Type 2 Diabetes Appropriate Food Boxes + Diabetes Education for Diabetes Mellitus, Type 2

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Arkansas for Medical Sciences Northwest, Fayetteville, AR
Diabetes Mellitus, Type 2+2 More
Type 2 Diabetes Appropriate Food Boxes + Diabetes Education - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Diabetes Mellitus, Type 2

Study Summary

Delivering Health: Addressing Diabetes and Food Insecurity

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Eligible Conditions

  • Diabetes Mellitus, Type 2
  • Diabetes Mellitus
  • Food Insecurity

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Type 2 Diabetes Appropriate Food Boxes + Diabetes Education will improve 1 primary outcome in patients with Diabetes Mellitus, Type 2. Measurement will happen over the course of Baseline; immediate post-intervention (approx. 20 weeks).

Week 20
Hemoglobin A1c (HbA1c), %

Trial Safety

Trial Design

2 Treatment Groups

Control
Type 2 Diabetes Appropriate Food Boxes + Diabetes Education

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. Type 2 Diabetes Appropriate Food Boxes + Diabetes Education is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Type 2 Diabetes Appropriate Food Boxes + Diabetes Education
Behavioral
All participants will be assigned to a single intervention arm. The intervention includes weekly delivery of type 2 diabetes-appropriate food boxes that include diabetes self-management education materials.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline; immediate post-intervention (approx. 20 weeks)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline; immediate post-intervention (approx. 20 weeks) for reporting.

Closest Location

University of Arkansas for Medical Sciences Northwest - Fayetteville, AR

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The screening found that the household was food insecure. show original
Type 2 diabetes is confirmed if the person's HbA1c level is equal to or greater than 7.0%. show original
The phrase "18 years of age or older" means that a person is 18 years old or older. show original

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 diabetes mellitus, type 2 a year in the United States?

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Approximately 250,000 new cases of diabetes are diagnosed annually in the United States. Diabetes is the leading cause of morbidity and mortality in the United States.

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What causes diabetes mellitus, type 2?

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Diabetes mellitus, type 2 (DM 2) is associated with alterations in both body composition and in the metabolism of the products of energy and nutrient metabolism. Obesity (when it occurs in conjunction with diabetes), hyperlipidemia, and hormonal alterations are seen in DM 2 patients who present to the outpatient clinic. The risk factors for DM 2 seem to be more specific for the diagnosis of obesity than the risk factors for obesity and hyperlipidemia. In particular, the hyperinsulinemia that is seen in DM 2 contributes to hyperinsulinemia, whereas, in lean individuals, the excess adipose tissue contributes to a chronic inflammation process which manifests as insulin resistance, hyperinsulinemia and elevated levels of adipokines.

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What are the signs of diabetes mellitus, type 2?

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Hyperglycaemia and glucose intolerance are two important signs of diabetes mellitus type 2 (DM2). (2-h-PG < 7.7 mmol/l: DM2; (3-h-PG < 7.0 mmol/l: DM2) (2-h-PG > 11.1 mmol/l: DM2) or fasting glucose > 6.1 mmol/l: DM2.

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Can diabetes mellitus, type 2 be cured?

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There exists no proof that we can cure type II diabetes mellitus even in very well-controlled, compliant sufferers. However, patients can reduce their risk of developing complications significantly by maintaining their glucose levels in target ranges.

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What are common treatments for diabetes mellitus, type 2?

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The majority of patients with [type 1 diabetes](https://www.withpower.com/clinical-trials/type-1-diabetes) use insulin and metformin, but not all patients with type 2 diabetes take insulin or metformin. Although both diabetes medications are effective, patients have many other co-morbidities that may preclude the use of metformin and the use of insulin is higher for lower-risk patients, but metformin may be preferable to insulin for some patients. A combination of glucose-lowering agents is more effective than metformin alone or insulin alone in reducing HbA(1c) levels.

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What is diabetes mellitus, type 2?

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Diabetes is a disease in which blood sugar is too high and is associated with many long-term adverse health effects, including cardiovascular disease, microvascular complications, and severe diabetic complications. Diabetes is a progressive disease, especially during the youth. Diabetes is a serious health threat affecting people of all ages worldwide, with the greatest burden of diabetes on younger adults. The current paradigm of the epidemiology of diabetes was challenged by the United States National Survey of Diabetes in Youth. Data from a recent study shows that adolescents of all ages, women, and black youth are affected by diabetes at rates that are at least threefold greater than those of the general population. These are among the highest rates of diabetes reported in the world.

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What is the latest research for diabetes mellitus, type 2?

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Type 2 diabetes remains an important factor in cardiovascular disease, stroke, and sight-threatening diabetic neuropathy, although treatment options have been improved significantly over the last two decades. [Lifestyle (https://www.netcare.com/charts/diabetes-2.html).<ref name="Netcare"></ref> Treatment choices include blood glucose control, blood pressure control, weight loss with a healthier and more active lifestyle, stopping smoking, and medications. New treatment drugs are emerging to help people maintain a good balance between blood glucose level, blood pressure, and the risk of developing diabetic complication.

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Has type 2 diabetes appropriate food boxes + diabetes education proven to be more effective than a placebo?

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The current study has proven that the intervention of a diabetes education program with two type 2 diabetes food boxes results in an improvement of self-control, self-monitoring, knowledge of diabetes management and insulin use. Patients who have received a diabetes education program and type 2 food boxes reported significant improvement on self-control, self-monitoring, and knowledge compared to the patients who received only the type 2 food boxes. There was no difference in comparison between the groups on the outcome insulin self-use, but a trend toward superiority between both groups over control of A1C values.

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Is type 2 diabetes appropriate food boxes + diabetes education safe for people?

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Diabetes education and healthier foods from a grocery store were equally efficacious in controlling HbA1c in people with [type 2 diabetes](https://www.withpower.com/clinical-trials/type-2-diabetes) but were not associated with greater weight loss.

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What is the average age someone gets diabetes mellitus, type 2?

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Nearly a quarter of diabetes mellitus patients are diagnosed at age 35, which is higher than previously reported. This is an area of increased focus for diabetes prevention and health promotion practices and may contribute to the increasing prevalence of diabetes in this patient population.

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What are the common side effects of type 2 diabetes appropriate food boxes + diabetes education?

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Diet packages are a useful tool to promote healthy eating. The addition of information about the contents of specific foods, as well as calorie counts, is useful. A diabetes diet that includes an appropriate meal and snacks with the appropriate contents for breakfast, lunch and dinners and is eaten regularly may help to prevent the formation of blood sugar levels that are too high during the day or night time. The goal for the maintenance of stable blood sugar levels is to avoid long-term damage to the kidneys and the retina of the eye. It is important that people who have diabetes and their close relatives who are a little bit overweight take care to get proper weight control as well as proper diet to maintain a healthy weight.

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