Clinical trial NCT01244152: Self-Management in African Americans With Diabetes and Hypertension
Official title: Lifestyle Improvement Through Food and Exercise (LIFE): Self-Management in African Americans With Diabetes and Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2010-11-19
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Weight change
Secondary outcomes:
measure: Hemoglobin A1C
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References:
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.