Type 2 DiabetesPhase 2NCT00221234
Alberta Diabetes and Physical Activity Trial
A Phase 2 study testing Print materials, pedometers/logbooks and Print materials, pedometers/logbooks, telephone counselling in people with Type 2 Diabetes, run by University of Alberta.
Trial summary
This project will assess the incremental and cumulative impact of three behavioural intervention strategies for the promotion of physical activity in the adult general population with Type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Print materials, pedometers/logbooks and Print materials, pedometers/logbooks, telephone counselling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Jul 2007
- Phase
- Phase 2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 years old, Type 2 Diabetes, Living in the province of Alberta, Can communicate in English.
Who cannot join
- Serious Contraindications to Physical Activity
About this study
Official title: The Development and Evaluation of Physical Activity Behavioural Strategies for Adults With Type 2 Diabetes: A Population Based Approach
This project will assess the incremental and cumulative impact of three behavioural intervention strategies for the promotion of physical activity in the adult general population with Type 2 diabetes.
Read the detailed description
An increasing prevalence of Type 2 Diabetes is associated with the aging population, a significant rise in the prevalence of obesity, and a sedentary lifestyle. In Canada, 4.9-7.0% over the age of 12 and 17% over the age of 64 are estimated to have diabetes, 90-95% of which will be Type 2. Strong evidence supports the importance of physical activity in the management of Type 2 Diabetes. However, current literature lacks clear understanding of best strategies for physical activity behaviour change in this target population. Existing studies employ resource intensive, one-to-one individual and clinically-based approaches with limited theoretical grounding for recommended health behaviour change. Most fail to offer practical, sustainable, economically viable solutions, with documented long-term intervention efficacy. The call to move beyond the clinical focus by including theoretically population-based and "real-life" approaches for the management Type 2 Diabetes remains largely unheeded. The three interventions are: (1) standard print-based physical activity educational materials provided by the Canadian Diabetes Association (CDA); (2) CDA materials + pedometers and a log book + theoretical stage-matched print-based physical activity materials; and, (3) the same as intervention 2 with the addition of a 12-month physical activity telephone counseling protocol.
- Conditions
- Type 2 Diabetes
- Being tested
- Print materials, pedometers/logbooks, Print materials, pedometers/logbooks, telephone counselling
- Keywords
- Diabetes, Physical Activity
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Print materials, pedometers/logbooksBehavioural
Print materials, pedometers/logbooks, telephone counsellingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Behaviour
Secondary outcomes (1)
HbA1c, CRP, lipid concentrations, fasting blood glucose, insulin, health related quality of life, psychosocial predictors of physical activity.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2005
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Investigators
- Ron C Plotnikoff, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221234
- Sponsor's protocol ID
- MOP-69070
- Status last verified
- Nov 2024
- First submitted
- 13 Sep 2005
- Last updated
- 5 Nov 2024
- Results posted
- No
Publications
Plotnikoff RC, Karunamuni N, Courneya KS, Sigal RJ, Johnson JA, Johnson ST. The Alberta Diabetes and Physical Activity Trial (ADAPT): a randomized trial evaluating theory-based interventions to increase physical activity in adults with type 2 diabetes. Ann Behav Med. 2013 Feb;45(1):45-56. doi: 10.1007/s12160-012-9405-2.
PubMed 22922954Plotnikoff RC, Courneya KS, Sigal RJ, Johnson JA, Birkett N, Lau D, Raine K, Johnson ST, Karunamuni N. Alberta Diabetes and Physical Activity Trial (ADAPT): a randomized theory-based efficacy trial for adults with type 2 diabetes--rationale, design, recruitment, evaluation, and dissemination. Trials. 2010 Jan 12;11:4. doi: 10.1186/1745-6215-11-4.
PubMed 20067626
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Evaluation of Physical Activity Behavioural Strategies for Adults With Type 2 Diabetes: A Population Based Approach
- ClinicalTrials.gov ID
- NCT00221234
- Acronym / sponsor ID
- MOP-69070
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes, Physical Activity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- Jul 2007 (actual)
- First posted
- 22 Sep 2005 (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.
This project will assess the incremental and cumulative impact of three behavioural intervention strategies for the promotion of physical activity in the adult general population with Type 2 diabetes.
Detailed description
An increasing prevalence of Type 2 Diabetes is associated with the aging population, a significant rise in the prevalence of obesity, and a sedentary lifestyle. In Canada, 4.9-7.0% over the age of 12 and 17% over the age of 64 are estimated to have diabetes, 90-95% of which will be Type 2. Strong evidence supports the importance of physical activity in the management of Type 2 Diabetes. However, current literature lacks clear understanding of best strategies for physical activity behaviour change in this target population. Existing studies employ resource intensive, one-to-one individual and clinically-based approaches with limited theoretical grounding for recommended health behaviour change. Most fail to offer practical, sustainable, economically viable solutions, with documented long-term intervention efficacy. The call to move beyond the clinical focus by including theoretically population-based and "real-life" approaches for the management Type 2 Diabetes remains largely unheeded. The three interventions are: (1) standard print-based physical activity educational materials provided by the Canadian Diabetes Association (CDA); (2) CDA materials + pedometers and a log book + theoretical stage-matched print-based physical activity materials; and, (3) the same as intervention 2 with the addition of a 12-month physical activity telephone counseling protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- >18 years old, Type 2 Diabetes, Living in the province of Alberta, Can communicate in English.
Key exclusion criteria (1 listed)
- Serious Contraindications to Physical Activity
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 |
|---|---|---|
| Print materials, pedometers/logbooks | Behavioural | – |
| Print materials, pedometers/logbooks, telephone counselling | Behavioural | – |
Primary outcome
Physical Activity Behaviour
1 secondary outcome
HbA1c, CRP, lipid concentrations, fasting blood glucose, insulin, health related quality of life, psychosocial predictors of physical activity.
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 5 Nov 2024.
- Derived from this study: PubMed 22922954Plotnikoff RC, Karunamuni N, Courneya KS, Sigal RJ, Johnson JA, Johnson ST. The Alberta Diabetes and Physical Activity Trial (ADAPT): a randomized trial evaluating theory-based interventions to increase physical activity in adults with type 2 diabetes. Ann Behav Med. 2013 Feb;45(1):45-56. doi: 10.1007/s12160-012-9405-2.
- Derived from this study: PubMed 20067626Plotnikoff RC, Courneya KS, Sigal RJ, Johnson JA, Birkett N, Lau D, Raine K, Johnson ST, Karunamuni N. Alberta Diabetes and Physical Activity Trial (ADAPT): a randomized theory-based efficacy trial for adults with type 2 diabetes--rationale, design, recruitment, evaluation, and dissemination. Trials. 2010 Jan 12;11:4. doi: 10.1186/1745-6215-11-4.
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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.
Ron C Plotnikoff, PhD principal investigator
University of Alberta
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Print materials, pedometers/logbooks and Print materials, pedometers/logbooks, telephone counselling in people with Type 2 Diabetes, run by University of Alberta.
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 1 inclusion and 1 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 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Physical Activity Behaviour. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00221234, which also lists 2 linked publications.
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 5 Nov 2024.