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OpenTrials
Completed

NCT Number: NCT01244152

Self-Management in African Americans With Diabetes and Hypertension

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Enhanced standard diabetes education

Behavioral

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

Primary outcomes

  1. Weight change

Secondary outcomes

  1. Hemoglobin A1C

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

Lifestyle Improvement Through Food and Exercise (LIFE): Self-Management in African Americans With Diabetes and Hypertension

Acronym: LIFE

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 19, 2010
Registry last updated
Nov 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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