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

This study is currently recruiting participants.
Verified July 2012 by Meharry Medical College
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Sylvie Akohoue, Meharry Medical College
ClinicalTrials.gov Identifier:
NCT01284465
First received: January 25, 2011
Last updated: July 10, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Type 2 Diabetes
 Behavioral: Education and patient liaison combination
Behavioral: Control group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Comprehensive Approach to Type 2 Diabetes Self-management for Low-income Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Meharry Medical College:

Primary Outcome Measures:
  • HbA1c [ Time Frame: baseline, 6 and 12 months ] [ Designated as safety issue: No ]
    glycosylated hemoglobin


Secondary Outcome Measures:
  • Risk factors for co-morbidity and daily self-management behaviors [ Time Frame: baseline, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
    1. -Risk factors for co-morbidity:
    2. -Daily self-management behaviors


Estimated Enrollment: 80
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention group
Education and patient liaison combination
 Behavioral: Education and patient liaison combination
Group education sessions with Patient liaison using ecological momentary assessment principles
Other Names:
  • Type 2 diabetes self-management
  • Low-income women
  • Barriers to diabetes self-care
Experimental: Control group
Education only
 Behavioral: Control group
Group education sessions at baseline, 3 and 6 months
Other Names:
  • Type 2 diabetes self-management
  • Low-income women
  • Barriers to diabetes self-care

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284465

Contacts
Contact: Sylvie A Akohoue, PhD 615-327-6771 sakohoue@mmc.edu

Locations
United States, Tennessee
Meharry medical College Recruiting
Nashville, Tennessee, United States, 37208
Contact: Sylvie Akohoue, PhD     615-327-6771     sakohoue@mmc.edu    
Principal Investigator: Sylvie Akohoue, PhD            
Sponsors and Collaborators
Meharry Medical College
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Sylvie A Akohoue, PhD Meharry Medical College
  More Information

No publications provided

Responsible Party: Sylvie Akohoue, Assistant Professor, Meharry Medical College
ClinicalTrials.gov Identifier: NCT01284465     History of Changes
Other Study ID Numbers: 081204AAH231 26, U54RR026140-01
Study First Received: January 25, 2011
Last Updated: July 10, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Meharry Medical College:
Type 2 diabetes self-management
Minority women
Barriers to diabetes self-management

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013