Study of a Home Delivered Meal Program on Obese Elderly African American Subjects With Type 2 Diabetes Mellitus (DM)

Emory University

Status: Terminated

Conditions: Diabetes; Obesity

Treatments: Dietary Supplement: home-delivered meals; Behavioral: diabetes education for 12 months

Study type: Interventional

Funder types: Other

Identifiers

NCT00743756

1404-2005

Details and patient eligibility

About

The purpose of this study is to assess the impact of home-delivered Medical Nutrition Therapy on clinical outcomes for persons with diabetes. The primary outcomes of this studies include A1c (A1C), blood glucose, blood pressure, Body Mass Index, lipid levels and other measures of disease progression and management as well as costs of medical care provided throughout the intervention period.

Full description

Data collected as a result of this project will be evaluated in aggregate to demonstrate the potential impacts on health and medical costs available through this type of intervention, with long-term goals of reducing disability and deaths due to chronic disease.

Enrollment: 38 patients

Sex: All

Ages: 65 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. African-American subjects
2. Males or females 65 - 85 years of age
3. Body mass index (BMI) equal to or greater than 30 kg/m2
4. Fasting blood glucose less than 300 mg/dL and HbA1c less than 9.0%
5. Ability to understand and be willing to adhere to the study protocol
6. A known history of type 2 diabetes mellitus greater than 3 months, receiving either diet alone or oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones).

Exclusion criteria

1. Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state.
2. Patients with clinically relevant hepatic disease or impaired renal function, as shown by a serum creatinine greater than 3.0 mg/dL.
3. Mental condition rendering the subject unable to understand the scope of the study.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 3 patient groups

1

Experimental group

Description:

A total of 20 African-American patients with type 2 diabetes will be randomized to receive home-delivered meals for twelve consecutive months. In addition, the subjects received diabetes education at every visit (8 clinic visits and 8 phone calls)

Treatment:

Dietary Supplement: home-delivered meals

Dietary Supplement: home-delivered meals

2

Experimental group

Description:

A total of 20 African-American patients with type 2 diabetes will be randomized to receive home-delivered meals for six consecutive months. In addition, the subjects received diabetes education for up to twelve months(8 clinic visits and 8 phone calls)

Treatment:

Dietary Supplement: home-delivered meals

Dietary Supplement: home-delivered meals

3

Other group

Description:

20 subjects received 12 months of diabetes education (8 clinic visits and 8 phone calls)

Treatment:

Behavioral: diabetes education for 12 months