MedDataX Logo

Self-Management in African Americans With Diabetes and Hypertension

NCT ID: NCT01244152

Last Updated: 2010-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

Group Type EXPERIMENTAL

Intensive diabetes self-management education

Intervention Type 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.

Control Group

Group Type ACTIVE_COMPARATOR

Enhanced standard diabetes education

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Enhanced standard diabetes education

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rush University Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rush University Medical Center

Chicago, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 24874782 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DK074485-01A2

Identifier Type: -

Identifier Source: org_study_id