Improving Diabetes Outcomes for Persons With Severe Mental Illness
- Conditions
- Diabetes
- Interventions
- Behavioral: Diabetes self-management and education
- Registration Number
- NCT02053714
- Lead Sponsor
- University of North Carolina, Chapel Hill
- Brief Summary
Persons with severe mental illness are at great risk for developing type 2 diabetes (T2DM). Unfortunately, persons with mental illness and T2DM are less likely to receive recommended diabetes monitoring and are more likely to have poorly controlled diabetes, which leads to microvascular and macrovascular complications later in life. Evidence-based diabetes self-management education and support interventions have yet to be adapted for persons with mental illness and there have been no randomized controlled trials (RCTs) to examine their feasibility and efficacy. The purpose of this study is to assess the feasibility of conducting a RCT of a diabetes self-management intervention for persons with severe mental illness and T2DM.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Type 2 diabetes plus severe mental illness -
None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Self-management and education group Diabetes self-management and education Self-management and education group - 8 weeks of group-based information and activities designed to improve diabetes self-management
- Primary Outcome Measures
Name Time Method Changes in knowledge of diabetes self-management from baseline to six months as evidenced by scores on the Stanford Diabetes Self-Management Questionnaire. Baseline, 6 months
- Secondary Outcome Measures
Name Time Method Changes in HBA1c values from baseline to six months. Baseline, 6 months Changes in subscapular skinfold measurement from baseline to 6 months. Baseline, 6 months Changes in eating self-efficacy from baseline to six months as evidenced by scores on a standardized measure of eating self-efficacy. Baseline, 6 months Glynn and Ruderman's (1986) eating self-efficacy scale will be used.
Glynn, S.M., \& Ruderman, J. (1986). The development and validation of an eating self-efficacy scale. Cognitive Therapy and Research, 10, 403-420.Changes in health promoting activities from baseline to six months as evidenced by scores on a standardized measure of health promoting lifestyle activities. Baseline, 6 months Changes in waist circumference from baseline to six months. Baseline, 6 months Changes in body mass index from baseline to six months. Baseline, 6 months Changes in diabetes self-efficacy from baseline to six months as evidenced by scores on the Stanford Diabetes Self-Efficacy Questionnaire. Baseline, 6 months Changes in healthy lifestyle activities from baseline to six months as evidenced by scores on a standardized measure of adult health behavior. Baseline, 6 months Changes in triceps circumference from baseline to six months. Baseline, 6 months Changes in exercise self-efficacy from baseline to six months as evidenced by scores on a standardized measure of exercise self-efficacy. Baseline, 6 months Bandura's exercise self-efficacy scale will be used. Bandura, A. (1997). Self-efficacy: The exercise of control. New York: W.H. Freeman.
Changes in diastolic and systolic blood pressure from baseline to six months. Baseline, 6 months
Trial Locations
- Locations (1)
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States