Self-Management in African Americans With Diabetes and Hypertension

Phase 2

Completed

• Conditions: Diabetes
• Interventions: Behavioral: Intensive diabetes self-management education; Behavioral: Enhanced standard diabetes education

• Registration Number: NCT01244152
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2010-11
• Study First Submitted: 2010-11-17
• Study First Submitted QC: 2010-11-18
• Last Update Submitted: 2010-11-18
• Study First Posted: 2010-11-19
• Last Update Posted: 2010-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Intensive diabetes self-management education	-
Control Group	Enhanced standard diabetes education	-

Primary Outcome Measures

Name	Time	Method
Weight change

Secondary Outcome Measures

Name	Time	Method
Hemoglobin A1C

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States