Looking for participants to trial the impact of tailored meals and nutrition education for uncontrolled diabetes

Looking for participants to trial the impact of tailored meals and nutrition education for uncontrolled diabetes

Posted by Medivizor on Aug 23, 2020 in Diabetes mellitus |

In a nutshell

This study is evaluating the effect of medically tailored meals and nutrition education via tele-health for patients with uncontrolled type 2 diabetes (T2D). The outcomes include changes in blood glucose control, body weight, and confidence in self-managing care. This study is taking place in Philadelphia, Pennsylvania, United States.

The details

Lifestyle changes including diet and exercise are an important aspect of diabetes management. However, many patients with T2D have difficulty making these changes and controlling blood glucose levels. Surveys have identified nutrition education and access to diabetes-friendly meals as supports which may aid patients with T2D in making these changes.

This study will compare medically tailored meals (MTM) alone or MTM with remote nutrition education. The outcomes include changes in glycated hemoglobin (HbA1c, a measure of long-term glucose control), quality of life, and cost-effectiveness.

Who are they looking for?

This study is looking for 600 patients with T2D. To participate, patients must have blood glucose above the target level (HbA1c over 8%). They must speak English and have access to a device that can be used for tele-health visits (phone, tablet, or computer with Internet access).

Patients who have type 1 diabetes are not eligible. Patients who are pregnant or nursing are not eligible. Neither are patients who receive nutrition through a tube, or who have life-threatening food allergies.

How will it work

Patients will be randomly assigned to one of three groups. Group A will receive MTM for 12 weeks. Meals are based on guidelines of the American Diabetes Association and can be adjusted for dietary needs. Group B will also receive MTM. Additionally, they will receive one year of training with a registered dietician via remote tele-visits. Group C will receive usual care, which includes regular visits with a diabetes provider.

Patients will be followed up for up to 12 months. The main outcomes will be changes in HbA1c, weight and quality of life of participants.

Clinical trial locations

Locations near

14202, United States

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Type: Interventional
Participants: 600
Study ID: NCT04264572
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