Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Marni Armstrong, University of Calgary
ClinicalTrials.gov Identifier:
NCT01067924
First received: February 10, 2010
Last updated: February 14, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention
Type 2 Diabetes
 Behavioral: Motivational interviewing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Motivational Interviewing to Promote Maintenance of Physical Activity in People With Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Change in physical activity as measured by the GODIN physical activity questionnaire [ Time Frame: baseline, 3, 6 months post program ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Hemoglobin A1C, BMI, six minute walk-test, QoL, and self-efficacy. [ Time Frame: Baseline, 3, 6 months post-program ] [ Designated as safety issue: No ]

Estimated Enrollment: 55
Study Start Date: September 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01067924

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

No publications provided

Responsible Party: Marni Armstrong, PhD student, University of Calgary
ClinicalTrials.gov Identifier: NCT01067924     History of Changes
Other Study ID Numbers: 22490
Study First Received: February 10, 2010
Last Updated: February 14, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on May 16, 2013