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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Motivational interviewing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motivational interviewing<br> | Behavioral: Motivational interviewing<br>* 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.<br>|
| Active Comparator: Standard of care<br> | Behavioral: Motivational interviewing<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical activity as measured by the GODIN physical activity questionnaire |  | baseline, 3, 6 months post program | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin A1C, BMI, six minute walk-test, QoL, and self-efficacy. |  | Baseline, 3, 6 months post-program | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, motivational interviewing, physical activity maintenance, physical activity adherence