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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Education and patient liaison combination
* Behavioral: Control group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Education and patient liaison combination | Behavioral: Education and patient liaison combination<br>* Group education sessions with Patient liaison using ecological momentary assessment principles<br>* Other names: Barriers to diabetes self-care;|
| Experimental: Control group<br>Education only | Behavioral: Control group<br>* Group education sessions at baseline, 3 and 6 months<br>* Other names: Barriers to diabetes self-care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | glycosylated hemoglobin | baseline, 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors for co-morbidity and daily self-management behaviors | -Risk factors for co-morbidity: -Daily self-management behaviors | baseline, 3, 6, 9 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes self-management, Minority women, Barriers to diabetes self-management