Type 2 DiabetesNCT01067924
Motivational Interviewing to Promote Maintenance of Physical Activity in People With Type 2 Diabetes
A study testing Motivational interviewing in people with Type 2 Diabetes, run by University of Calgary at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2009to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- a) insulin therapy that began less than 2 years after T2D diagnosis,
- b) changes during the previous 2 months in oral hypoglycemic
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Motivational interviewing
- Keywords
- Type 2 diabetes, motivational interviewing, physical activity maintenance, physical activity adherence
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Motivational interviewing | Experimental | Not described Receives: Behavioral: Motivational interviewing |
| Standard of care | Active comparator | Not described Receives: Behavioral: Motivational interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity as measured by the GODIN physical activity questionnaire
Measured: baseline, 3, 6 months post program
Secondary outcomes (1)
Change in Hemoglobin A1C, BMI, six minute walk-test, QoL, and self-efficacy.
Measured: Baseline, 3, 6 months post-program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startSep 2009
- Primary completionApr 2012
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marni Armstrong, University of Calgary
- Investigators
- Ronald Sigal, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067924
- Sponsor's protocol ID
- 22490
- Status last verified
- Jul 2014
- First submitted
- 10 Feb 2010
- Last updated
- 21 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing to Promote Maintenance of Physical Activity in People With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01067924
- Acronym / sponsor ID
- 22490
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, motivational interviewing, physical activity maintenance, physical activity adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 12 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational interviewing | Experimental | Behavioral: Motivational interviewing |
| Standard of care | Active comparator | Behavioral: Motivational interviewing |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- a) insulin therapy that began less than 2 years after T2D diagnosis,
- b) changes during the previous 2 months in oral hypoglycemic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interviewingIntervention 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. | Behavioural | Motivational interviewing, Standard of care |
Primary outcome
Change in physical activity as measured by the GODIN physical activity questionnaire
Time frame: baseline, 3, 6 months post program
1 secondary outcome
Change in Hemoglobin A1C, BMI, six minute walk-test, QoL, and self-efficacy.
Time frame: Baseline, 3, 6 months post-program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2014.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Sigal principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing in people with Type 2 Diabetes, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical activity as measured by the GODIN physical activity questionnaire (time frame: baseline, 3, 6 months post program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2014.