CLINICAL TRIAL

Medically-tailored meals for Chronic Disease

Recruiting · 18+ · All Sexes · Akron, OH

Food as Medicine: A Quasi-Randomized Control Trial of Healthy Foods for Chronic Disease Management

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About the trial for Chronic Disease

Eligible Conditions
Chronic Disease · Prediabetic State · Hypertension · Diabetes Mellitus · Pre-diabetes · Type 2 Diabetes Mellitus · Obesity

Treatment Groups

This trial involves 2 different treatments. Medically-tailored Meals is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
Medically-tailored meals
OTHER
Experimental Group 2
Produce box and recipes
OTHER

Eligibility

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
BMI equal to or greater than 30kg/m2 indicates obesity. show original
Hypertension
I have not participated in nutrition counseling at the University of Akron Nutrition Center within the past 6 months. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Medically-tailored meals will improve 1 primary outcome and 13 secondary outcomes in patients with Chronic Disease. Measurement will happen over the course of Baseline visit (W1) to 16 week visit.

Hypertension: Change in medication dosage
BASELINE VISIT (W1) TO 16 WEEK VISIT
Percent change in medication dosage
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 number of medications
BASELINE VISIT (W1) TO 16 WEEK VISIT
Absolute change in number of medications
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.
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.
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.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get chronic disease a year in the United States?

Around 18.9 million people in the United States are diagnosed with at least one chronic disease. This represents 13.3% of US adults. The leading chronic diseases include diabetes, myocardial infarction, chronic respiratory diseases, cirrhosis, and COPD. This information can inform health policies and programs aiming to control the burden of chronic health conditions.

Anonymous Patient Answer

Can chronic disease be cured?

Although the question of whether chronic disease can be cured remains controversial. There might be benefits if the illness can be stopped, even if a cure is impossible.

Anonymous Patient Answer

What is chronic disease?

People with chronic disease are very real. They are often misunderstood and are often very ill. People with chronic disease are also an important aspect of a family's and an individual's emotional health. They are often the ones who are most negatively affected, most often by health inequalities. \n\nThe main aim of the programme is to empower, educate and empower adults and children living with long term debilitating diseases such as heart disease, diabetes, cancer and mental illness.\n\nChildren with long-term debilitating diseases such as polio, sickle cell and cerebral palsy are also encouraged to participate.

Anonymous Patient Answer

What are common treatments for chronic disease?

In this survey, no common treatments could be identified for chronic disease. Despite the diversity of the clinical picture in patients with chronic diseases such as COPD, asthma, diabetes and ischaemic heart disease, no single intervention was shown to be optimal. This raises the intriguing possibility that other mechanisms of disease progression are at hand.

Anonymous Patient Answer

What causes chronic disease?

Identifying and treating any modifiable factors will improve health. If a risk factor for a chronic disease is suspected in a newly diagnosed individual, ask the subject about their habits prior to their diagnosis. A history of the risk factor, and how often it is used, may indicate how significant the risk is, and may also reflect how difficult it is to change. The individual should also be informed of the possible benefits of changing their behavior (for example by losing a lot of weight or quitting smoking). summary: This article summarizes the factors relating to obesity, hypertension, diabetes, and cancer.

Anonymous Patient Answer

What are the signs of chronic disease?

The signs and symptoms of chronic diseases include pain, swelling, warmth, itchiness, fatigue, tiredness, memory loss, headache and difficulty walking. Many chronic diseases are not easily discernible or can be mistaken for other health conditions; hence, the diagnosis of chronic diseases is based on patient's signs and symptoms.

Anonymous Patient Answer

Have there been other clinical trials involving produce box and recipes?

In spite of a clear and growing interest in foods associated with breast cancer, current randomized controlled trials are of low quality, with reporting that does not meet reporting standards for clinical trials.

Anonymous Patient Answer

How serious can chronic disease be?

Serious chronic disease is not a very serious problem or even a rarity in the United Kingdom, as the vast majority of diseases have the potential for serious problems related to their progression in the long term. Despite having serious problems with chronic disease, people in general are more positive about their lives (and life expectancy) than would be expected from having such severe illnesses. For example, on average people have a life expectancy in the U.K. of a little over 70 years but with chronic diseases such as heart disease or cancer, the life expectancy is in theory far shorter. On average, the United Kingdom has a life expectancy of about 72.9 years at birth (the world average is 60.3).

Anonymous Patient Answer

What is produce box and recipes?

The produce box and recipes are valuable to our residents. They are an effective resource that are well used and well liked by staff. To improve the produce box and recipes, more resources need to be made available such as the resources to produce more boxes, and resources to more adequately promote and sell produce.

Anonymous Patient Answer

What is the latest research for chronic disease?

[Recent research on chronic disease has resulted in many treatment options, which is good news] for those who use them, [though] chronic disease prevention and cure continue to be a goal for scientists and [the health care] providers. [The NIH has] created the Chronic Disease Network to help promote collaborative study within the agency. Visit [www.nih.gov/chd/index.cfm/index.cfm?fcnID=10&dbID=1 (Chd-CGI, 2005)].

Anonymous Patient Answer

Does produce box and recipes improve quality of life for those with chronic disease?

Findings from a recent study suggest that the use of a recipe to promote self-management of their chronic condition improved overall HRQoL in a group of people with chronic and complex care needs, and reduced depressive symptoms.

Anonymous Patient Answer

Is produce box and recipes typically used in combination with any other treatments?

We did not find any significant differences between the use of specific produce boxes and recipes. Thus we cannot recommend the use of special produce boxes or recipes while being treated. However, this does not mean that all produce boxes or recipes will trigger adverse effects.

Anonymous Patient Answer
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