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

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Education and patient liaison combination; Behavioral: Control group

• Registration Number: NCT01284465
• Lead Sponsor: Meharry Medical College

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-25
• Study First Submitted QC: 2011-01-25
• Study First Posted: 2011-01-27
• Primary Completion: 2013-12
• Study Completion: 2014-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Education and patient liaison combination	Education and patient liaison combination
Control group	Control group	Education only

Primary Outcome Measures

Name	Time	Method
HbA1c	baseline, 6 and 12 months	glycosylated hemoglobin

Secondary Outcome Measures

Name	Time	Method
Risk factors for co-morbidity and daily self-management behaviors	baseline, 3, 6, 9 and 12 months	1. -Risk factors for co-morbidity: 2. -Daily self-management behaviors

Trial Locations

Locations (1)

Meharry medical College; 🇺🇸 Nashville, Tennessee, United States