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

NCT01284465 | Completed

• 2 other identifiers: 081204AAH231 26U54RR026140-01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes self-management; Minority women; Barriers to diabetes self-management

Outcome Measures

Primary Outcomes (1)

• HbA1c

  glycosylated hemoglobin

  baseline, 6 and 12 months

Secondary Outcomes (1)

• Risk factors for co-morbidity and daily self-management behaviors

  baseline, 3, 6, 9 and 12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Education and patient liaison combination

Behavioral: Education and patient liaison combination

Control group

EXPERIMENTAL

Education only

Behavioral: Control group

Interventions

Education and patient liaison combination BEHAVIORAL

Group education sessions with Patient liaison using ecological momentary assessment principles

Also known as: Type 2 diabetes self-management, Low-income women, Barriers to diabetes self-care

Intervention group

Control group BEHAVIORAL

Group education sessions at baseline, 3 and 6 months

Also known as: Type 2 diabetes self-management, Low-income women, Barriers to diabetes self-care

Control group

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meharry Medical College: lead
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Meharry medical College

Nashville, Tennessee, 37208, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Educational Status; Control Groups

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Sylvie A Akohoue, PhD

  Meharry Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 25, 2011
• First Posted: January 27, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: April 7, 2015

Record last verified: 2015-04

Locations

US (1)