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Type 2 Diabetes Self-management Intervention for Low-income Women

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education and patient liaison combination
Control group
Sponsored by
Meharry Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes focused on measuring Type 2 diabetes self-management, Minority women, Barriers to diabetes self-management

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Low-income women ages 21 and older; With type 2 diabetes ( fasting plasma glucose > 126 mg/dl);
  2. At risk of developing diabetes related complications (treatments goals from The American Diabetes Association Standards of medical care) as defined by:

    • HbA1c >8.0 %
    • Any of the metabolic clusters such as Pre-prandial plasma glucose > 130 mg/dl; Obesity (BMI >25 kg/m2, or waist circumference >88 cm (>35 in); Hypertension (Systolic >130 and Diastolic > 80 mmHg); Hyperlipidemia (Triglycerides >150 mg/dL; HDL<50 mg/dL; LDL >100 mg/dL)

Exclusion Criteria:

  • Participants will be excluded if they are currently pregnant, have conditions (i.e., end stage diagnosis) or behaviors likely to affect conduct of the trial, and unwilling to accept treatment assignment by randomization.

Sites / Locations

  • Meharry medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention group

Control group

Arm Description

Education and patient liaison combination

Education only

Outcomes

Primary Outcome Measures

HbA1c
glycosylated hemoglobin

Secondary Outcome Measures

Risk factors for co-morbidity and daily self-management behaviors
-Risk factors for co-morbidity: -Daily self-management behaviors

Full Information

First Posted
January 25, 2011
Last Updated
April 6, 2015
Sponsor
Meharry Medical College
Collaborators
National Center for Research Resources (NCRR)
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1. Study Identification

Unique Protocol Identification Number
NCT01284465
Brief Title
Type 2 Diabetes Self-management Intervention for Low-income Women
Official Title
A Comprehensive Approach to Type 2 Diabetes Self-management for Low-income Women
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meharry Medical College
Collaborators
National Center for Research Resources (NCRR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the extent to which a culturally appropriate, self-management intervention that combines patient education with a patient outreach liaison strategy improves outcomes associated with type-2 diabetes among low-income diabetic women.
Detailed Description
In recent years, the prevalence of diabetes has significantly increased among women and because of the expected fast growth rate of minority populations, the number of women in these groups who will be diagnosed with diabetes is also expected to increase significantly over the coming years. Among women from minority groups diabetes is the fourth leading cause of death while it is the seventh among non-Hispanic White females. Non-compliance to diabetes self-care is a major concern for type 2 diabetic women of racial/ethnic groups because of the existing socio-economic and environmental barriers. Often, these women live in poverty; have less than a high school education as well as language barriers and inadequate health literacy, which further place them at risk for complications, and the daily activities of diabetes self-care are implemented within the context of family responsibilities and patient's priorities. This study is a 12-month randomized controlled trial designed to compare a lifestyle intervention group (combination group) and a control group (education only group). Participants assigned to either group will receive three group education sessions (baseline, 3 and 6 months) with an emphasis on self-management.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 diabetes self-management, Minority women, Barriers to diabetes self-management

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Education and patient liaison combination
Arm Title
Control group
Arm Type
Experimental
Arm Description
Education only
Intervention Type
Behavioral
Intervention Name(s)
Education and patient liaison combination
Other Intervention Name(s)
Type 2 diabetes self-management, Low-income women, Barriers to diabetes self-care
Intervention Description
Group education sessions with Patient liaison using ecological momentary assessment principles
Intervention Type
Behavioral
Intervention Name(s)
Control group
Other Intervention Name(s)
Type 2 diabetes self-management, Low-income women, Barriers to diabetes self-care
Intervention Description
Group education sessions at baseline, 3 and 6 months
Primary Outcome Measure Information:
Title
HbA1c
Description
glycosylated hemoglobin
Time Frame
baseline, 6 and 12 months
Secondary Outcome Measure Information:
Title
Risk factors for co-morbidity and daily self-management behaviors
Description
-Risk factors for co-morbidity: -Daily self-management behaviors
Time Frame
baseline, 3, 6, 9 and 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Low-income women ages 21 and older; With type 2 diabetes ( fasting plasma glucose > 126 mg/dl); At risk of developing diabetes related complications (treatments goals from The American Diabetes Association Standards of medical care) as defined by: HbA1c >8.0 % Any of the metabolic clusters such as Pre-prandial plasma glucose > 130 mg/dl; Obesity (BMI >25 kg/m2, or waist circumference >88 cm (>35 in); Hypertension (Systolic >130 and Diastolic > 80 mmHg); Hyperlipidemia (Triglycerides >150 mg/dL; HDL<50 mg/dL; LDL >100 mg/dL) Exclusion Criteria: Participants will be excluded if they are currently pregnant, have conditions (i.e., end stage diagnosis) or behaviors likely to affect conduct of the trial, and unwilling to accept treatment assignment by randomization.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvie A Akohoue, PhD
Organizational Affiliation
Meharry Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meharry medical College
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208
Country
United States

12. IPD Sharing Statement

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Type 2 Diabetes Self-management Intervention for Low-income Women

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