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OpenTrials
Completed

NCT Number: NCT01067924

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary

Calgary, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational Interviewing

Behavioral

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 outcomes

  1. Change in physical activity as measured by the GODIN physical activity questionnaire

    Time frame: baseline, 3, 6 months post program

Secondary outcomes

  1. Change in Hemoglobin A1C, BMI, six minute walk-test, QoL, and self-efficacy.

    Time frame: Baseline, 3, 6 months post-program

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Feb 12, 2010
Registry last updated
Jul 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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