, resulting in consensus. Administrative data were analyzed via descriptive statistics. RESULTS: Mean (SD) age of focus group participants was 57 (14) years; 85% identified as female; 39% identified as White; 46% identified as Black; and income ranged from <$5,000 per year (15%) to $100,000 or more per year (15%). Mean (SD) baseline hemoglobin A1c was 8.6% (1.2%). Mean attendance in CMFD was 5 of 6 classes (83%) among all participants. Demand was high based on attendance and reported intervention utilization and was highest among food insecure participants, who were more likely to report using the food provisions and recipes. Acceptability was also high; focus groups revealed the quality of instructors and interaction with peers as key intervention strengths. Participant ideas for implementation refinement included simplifying recipes, lengthening class sessions, and offering more food provision choices. Perceived effects of the intervention included lower hemoglobin A1c and body weight and improvements to health-related quality of life. CONCLUSIONS: The CMFD intervention was feasible according to the measured principles of demand, acceptability, implementation, practicality, and limited efficacy.

Outcomes of Cooking Matters for Diabetes: A 6-week Randomized, Controlled Cooking and Diabetes Self-Management Education Intervention.

BACKGROUND: Diabetes self-management education and support is the cornerstone of diabetes care, yet only 1 in 2 adults with diabetes attain hemoglobin A1c (HbA1c) targets. Food insecurity makes diabetes management and HbA1c control more difficult. OBJECTIVE: Our aim was to test whether a cooking intervention with food provision and diabetes self-management education and support improves HbA1c and diabetes management. DESIGN: This was a waitlist-controlled, randomized trial. PARTICIPANTS/SETTING: Participants were 48 adults with type 1 or type 2 diabetes. INTERVENTION: Cooking Matters for Diabetes was adapted from Cooking Matters and the American Diabetes Association diabetes self-management education and support intervention into a 6-week program with weekly food provision (4 servings). MAIN OUTCOME MEASURES: Surveys (ie, Summary of Diabetes Self-Care Activities; Medical Outcomes Study Short Form Health Survey, version 1; Diet History Questionnaire III; 10-item US Adult Food Security Survey Module; and Stanford Diabetes Self-Efficacy Scale) were administered and HbA1c was measured at baseline, post intervention, and 3-month follow-up. STATISTICAL ANALYSIS: Mixed-effects linear regression models controlling for sex and study wave were used. RESULTS: Mean (SD) age of participants was 57 (12) years; 65% identified as female, 52% identified as White, 40% identified as Black, and 19 (40%) were food insecure at baseline. Intervention participants improved Summary of Diabetes Self-Care Activities general diet score (0 to 7 scale) immediately post intervention (+1.51; P = .015) and 3 months post intervention (+1.23; P = .05), and improved Medical Outcomes Study Short Form Health Survey, version 1, mental component score (+6.7 points; P = .025) compared with controls. Healthy Eating Index 2015 total vegetable component score improved at 3 months (+0.917; P = .023) compared with controls. At baseline, food insecure participants had lower self-efficacy (5.6 vs 6.9 Stanford Diabetes Self-Efficacy Scale; P = .002) and higher HbA1c (+0.77; P = .025), and demonstrated greater improvements in both post intervention (+1.2 vs +0.4 Stanford Diabetes Self-Efficacy Scale score; P = .002, and -0.12 vs +0.39 HbA1c; P = .25) compared with food secure participants. CONCLUSIONS: Cooking Matters for Diabetes may be an effective method of improving diet-related self-care and health-related quality of life, especially among food insecure patients, and should be tested in larger randomized controlled trials.