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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01284465
First Posted: January 27, 2011
Last Update Posted: April 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Sylvie Akohoue, Meharry Medical College
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Sylvie Akohoue, Meharry Medical College:

Primary Outcome Measures:
  • HbA1c [ Time Frame: baseline, 6 and 12 months ]
    glycosylated hemoglobin


Secondary Outcome Measures:
  • Risk factors for co-morbidity and daily self-management behaviors [ Time Frame: baseline, 3, 6, 9 and 12 months ]
    1. -Risk factors for co-morbidity:
    2. -Daily self-management behaviors


Enrollment: 56
Study Start Date: January 2011
Study Completion Date: December 2014
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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01284465


Locations
United States, Tennessee
Meharry medical College
Nashville, Tennessee, United States, 37208
Sponsors and Collaborators
Meharry Medical College
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Sylvie A Akohoue, PhD Meharry Medical College
  More Information

Responsible Party: Sylvie Akohoue, Assistant Professor, Meharry Medical College
ClinicalTrials.gov Identifier: NCT01284465     History of Changes
Other Study ID Numbers: 081204AAH231 26
U54RR026140-01 ( U.S. NIH Grant/Contract )
First Submitted: January 25, 2011
First Posted: January 27, 2011
Last Update Posted: April 7, 2015
Last Verified: April 2015

Keywords provided by Sylvie Akohoue, 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