Self-Management in African Americans With Diabetes and Hypertension

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: Intensive diabetes self-management education
* Behavioral: Enhanced standard diabetes education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Behavioral: Intensive diabetes self-management education<br>* 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.<br>|
| Active Comparator: Control Group<br> | Behavioral: Enhanced standard diabetes education<br>* 2 3-hour diabetes education classes taught by a health educator at a local clinic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1C |  |  |