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Motivational Interviewing to Promote Maintenance of Physical Activity in People With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01067924
Recruitment Status : Completed
First Posted : February 12, 2010
Last Update Posted : July 21, 2014
Sponsor:
Information provided by (Responsible Party):
Marni Armstrong, University of Calgary

Brief Summary:

The purpose of the study is to assess the effectiveness of motivational interviewing in promoting maintenance of physical activity in people with Type 2 diabetes (T2D) upon the completion of a structured exercise program.

Participants with T2D who are new graduates of a supervised exercise program will be randomly assigned to either standard care (SC) or to standard care and in addition, participate in two individual motivational interview (MI) sessions (SC + MI).

The primary outcome will be change in physical activity behavior assessed by the Godin Leisure and Exercise questionnaire. Secondary outcomes will include change in blood glucose control (A1C), BMI, six minute walk-test, QoL, and self-efficacy.

Outcomes will be measured in groups at baseline, end of program, 3 months and 6 months post-program.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Motivational interviewing Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Motivational Interviewing to Promote Maintenance of Physical Activity in People With Type 2 Diabetes
Study Start Date : September 2009
Actual Primary Completion Date : April 2012
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Motivational interviewing Behavioral: Motivational interviewing
Intervention arm will receive 2 motivational interviewing session aimed at increasing maintenance of physical activity upon the completion of a supervised exercise program. Motivational interviews will occur at the end of the structured program and at 3 months post program completion. Outcomes will be collected at 6 months post-program.
Active Comparator: Standard of care Behavioral: Motivational interviewing
Intervention arm will receive 2 motivational interviewing session aimed at increasing maintenance of physical activity upon the completion of a supervised exercise program. Motivational interviews will occur at the end of the structured program and at 3 months post program completion. Outcomes will be collected at 6 months post-program.



Primary Outcome Measures :
  1. Change in physical activity as measured by the GODIN physical activity questionnaire [ Time Frame: baseline, 3, 6 months post program ]

Secondary Outcome Measures :
  1. Change in Hemoglobin A1C, BMI, six minute walk-test, QoL, and self-efficacy. [ Time Frame: Baseline, 3, 6 months post-program ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a) self-reported physician diagnosed T2D, included are those who are treated with diet alone, oral medication and insulin
  • b) clearance by Living Well clinical staff to exercise through GXT algorithm and triaged to "Keep Going" level class,
  • c) at least 18 years of age,
  • d) ability to read and write in English.

Exclusion Criteria:

  • a) insulin therapy that began less than 2 years after T2D diagnosis,
  • b) changes during the previous 2 months in oral hypoglycemic

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01067924


Locations
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada
Sponsors and Collaborators
University of Calgary
Investigators
Principal Investigator: Ronald Sigal University of Calgary

Responsible Party: Marni Armstrong, PhD student, University of Calgary
ClinicalTrials.gov Identifier: NCT01067924     History of Changes
Other Study ID Numbers: 22490
First Posted: February 12, 2010    Key Record Dates
Last Update Posted: July 21, 2014
Last Verified: July 2014

Keywords provided by Marni Armstrong, University of Calgary:
Type 2 diabetes, motivational interviewing, physical activity maintenance, physical activity adherence

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases