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

Sponsor

Emory University (Other)

Overall Status

Terminated

CT.gov ID

NCT00743756

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Diabetes	Dietary Supplement: home-delivered meals Dietary Supplement: home-delivered meals Behavioral: diabetes education for 12 months	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Study of a Home Delivered Meal Program on Obese Elderly African American Subjects With T2Dm

Study Start Date :

Apr 1, 2006

Actual Primary Completion Date :

Feb 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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)	Dietary Supplement: home-delivered meals 3 diabetic meals per day, 7 days per week for 12 months
Experimental: 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)	Dietary Supplement: home-delivered meals diabetic meals 3 times per day, 7 days a week for six months
Other: 3 20 subjects received 12 months of diabetes education (8 clinic visits and 8 phone calls)	Behavioral: diabetes education for 12 months subjects in this group received diabetes education for 12 months

Arm

Intervention/Treatment

Experimental: 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)

Dietary Supplement: home-delivered meals

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

Experimental: 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)

Dietary Supplement: home-delivered meals

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

Other: 3

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

Behavioral: diabetes education for 12 months

subjects in this group received diabetes education for 12 months

Outcome Measures

Primary Outcome Measures

Weight Loss in the elderly african american population [6 months to 1 year]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

African-American subjects
Males or females 65 - 85 years of age
Body mass index (BMI) equal to or greater than 30 kg/m2
Fasting blood glucose less than 300 mg/dL and HbA1c less than 9.0%
Ability to understand and be willing to adhere to the study protocol
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:

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