Motivational Interviewing to Promote Maintenance of Physical Activity in People With Type 2 Diabetes
1 other identifier
interventional
55
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable type-2-diabetes
Started Sep 2009
Longer than P75 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 10, 2010
CompletedFirst Posted
Study publicly available on registry
February 12, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedJuly 21, 2014
July 1, 2014
2.6 years
February 10, 2010
July 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in physical activity as measured by the GODIN physical activity questionnaire
baseline, 3, 6 months post program
Secondary Outcomes (1)
Change in Hemoglobin A1C, BMI, six minute walk-test, QoL, and self-efficacy.
Baseline, 3, 6 months post-program
Study Arms (2)
Motivational interviewing
EXPERIMENTALStandard of care
ACTIVE COMPARATORInterventions
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 Criteria
You may qualify if:
- 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.
You may not qualify if:
- a) insulin therapy that began less than 2 years after T2D diagnosis,
- b) changes during the previous 2 months in oral hypoglycemic
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Calgary
Calgary, Alberta, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald Sigal
University of Calgary
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD student
Study Record Dates
First Submitted
February 10, 2010
First Posted
February 12, 2010
Study Start
September 1, 2009
Primary Completion
April 1, 2012
Study Completion
August 1, 2013
Last Updated
July 21, 2014
Record last verified: 2014-07