Self-Management in African Americans With Diabetes and Hypertension (LIFE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01244152
Recruitment Status : Completed
First Posted : November 19, 2010
Last Update Posted : November 19, 2010
Information provided by:
Rush University Medical Center

Brief Summary:
The primary aim of the study is to design a group-based, culturally appropriate self-management skills training intervention for disadvantaged African-Americans with both diabetes and hypertension and to compile an intervention Manual of Operations (MOO). The investigators are developing an intervention to assist individuals in reducing weight and hemoglobin A1c.

Condition or disease Intervention/treatment Phase
Diabetes Behavioral: Intensive diabetes self-management education Behavioral: Enhanced standard diabetes education Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Lifestyle Improvement Through Food and Exercise (LIFE): Self-Management in African Americans With Diabetes and Hypertension
Study Start Date : July 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intervention Behavioral: Intensive diabetes self-management education
18 group classes led by a dietitian and peer supporters, and weekly telephone calls by peer supporters. Intervention focus was on diet and physical activity.
Active Comparator: Control Group Behavioral: Enhanced standard diabetes education
2 3-hour diabetes education classes taught by a health educator at a local clinic

Primary Outcome Measures :
  1. Weight change

Secondary Outcome Measures :
  1. Hemoglobin A1C

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of type 2 diabetes mellitus (HgA1c>7%), requiring the patient to take at least one tablet per day or one insulin injection per day and a diagnosis of hypertension (130/80) requiring them to take at least one medication per day;
  • Participants must identify themselves as African-American;
  • Participant resides in or proximal to the North Lawndale neighborhood;
  • Secure written permission from their physician to engage in moderate physical activity. This set of participants may be at high risk for cardiac disease and this exclusion avoids putting them at undue risk;
  • BMI ≥ 25. Participant must be overweight because the main goal of our intervention is weight loss of 5% or more of initial body weight.

Exclusion Criteria:

  • Diet-controlled diabetes;
  • Hypertension controlled with lifestyle modification only;
  • Endstage renal disease, stroke with paresis, congestive heart failure (NYHA class 3 or 4), or other major endorgan complication of diabetes;
  • Comorbid conditions limiting probable life span to <4 years (e.g. cancer, AIDS) or indication of end-stage complications of diabetes (kidney dialysis, or transplant, blindness, or lower extremity amputation);
  • Receiving treatment for a major psychiatric disorder (i.e. schizophrenia);
  • Unable to give informed consent;
  • Are under the age of 18-While type-2 diabetes and hypertension are increasing in those under the age of 18, adolescent medicine is a separate specialty area from adult medicine. Interventions should be targeted specifically toward this age group to take into consideration the specific emotional and psychological needs of adolescents;
  • Alcoholism as measured by the CAGE.screener for alcohol abuse.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01244152

United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Elizabeth Lynch, Rush University Medical Center Identifier: NCT01244152     History of Changes
Other Study ID Numbers: DK074485-01A2
First Posted: November 19, 2010    Key Record Dates
Last Update Posted: November 19, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases