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

June 7, 2014 updated by: Guillermo Umpierrez, Emory University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Grady Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Dietary supplement: home-delivered meals
diabetic meals 3 times per day, 7 days a week for six 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
3 diabetic meals per day, 7 days per week for 12 months
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight Loss in the elderly african american population
Time Frame: 6 months to 1 year
6 months to 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Endothelial Function (assessed by pulse-wave analysis); sympathetic activity; insulin sensitivity
Time Frame: 6 months to 1 year
6 months to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Guillermo E Umpierrez, MD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

August 27, 2008

First Submitted That Met QC Criteria

August 28, 2008

First Posted (Estimate)

August 29, 2008

Study Record Updates

Last Update Posted (Estimate)

June 10, 2014

Last Update Submitted That Met QC Criteria

June 7, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1404-2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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