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

Rush

Status and phase

Completed

Phase 2

Conditions

Diabetes

Treatments

Behavioral: Intensive diabetes self-management education

Behavioral: Enhanced standard diabetes education

Study type

Interventional

Funder types

Other

Identifiers

NCT01244152

DK074485-01A2

Details and patient eligibility

About

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.

Enrollment

59 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.