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

NCT ID: NCT00743756

Last Updated: 2014-06-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2009-12-31

Brief Summary

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.

Detailed 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.

Conditions

Obesity; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

1

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)

Group Type: EXPERIMENTAL

home-delivered meals

Intervention Type: DIETARY_SUPPLEMENT

3 diabetic meals per day, 7 days per week for 12 months

2

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)

Group Type: EXPERIMENTAL

home-delivered meals

Intervention Type: DIETARY_SUPPLEMENT

diabetic meals 3 times per day, 7 days a week for six months

3

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

Group Type: OTHER

diabetes education for 12 months

Intervention Type: BEHAVIORAL

subjects in this group received diabetes education for 12 months

Interventions

home-delivered meals

3 diabetic meals per day, 7 days per week for 12 months

Intervention Type: DIETARY_SUPPLEMENT

home-delivered meals

diabetic meals 3 times per day, 7 days a week for six months

Intervention Type: DIETARY_SUPPLEMENT

diabetes education for 12 months

subjects in this group received diabetes education for 12 months

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Guillermo Umpierrez

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guillermo E Umpierrez, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Grady Health System

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

1404-2005

Identifier Type: -

Identifier Source: org_study_id