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

This study has been completed.
Information provided by:
Rush University Medical Center Identifier:
First received: November 17, 2010
Last updated: November 18, 2010
Last verified: November 2010
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 Intervention Phase
Diabetes Behavioral: Intensive diabetes self-management education Behavioral: Enhanced standard diabetes education Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Weight change

Secondary Outcome Measures:
  • Hemoglobin A1C

Enrollment: 59
Study Start Date: July 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.
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Please refer to this study by its identifier: NCT01244152

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

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
Study First Received: November 17, 2010
Last Updated: November 18, 2010

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on September 20, 2017