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Sponsor: University of Arkansas
Conditions: Diabetes Mellitus, Type 2, Diet, Healthy
Interventions: Healthy Food Delivery Intervention, CDCES Consultation Only
Countries: United States
The goal of this randomized controlled trial was to determine the effectiveness of a Healthy Food Delivery Intervention (HFDI) on the outcomes of rural food insecure patients with type 2 diabetes mellitus (T2DM). Our specific aims were to: 1. Compare the effectiveness of the HFDI and CDCES Consultation Only to improve diabetes-related outcomes among rural food insecure patients with T2DM. Hypotheses: Compared with CDCES Consultation Only, patients receiving the HFDI will demonstrate improved: H1- glycemic control as measured by HbA1c; H2- cardio-metabolic risk factors: body mass index (BMI), blood pressure, total cholesterol, high-density lipoproteins (HDL), low-density lipoproteins (LDL), triglycerides, blood glucose; H3- diabetes management self-efficacy; H4- diabetes-related distress. 2. Compare the effectiveness of the HFDI and CDCES Consultation Only to improve diet quality among rural food insecure patients with T2DM. Hypotheses: Compared with CDCES Consultation Only, patients receiving the HFDI will demonstrate improved: H1- Healthy Eating Index 2015 (HEI-2015) scores; H2- fruit and vegetable consumption as measured by Veggie Meter scores. 3. Compare cost-effectiveness to understand HFDI costs in relationship to outcomes in relation to CDCES Consultation Only. Hypothesis: The HFDI will be cost-effective based on traditional cost per additional quality-adjusted life year gained.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Inclusion Criteria: * 18 years of age or older * HbA1c equal to or greater than 6.5 * Speak English or Spanish Exclusion Criteria: * conditions making it unlikely the participant will be able to follow the protocol, such as terminal illness, severe mental illness, severely impaired vision or hearing, eating disorder, or plans to move out of the geographic region * Pregnant * Only one adult with T2DM per household will be enrolled
- Batesville, Arkansas, United States
- Corning, Arkansas, United States
- Eureka Springs, Arkansas, United States
- Fayetteville, Arkansas, United States
- Fayetteville, Arkansas, United States
- Fort Smith, Arkansas, United States
- Harrison, Arkansas, United States
- Helena, Arkansas, United States
- Jonesboro, Arkansas, United States
- Magnolia, Arkansas, United States
- Marianna, Arkansas, United States
- Marshall, Arkansas, United States
- Pocahontas, Arkansas, United States