Clinical trial NCT01284465: Type 2 Diabetes Self-management Intervention for Low-income Women
Official title: A Comprehensive Approach to Type 2 Diabetes Self-management for Low-income Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes self-management
Minority women
Barriers to diabetes self-management
Lead sponsor: Meharry Medical College
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2011-01-27
Enrollment: 56
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: HbA1c
timeFrame: baseline, 6 and 12 months
Secondary outcomes:
measure: Risk factors for co-morbidity and daily self-management behaviors
timeFrame: baseline, 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Meharry medical College
state: Tennessee
Study officials:
affiliation: Meharry Medical College
name: Sylvie A Akohoue, PhD
role: PRINCIPAL_INVESTIGATOR
References: