Hypertension, Obesity, Pre-diabetes, Type 2 Diabetes
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERMedically-tailored meals
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.
OTHERProduce box and recipes
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.
Sponsors
The Cleveland Clinic
The University of Akron
Cleveland Clinic Akron General
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
A quasi-randomized control trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults 18 years of age or older who are patients at Akron General Center for Family Medicine * Have body mass index (BMI) equal to or greater that 30kg/m2 AND * Have at least one of the following diagnoses determined based on patients' problem list in the electronic medical record (EMR) and the international classification of diseases, 10th revision (ICD-10) codes: 1. Pre-type 2 diabetes mellitus 2. Type 2 diabetes mellitus 3. Hypertension * Have NOT participated in nutrition counseling at the University of Akron Nutrition Center within the past 6 months
Exclusion criteria
* Food allergies * Pregnant * No access to internet * Need English language interpretation * Currently participating in a structured weight loss program or using weight loss medications * Any condition that, in the Investigator's judgement, interferes with the ability to adhere to study requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in participants' body weight | From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline | Percent weight loss |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pre-type 2 diabetes mellitus: Change in medication dosage | From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline | Percent change in medication dosage |
| Pre-type 2 diabetes mellitus: Change in HbA1c | From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline | Absolute change in HbA1c |
| Type 2 diabetes mellitus: Change in number of medications | From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline | Absolute change in number of medications |
| Type 2 diabetes mellitus: Change in medication dosage | From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline | Percent change in medication dosage |
| Type 2 diabetes mellitus: Change in HbA1c | From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline | Absolute change in HbA1c |
| Hypertension: Change in number of medications | Baseline visit (W1) to 16 week visit | Absolute change in number of medications |
| Pre-type 2 diabetes mellitus: Change in number of medications | From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline | Absolute change in number of medications |
| Receipt of healthy food items: The Hunger Vital Sign scale | Baseline visit (W1) to week 16 visit | 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 |
| Receipt of healthy food items: Eating at America's Table scale | Baseline visit (W1) to week 16 visit | 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. |
| Receipt of healthy food items: Patient Health Questionnaire-8 Depression Scale | Baseline visit (W1) to week 16 visit | 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. |
| Nutrition Education: Healthy Eating and Weight Self-Efficacy Scale | Baseline visit (W1) to 16-week visit | Values on the scale are: Strongly disagree, disagree, neutral, agree, and strongly agree. Responses of agree and strongly agree indicate a better outcome. |
| Nutrition Education: Self-Efficacy for Managing Chronic Diseases Scale | Baseline visit (W1) to 16-week visit | 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. |
| Hypertension: Change in medication dosage | Baseline visit (W1) to 16 week visit | Percent change in medication dosage |
Countries
United States
Outcome results
None listed