Self-Management in African Americans With Diabetes and Hypertension

NCT01244152 | Completed Phase 2

• 1 other identifier: DK074485-01A2
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Weight change

Secondary Outcomes (1)

• Hemoglobin A1C

Study Arms (2)

Intervention

EXPERIMENTAL

Behavioral: Intensive diabetes self-management education

Control Group

ACTIVE COMPARATOR

Behavioral: Enhanced standard diabetes education

Interventions

Intensive diabetes self-management education BEHAVIORAL

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

Enhanced standard diabetes education BEHAVIORAL

2 3-hour diabetes education classes taught by a health educator at a local clinic

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• BMI ≥ 25. Participant must be overweight because the main goal of our intervention is weight loss of 5% or more of initial body weight.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• 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.

  PMID: 24874782 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 19, 2010
• Study Start: July 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: November 19, 2010

Record last verified: 2010-11

Locations

US (1)