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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01284465
• Other study ID #: 081204AAH231 26
• Secondary ID: U54RR026140-01
• Status: Completed
• Phase: N/A
• First received: January 25, 2011
• Last updated: April 6, 2015
• Start date: January 2011
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: Meharry Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Education and patient liaison combination
Group education sessions with Patient liaison using ecological momentary assessment principles
• Control group
Group education sessions at baseline, 3 and 6 months

Locations

Country	Name	City	State
United States	Meharry medical College	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Meharry Medical College	National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	glycosylated hemoglobin	baseline, 6 and 12 months	No
Secondary	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	No