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OpenTrials
Completed

NCT Number: NCT02053714

Improving Diabetes Outcomes for Persons With Severe Mental Illness

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Type 2 diabetes plus severe mental illness -

Exclusion criteria

None

-

Treatment and study plan

Diabetes self-management and education

Behavioral

Primary outcomes

  1. Changes in knowledge of diabetes self-management from baseline to six months as evidenced by scores on the Stanford Diabetes Self-Management Questionnaire.

    Time frame: Baseline, 6 months

Secondary outcomes

  1. Changes in HBA1c values from baseline to six months.

    Time frame: Baseline, 6 months

  2. Changes in diabetes self-efficacy from baseline to six months as evidenced by scores on the Stanford Diabetes Self-Efficacy Questionnaire.

    Time frame: Baseline, 6 months

  3. Changes in eating self-efficacy from baseline to six months as evidenced by scores on a standardized measure of eating self-efficacy.

    Time frame: 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.

  4. Changes in exercise self-efficacy from baseline to six months as evidenced by scores on a standardized measure of exercise self-efficacy.

    Time frame: 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.

  5. Changes in healthy lifestyle activities from baseline to six months as evidenced by scores on a standardized measure of adult health behavior.

    Time frame: Baseline, 6 months

  6. Changes in health promoting activities from baseline to six months as evidenced by scores on a standardized measure of health promoting lifestyle activities.

    Time frame: Baseline, 6 months

  7. Changes in waist circumference from baseline to six months.

    Time frame: Baseline, 6 months

  8. Changes in triceps circumference from baseline to six months.

    Time frame: Baseline, 6 months

  9. Changes in subscapular skinfold measurement from baseline to 6 months.

    Time frame: Baseline, 6 months

  10. Changes in body mass index from baseline to six months.

    Time frame: Baseline, 6 months

  11. Changes in diastolic and systolic blood pressure from baseline to six months.

    Time frame: Baseline, 6 months

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • North Carolina Translational and Clinical Sciences Institute

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 4, 2014
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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