NCT00142922

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

March 2, 2010

Status Verified

March 1, 2010

First QC Date

August 31, 2005

Last Update Submit

March 1, 2010

Conditions

Type 1 DiabetesType 2 Diabetes

Keywords

Adherenceself-careBehavioral interventionDiabetes

Outcome Measures

Primary Outcomes (3)

  • Self-Care Behaviors

  • Glycemic control (HbA1c)

  • fitness

Secondary Outcomes (2)

  • Quality of life

  • Diabetes Related emaitonal distress

Study Arms (3)

1

EXPERIMENTAL

Attended Breaking Down Barriers program

Behavioral: Breaking Down Barriers

2

ACTIVE COMPARATOR

Attention control group

Behavioral: Breaking Down Barriers

3

ACTIVE COMPARATOR

Indivdual attention control group

Behavioral: Breaking Down Barriers

Interventions

Breaking Down BarriersBEHAVIORAL

completed

123

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For Patients With Type 1 Diabetes
  • Aged 18-65
  • Presence of type 1 diabetes mellitus.
  • year duration.
  • For Patients With Type 2 Diabetes
  • Aged 25-65 years
  • presence of type 2 diabetes mellitus.
  • years since initial diagnosis.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • 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.

    PMID: 21986346DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Katie Weinger, EdD

    Joslin Diabetes Center/Harvard Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 2, 2005

Study Start

October 1, 2002

Study Completion

October 1, 2007

Last Updated

March 2, 2010

Record last verified: 2010-03

Locations

US(1)