PrediabetesNCT05412264
Step Up For Health Study: A Pedometer and Website Intervention in Those With Prediabetes
A study testing Website intervention in people with Prediabetes and Impaired Glucose Tolerance, run by University of Alberta at 1 site in Canada.
Trial summary
This study will examine whether a physical activity program, specifically increasing walking steps, offered over the internet is able to increase physical activity in adults with prediabetes. The study will take place over 12 weeks. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prediabetes, Impaired Glucose Tolerance
- What is being tested?
- Website intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to 20 Jul 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- You are over 18 years of age.
- Have been told you have prediabetes by a health professional.
- You are free from any medical problems that make it hard to be active. For example, congestive heart failure, a recent knee or hip replacement, or you need to use a cane or walker to help you walk.
- Live in Alberta.
- Are interested in finding ways to become more physically active.
- Are interested in wearing a pedometer and tracking your daily steps.
Who cannot join
- You have been told you have type 2 diabetes.
- You do not confirm on the website that it is safe for you to increase your walking or other physical activities.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Alberta Health Services, Nutrition Services
Edmonton, Alberta, T1B 0E1
About this study
Official title: Step Up for Health: A Pedometer-based Randomized Controlled Trial for Individuals at High Risk for Type 2 Diabetes
This study will examine whether a physical activity program, specifically increasing walking steps, offered over the internet is able to increase physical activity in adults with prediabetes. The study will take place over 12 weeks. The investigators want to see if people who receive the intervention increase their physical activity more than people who do not receive the intervention. The physical activity program will include using a pedometer to track daily step counts online, set weekly goals, and receive motivational messages delivered weekly using email. The investigators are also going to collect data on waist circumference, body weight and quality of life at baseline, 12 weeks and 16 weeks after the intervention has completed to see if these change over the course of the study. The investigators will be recruiting 200 adults who have attended the Edmonton, Alberta prediabetes education class offered by Alberta Health Services, Nutrition Services and report they have prediabetes. If able to successfully increase physical activity, this study will identify a web and home-based intervention that can be offered to individuals who participate in lifestyle programs delivered in primary care settings (e.g., Edmonton prediabetes program) in both rural and urban locations.
Read the detailed description
Relevance to diabetes: Without intervention, most people at high-risk of diabetes (e.g., with prediabetes) will eventually develop type 2 diabetes over time. Moderate physical activity of 150 minutes per week has been demonstrated to improve glucose tolerance and decrease type 2 diabetes risk. Research is needed to determine the effectiveness and acceptability of web-based methods of increasing physical activity, specifically walking, in these high risk populations.
Brief background of the issue: Studies completed in adults with prediabetes have demonstrated lower physical activity levels than the general population; however, adults with prediabetes have reported they are interested in a physical activity program that is focused on individuals with prediabetes.
Objective: To determine if a theoretically-based physical activity internet website with pedometer step and physical activity monitoring is able to increase physical activity behavior among adults at high risk of type 2 diabetes.
Hypothesis: Individuals at high risk of type 2 diabetes randomized to the intervention group will increase their pedometer steps and physical activity over a 12-week intervention compared to individuals in the control group.
Methods: Four hundred adults at high risk of type 2 diabetes will be recruited from the Edmonton and Calgary prediabetes education classes by Registered Dietitians (RD) teaching the class. The RD will discuss the study and interested participants will receive a pedometer, waist circumference tape and study information letter at the class. In the study information letter they will be directed to a website where they can agree to participate in the study after completing a brief questionnaire to determine study eligibility and a Physical activity readiness (e-ParMedX) form to determine physical activity safety. After completing these documents, if they are eligible to participate they will complete an online baseline questionnaire, a 3-day pedometer step test and a waist circumference measurement. All measurements and personal information will be recorded on the secure website. These measurements will be repeated at 12 weeks and 16 weeks post intervention. Upon completion of the baseline measures, they will be randomized by the website program into either the control or intervention group. The intervention group will receive a theoretically-based 12-week intervention program via the website designed to increase their physical activity and steps. The website content is based on the theory of planned behaviour and tailored to people at high-risk of type 2 diabetes. Participants will receive weekly information that is temporally sequenced on the website for each of the 12 weeks, set weekly goals and record their daily steps on the website. After the control group has completed their six-month assessment they will also be able to access the 12 week intervention.
Application to Practice: If able to successfully increase physical activity, this trial will identify a theoretically-based web and home-based intervention that can be offered to individuals who participate in lifestyle programs delivered in primary care settings (e.g., Edmonton prediabetes program) in both rural and urban locations. Research is needed to determine the effectiveness and acceptability of web-based methods of increasing physical activity, specifically walking, in these high-risk populations.
- Conditions
- Prediabetes, Impaired Glucose Tolerance
- Being tested
- Website intervention
- Keywords
- Prediabetes, Pedometer, Web-based
- Medical subject headings
- Prediabetic State, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Website interventionBehavioural
12 week motivational emails, recording pedometer steps and waist circumference
| Study group | Role | What they receive |
|---|---|---|
| Website intervention | Experimental | Website access: 12 Weekly emails, access to website with goal setting and recording steps Receives: Behavioral: Website intervention |
| Delayed access | No intervention | Will not receive access to the program/website until they complete their 16 week assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased pedometer steps
Measured as a 3-day step test
Measured: 12 weeks
Increased pedometer steps
Measured as a 3-day step test
Measured: 16 weeks
Secondary outcomes (2)
Waist circumference
Measured
Measured: 12 weeks
Waist circumference
Measured
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study startJan 2014
- Primary completion5 Oct 2016
- Study completion20 Jul 2021
Why it stopped: REB Approval lapsed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Athabasca University, Alberta Health services
- Responsible party
- Sponsor
- Investigators
- Jeffrey Vallance, PhD, Principal investigator, Athabasca UniversityLorian Taylor, PhD, Principal investigator, Alberta Health services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412264
- Sponsor's protocol ID
- Pro00039828
- Status last verified
- May 2022
- First submitted
- 21 Jan 2015
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Step Up for Health: A Pedometer-based Randomized Controlled Trial for Individuals at High Risk for Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05412264
- Acronym / sponsor ID
- Pro00039828
- Conditions
- Prediabetes, Impaired Glucose Tolerance
- Keywords
- Prediabetes, Pedometer, Web-based
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: REB Approval lapsed.
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Athabasca University, Alberta Health services
- Study start
- Jan 2014
- Primary completion
- 5 Oct 2016 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 9 Jun 2022 (actual)
- 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 study will examine whether a physical activity program, specifically increasing walking steps, offered over the internet is able to increase physical activity in adults with prediabetes. The study will take place over 12 weeks. The investigators want to see if people who receive the intervention increase their physical activity more than people who do not receive the intervention. The physical activity program will include using a pedometer to track daily step counts online, set weekly goals, and receive motivational messages delivered weekly using email. The investigators are also going to collect data on waist circumference, body weight and quality of life at baseline, 12 weeks and 16 weeks after the intervention has completed to see if these change over the course of the study. The investigators will be recruiting 200 adults who have attended the Edmonton, Alberta prediabetes education class offered by Alberta Health Services, Nutrition Services and report they have prediabetes. If able to successfully increase physical activity, this study will identify a web and home-based intervention that can be offered to individuals who participate in lifestyle programs delivered in primary care settings (e.g., Edmonton prediabetes program) in both rural and urban locations.
Detailed description
Relevance to diabetes: Without intervention, most people at high-risk of diabetes (e.g., with prediabetes) will eventually develop type 2 diabetes over time. Moderate physical activity of 150 minutes per week has been demonstrated to improve glucose tolerance and decrease type 2 diabetes risk. Research is needed to determine the effectiveness and acceptability of web-based methods of increasing physical activity, specifically walking, in these high risk populations.
Brief background of the issue: Studies completed in adults with prediabetes have demonstrated lower physical activity levels than the general population; however, adults with prediabetes have reported they are interested in a physical activity program that is focused on individuals with prediabetes.
Objective: To determine if a theoretically-based physical activity internet website with pedometer step and physical activity monitoring is able to increase physical activity behavior among adults at high risk of type 2 diabetes.
Hypothesis: Individuals at high risk of type 2 diabetes randomized to the intervention group will increase their pedometer steps and physical activity over a 12-week intervention compared to individuals in the control group.
Methods: Four hundred adults at high risk of type 2 diabetes will be recruited from the Edmonton and Calgary prediabetes education classes by Registered Dietitians (RD) teaching the class. The RD will discuss the study and interested participants will receive a pedometer, waist circumference tape and study information letter at the class. In the study information letter they will be directed to a website where they can agree to participate in the study after completing a brief questionnaire to determine study eligibility and a Physical activity readiness (e-ParMedX) form to determine physical activity safety. After completing these documents, if they are eligible to participate they will complete an online baseline questionnaire, a 3-day pedometer step test and a waist circumference measurement. All measurements and personal information will be recorded on the secure website. These measurements will be repeated at 12 weeks and 16 weeks post intervention. Upon completion of the baseline measures, they will be randomized by the website program into either the control or intervention group. The intervention group will receive a theoretically-based 12-week intervention program via the website designed to increase their physical activity and steps. The website content is based on the theory of planned behaviour and tailored to people at high-risk of type 2 diabetes. Participants will receive weekly information that is temporally sequenced on the website for each of the 12 weeks, set weekly goals and record their daily steps on the website. After the control group has completed their six-month assessment they will also be able to access the 12 week intervention.
Application to Practice: If able to successfully increase physical activity, this trial will identify a theoretically-based web and home-based intervention that can be offered to individuals who participate in lifestyle programs delivered in primary care settings (e.g., Edmonton prediabetes program) in both rural and urban locations. Research is needed to determine the effectiveness and acceptability of web-based methods of increasing physical activity, specifically walking, in these high-risk populations.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Website intervention | Experimental | Behavioral: Website interventionWebsite access: 12 Weekly emails, access to website with goal setting and recording steps |
| Delayed access | No intervention | –Will not receive access to the program/website until they complete their 16 week assessments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- You are over 18 years of age.
- Have been told you have prediabetes by a health professional.
- You are free from any medical problems that make it hard to be active. For example, congestive heart failure, a recent knee or hip replacement, or you need to use a cane or walker to help you walk.
- Live in Alberta.
- Are interested in finding ways to become more physically active.
Key exclusion criteria (2 listed)
- You have been told you have type 2 diabetes.
- You do not confirm on the website that it is safe for you to increase your walking or other physical activities.
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 |
|---|---|---|
| Website intervention12 week motivational emails, recording pedometer steps and waist circumference | Behavioural | Website intervention |
Primary outcome
Increased pedometer steps
Time frame: 12 weeks
Measured as a 3-day step test
Increased pedometer steps
Time frame: 16 weeks
Measured as a 3-day step test
2 secondary outcomes
Waist circumference
Time frame: 12 weeks
Waist circumference
Time frame: 16 weeks
Results and safety
The study was stopped early (reason given: REB Approval lapsed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
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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.
Jeffrey Vallance, PhD principal investigator
Athabasca University
Lorian Taylor, PhD principal investigator
Alberta Health services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Website intervention in people with Prediabetes and Impaired Glucose Tolerance, run by University of Alberta 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 6 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: stopped early, as of the sponsor's last update on 5 Jul 2022. 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 was stopped early (reason given: REB Approval lapsed.). Results are not available in the source record.
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?
Increased pedometer steps (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 5 Jul 2022; AzTrials last refreshed its copy on 29 Oct 2026.