The purpose of this study is to investigate the effect of providing healthy foods and nutrition education on participants' body weight, blood pressure, and average blood sugar level. The healthy food offerings tested in this study will help determine which option is best to improve health outcomes among Cleveland Clinic Akron General patients with chronic conditions. Findings from this study could guide doctors in deciding on appropriate nutrition and dietitian services for Cleveland Clinic patients.
Participants will receive healthy food items for 15 weeks and nutrition counseling and education to support chronic disease management at no cost. The healthy food items will consist of either medically-tailored pre-prepared meals, or a weekly produce box with recipes depending on the study arm. Participants must complete a baseline study visit, one nutritional counseling session via phone, 2 to 4 nutrition education videos, and a 16-week post-intervention study visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
70
Medically tailored meals delivered to patients' homes for 15 weeks AND one medical nutrition therapy session with a dietician + viewership of 2 to 4 nutrition education videos.
Weekly produce box and access to recipes via internet for 15 weeks AND one medical nutrition therapy session with a dietician + viewership of 2 to 4 nutrition education videos.
Cleveland Clinic Akron General
Akron, Ohio, United States
Change in participants' body weight
Percent weight loss
Time frame: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Pre-type 2 diabetes mellitus: Change in number of medications
Absolute change in number of medications
Time frame: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Pre-type 2 diabetes mellitus: Change in medication dosage
Percent change in medication dosage
Time frame: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Pre-type 2 diabetes mellitus: Change in HbA1c
Absolute change in HbA1c
Time frame: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Type 2 diabetes mellitus: Change in number of medications
Absolute change in number of medications
Time frame: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Type 2 diabetes mellitus: Change in medication dosage
Percent change in medication dosage
Time frame: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Type 2 diabetes mellitus: Change in HbA1c
Absolute change in HbA1c
Time frame: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Hypertension: Change in number of medications
Absolute change in number of medications
Time frame: Baseline visit (W1) to 16 week visit
Hypertension: Change in medication dosage
Percent change in medication dosage
Time frame: Baseline visit (W1) to 16 week visit
Receipt of healthy food items: The Hunger Vital Sign scale
Values on the scale are: often true, sometimes true, and never true. A positive response to either or both of the first two values (often true, sometimes true) identifies households as being at risk for food insecurity
Time frame: Baseline visit (W1) to week 16 visit
Receipt of healthy food items: Eating at America's Table scale
Each reported frequency is expressed as a daily average ranging from 0 to 5. The estimate of the daily number of Pyramid/MyPyramid servings is calculated as average daily frequency x the number of Pyramid/MyPyramid servings for the portion size, summed across all food groups. A higher score for fruits and vegetables indicates a better outcome.
Time frame: Baseline visit (W1) to week 16 visit
Receipt of healthy food items: Patient Health Questionnaire-8 Depression Scale
Eight items, each of which is scored 0 to 3, providing a 0 to 24 severity score. Overall score is the sum of the 8 items. A score of 10 or greater is considered major depression, 20 or more is severe major depression.
Time frame: Baseline visit (W1) to week 16 visit
Nutrition Education: Healthy Eating and Weight Self-Efficacy Scale
Values on the scale are: Strongly disagree, disagree, neutral, agree, and strongly agree. Responses of agree and strongly agree indicate a better outcome.
Time frame: Baseline visit (W1) to 16-week visit
Nutrition Education: Self-Efficacy for Managing Chronic Diseases Scale
Six items, each of which is scored 0 to 10. Overall score is the mean of the 6 items. A higher score indicates a better outcome.
Time frame: Baseline visit (W1) to 16-week visit
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