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Completed

NCT Number: NCT01284465

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

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.

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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Meharry medical College

Nashville, Tennessee, 37208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Education and patient liaison combination

Behavioral

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

Control Group

Behavioral

Group education sessions at baseline, 3 and 6 months

Other names: Type 2 diabetes self-management, Low-income women, Barriers to diabetes self-care

Primary outcomes

  1. HbA1c

    Time frame: baseline, 6 and 12 months

    glycosylated hemoglobin

Secondary outcomes

  1. Risk factors for co-morbidity and daily self-management behaviors

    Time frame: baseline, 3, 6, 9 and 12 months

    • -Risk factors for co-morbidity:
    • -Daily self-management behaviors

Sponsors and collaborators

Lead sponsor

Meharry Medical College

Other

Collaborators

  • National Center for Research Resources (NCRR)

Registry information

Official study title

A Comprehensive Approach to Type 2 Diabetes Self-management for Low-income Women

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jan 27, 2011
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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