Self-Management in African Americans With Diabetes and Hypertension

Diabetes Clinical Trial

— LIFE  

Official title:

Lifestyle Improvement Through Food and Exercise (LIFE): Self-Management in African Americans With Diabetes and Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01244152
• Other study ID #: DK074485-01A2
• Status: Completed
• Phase: Phase 2
• First received: November 17, 2010
• Last updated: November 18, 2010
• Start date: July 2008
• Est. completion date: July 2010

Study information

• Verified date: November 2010
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes

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.
• Enhanced standard diabetes education
2 3-hour diabetes education classes taught by a health educator at a local clinic

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight change			No
Secondary	Hemoglobin A1C			No