Self-Management in African Americans With Diabetes and Hypertension (LIFE)
This study has been completed.
Sponsor:
Rush University Medical Center
Information provided by:
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01244152
First received: November 17, 2010
Last updated: November 18, 2010
Last verified: November 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes |
Behavioral: Intensive diabetes self-management education Behavioral: Enhanced standard diabetes education |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Lifestyle Improvement Through Food and Exercise (LIFE): Self-Management in African Americans With Diabetes and Hypertension |
Resource links provided by NLM:
Further study details as provided by Rush University Medical Center:
Primary Outcome Measures:
- Weight change [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Hemoglobin A1C [ Designated as safety issue: No ]
| Enrollment: | 59 |
| Study Start Date: | July 2008 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Intervention |
Behavioral: 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.
|
| Active Comparator: Control Group |
Behavioral: Enhanced standard diabetes education
2 3-hour diabetes education classes taught by a health educator at a local clinic
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Elizabeth Lynch, Rush University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01244152 History of Changes |
| Other Study ID Numbers: | DK074485-01A2 |
| Study First Received: | November 17, 2010 |
| Last Updated: | November 18, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Diabetes Mellitus Hypertension Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013