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

Not Applicable

Terminated

• Conditions: Obesity; Diabetes
• Interventions: Dietary Supplement: home-delivered meals; Behavioral: diabetes education for 12 months

• Registration Number: NCT00743756
• Lead Sponsor: Emory University

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.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2008-08-27
• Study First Submitted QC: 2008-08-28
• Study First Posted: 2008-08-29
• Primary Completion: 2009-02
• Study Completion: 2009-12
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-07
• Last Update Posted: 2014-06-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	home-delivered meals	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)
2	home-delivered meals	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)
3	diabetes education for 12 months	20 subjects received 12 months of diabetes education (8 clinic visits and 8 phone calls)

Primary Outcome Measures

Name	Time	Method
Weight Loss in the elderly african american population	6 months to 1 year

Secondary Outcome Measures

Name	Time	Method
Endothelial Function (assessed by pulse-wave analysis); sympathetic activity; insulin sensitivity	6 months to 1 year

Trial Locations

Locations (1)

Grady Health System; 🇺🇸 Atlanta, Georgia, United States