NCT01067924

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

July 21, 2014

Status Verified

July 1, 2014

Enrollment Period

2.6 years

First QC Date

February 10, 2010

Last Update Submit

July 17, 2014

Conditions

Keywords

Type 2 diabetes, motivational interviewing, physical activity maintenance, physical activity adherence

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

EXPERIMENTAL
Behavioral: Motivational interviewing

Standard of care

ACTIVE COMPARATOR
Behavioral: Motivational interviewing

Interventions

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.

Motivational interviewingStandard of care

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Ronald Sigal

    University of Calgary

    PRINCIPAL INVESTIGATOR

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

Locations