EMPOWERTailored Small Changes Intervention for Diabetes Management in Rural African American Women
This study aims to evaluate the effectiveness of a tailored small changes intervention in managing diabetes, specifically focusing on changes in Hemoglobin A1c levels in rural African American women.
Educational Control Arm
+ Lifestyle Counseling
Diabetes Mellitus+3
+ Endocrine System Diseases
+ Metabolic Diseases
Treatment Study
Summary
Study start date: January 1, 2012
Actual date on which the first participant was enrolled.East Carolina University, along with established community partners, is implementing a community-based and culturally-tailored intervention to reduce diabetes disparities in 200 rural African American women with uncontrolled diabetes using our unique behaviorally-centered small changes approach to diabetes self-management, delivered by community health workers. The focus is on moderation and patient-selected small changes in eating, activity, and care management that decrease feelings of deprivation and failure and increase feelings of confidence and success. The intervention is specifically tailored to overcome psychosocial and environmental barriers to behavioral change through a strong focus on emotional, cultural, and social factors related to eating, activity, and medications. Objectives for the proposed project are to: 1) implement and evaluate the effectiveness of this tailored small changes intervention; 2) examine the impact of this approach on psychological mediators of behavioral choices in diabetes; 3) implement and evaluate public policy and built environment advocacy strategies; and 4) build, sustain, and disseminate a business-sustainable care model. The study will be a randomized prospective trial comparing the small changes intervention, delivered in 16 sessions by community health workers, to a control group receiving 16 mailings of diabetes educational materials. We hypothesize that there will be a greater improvement in behavioral choices and glycemic control in the intervention group compared to the control group.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.200 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 19 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: African American female, age 19 - 75yr., with Type 2 diabetes mellitus and living in or near Bertie, Edgecombe, and Pitt counties in eastern NC Exclusion Criteria: -
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location