Back to resultsSelf-Management in African Americans With Diabetes and Hypertension (LIFE)
Primary Purpose
Diabetes
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Intensive diabetes self-management education
Enhanced standard diabetes education
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes
Eligibility Criteria
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.
Sites / Locations
- Rush University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control Group
Arm Description
Outcomes
Primary Outcome Measures
Weight change
Secondary Outcome Measures
Hemoglobin A1C
Full Information
NCT ID
NCT01244152
First Posted
November 17, 2010
Last Updated
November 18, 2010
Sponsor
Rush University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01244152
Brief Title
Self-Management in African Americans With Diabetes and Hypertension
Acronym
LIFE
Official Title
Lifestyle Improvement Through Food and Exercise (LIFE): Self-Management in African Americans With Diabetes and Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Rush University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Intensive diabetes self-management education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced standard diabetes education
Intervention Description
2 3-hour diabetes education classes taught by a health educator at a local clinic
Primary Outcome Measure Information:
Title
Weight change
Secondary Outcome Measure Information:
Title
Hemoglobin A1C
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24874782
Citation
Lynch EB, Liebman R, Ventrelle J, Avery EF, Richardson D. A self-management intervention for African Americans with comorbid diabetes and hypertension: a pilot randomized controlled trial. Prev Chronic Dis. 2014 May 29;11:E90. doi: 10.5888/pcd11.130349.
Results Reference
derived
Learn more about this trial
Self-Management in African Americans With Diabetes and Hypertension
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