Step Up For Health Study: A Pedometer and Website Intervention in Those With Prediabetes

June 29, 2022 updated by: University of Alberta

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T1B 0E1
        • Alberta Health Services, Nutrition Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Website intervention
Website access: 12 Weekly emails, access to website with goal setting and recording steps
Behavioral: Website intervention
12 week motivational emails, recording pedometer steps and waist circumference
No Intervention: Delayed access
Will not receive access to the program/website until they complete their 16 week assessments

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Increased pedometer steps
Time Frame: 12 weeks
Measured as a 3-day step test
12 weeks
Increased pedometer steps
Time Frame: 16 weeks
Measured as a 3-day step test
16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Waist circumference
Time Frame: 12 weeks
Measured
12 weeks
Waist circumference
Time Frame: 16 weeks
Measured
16 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Questionnaire
Time Frame: 12 weeks
Measuring changes in attitude, social norms and perceived behavioral control
12 weeks
Questionnaire
Time Frame: 16 weeks
Measuring changes in attitude, social norms and perceived behavioral control
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alberta

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Alberta Health services
Athabasca University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jeffrey Vallance, PhD, Athabasca University
  • Principal Investigator: Lorian Taylor, PhD, Alberta Health Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 5, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 20, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00039828

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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