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

NCT ID: NCT01284465

Last Updated: 2015-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2014-12-31

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention group

Education and patient liaison combination

Group Type: EXPERIMENTAL

Education and patient liaison combination

Intervention Type: BEHAVIORAL

Group education sessions with Patient liaison using ecological momentary assessment principles

Control group

Education only

Group Type: EXPERIMENTAL

Control group

Intervention Type: BEHAVIORAL

Group education sessions at baseline, 3 and 6 months

Interventions

Education and patient liaison combination

Group education sessions with Patient liaison using ecological momentary assessment principles

Intervention Type: BEHAVIORAL

Control group

Group education sessions at baseline, 3 and 6 months

Intervention Type: BEHAVIORAL

Other Intervention Names

Type 2 diabetes self-management; Low-income women; Barriers to diabetes self-care; Type 2 diabetes self-management; Low-income women; Barriers to diabetes self-care

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Research Resources (NCRR)

NIH

Sponsor Role: collaborator

Meharry Medical College

OTHER

Sponsor Role: lead

Responsible Party

Sylvie Akohoue

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sylvie A Akohoue, PhD

Role: PRINCIPAL_INVESTIGATOR

Meharry Medical College

Locations

Meharry medical College

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

U54RR026140-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

081204AAH231 26

Identifier Type: -

Identifier Source: org_study_id