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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01067924
• Other study ID #: 22490
• Status: Completed
• Phase: N/A
• First received: February 10, 2010
• Last updated: July 17, 2014
• Start date: September 2009
• Est. completion date: August 2013

Study information

• Verified date: July 2014
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: August 2013
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in physical activity as measured by the GODIN physical activity questionnaire		baseline, 3, 6 months post program	No
Secondary	Change in Hemoglobin A1C, BMI, six minute walk-test, QoL, and self-efficacy.		Baseline, 3, 6 months post-program	No