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Breaking Down Barriers to Diabetes Self-Care

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ClinicalTrials.gov Identifier: NCT00142922
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : March 2, 2010
Information provided by:

August 31, 2005
September 2, 2005
March 2, 2010
October 2002
Not Provided
  • Self-Care Behaviors
  • Glycemic control (HbA1c)
  • fitness
Same as current
Complete list of historical versions of study NCT00142922 on ClinicalTrials.gov Archive Site
  • Quality of life
  • Diabetes Related emaitonal distress
Same as current
Not Provided
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Breaking Down Barriers to Diabetes Self-Care
Breaking Down Barriers to Diabetes Self-Care
Performance of self-care recommendations is key to the successful treatment of diabetes. However, many patients have difficulty adhering to diabetes self-care recommendations. Recent results from our own studies and others have identified specific barriers to diabetes self-care. To evaluate the efficacy of a diabetes educator-led group intervention, the Breaking Down Barriers Program, that addresses barriers and therefore leads to improved adherence to diabetes self-care recommendations, we will randomize 222 (111 type 1 and 111 type 2) diabetes patients to one of three conditions: 1) the Breaking Down Barriers Program, 2) a cholesterol attention control condition, or 3) a 'usual care' control condition. We hypothesize that those assigned to the Breaking Down Barriers group will improve self-care behaviors and glycemic control more than those in the two control groups. We will follow study subjects for one year to determine whether their self-care behaviors and glycemic control improved and if the improvement was maintained over time.
Not Provided
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
  • Type 1 Diabetes
  • Type 2 Diabetes
Behavioral: Breaking Down Barriers
  • Experimental: 1
    Attended Breaking Down Barriers program
    Intervention: Behavioral: Breaking Down Barriers
  • Active Comparator: 2
    Attention control group
    Intervention: Behavioral: Breaking Down Barriers
  • Active Comparator: 3
    Indivdual attention control group
    Intervention: Behavioral: Breaking Down Barriers
Weinger K, Beverly EA, Lee Y, Sitnokov L, Ganda OP, Caballero AE. The effect of a structured behavioral intervention on poorly controlled diabetes: a randomized controlled trial. Arch Intern Med. 2011 Dec 12;171(22):1990-9. doi: 10.1001/archinternmed.2011.502. Epub 2011 Oct 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
October 2007
Not Provided

Inclusion Criteria:

For Patients With Type 1 Diabetes

  • Aged 18-65
  • Presence of type 1 diabetes mellitus.
  • 2-25 year duration.

For Patients With Type 2 Diabetes

  • Aged 25-65 years
  • presence of type 2 diabetes mellitus.
  • 2 years since initial diagnosis.

Exclusion Criteria:

  • Renal disease, microalbumin >300 ug/mg)
  • Severe peripheral diabetic neuropathy and/or severe peripheral vascular disease
  • Symptomatic severe autonomic neuropathy who may be at risk when increasing activity levels.
  • Women who are currently pregnant
  • proliferative diabetic retinopathy based on dilated eye examination within one year of study entry. Patients whose eye disease is successfully treated will be included.
  • HbA1c levels less than 7.0% (normal range 4.0 - 6.0%).
  • HbA1c levels greater than 14.0%
  • patients who underwent intensive insulin treatment within one year
  • a history of severe, unstable myocardial infarction, congestive heart failure or other severe cardiac disease, severe hypertension (systolic more than 160 mmHg or diastolic 90 mmHg) who may be at risk when mildly increasing physical activity
  • a DSMIV diagnosis of eating disorders including anorexia nervosa, bulimia, and severe weight-related insulin omission.
  • Patients with recent diagnosis (past 6 months) of bipolar disorder, schizophrenia, mental retardation, organic mental disorder, and alcohol or drug abuse
  • Patients whose diabetes diagnosed cannot be clearly classified as type 1 or type 2.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
DK 60115 (completed)
DK 60115
Not Provided
Not Provided
Not Provided
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Principal Investigator: Katie Weinger, EdD Joslin Diabetes Center/Harvard Medical School
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP