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

Primary Purpose

Prediabetes, Impaired Glucose Tolerance

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Website intervention
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Prediabetes focused on measuring Prediabetes, Pedometer, Web-based

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Alberta Health Services, Nutrition Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Website intervention

Delayed access

Arm Description

Website access: 12 Weekly emails, access to website with goal setting and recording steps

Will not receive access to the program/website until they complete their 16 week assessments

Outcomes

Primary Outcome Measures

Increased pedometer steps
Measured as a 3-day step test
Increased pedometer steps
Measured as a 3-day step test

Secondary Outcome Measures

Waist circumference
Measured
Waist circumference
Measured

Full Information

First Posted
January 21, 2015
Last Updated
June 29, 2022
Sponsor
University of Alberta
Collaborators
Athabasca University, Alberta Health services
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1. Study Identification

Unique Protocol Identification Number
NCT05412264
Brief Title
Step Up For Health Study: A Pedometer and Website Intervention in Those With Prediabetes
Official Title
Step Up for Health: A Pedometer-based Randomized Controlled Trial for Individuals at High Risk for Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
REB Approval lapsed.
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 5, 2016 (Actual)
Study Completion Date
July 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Athabasca University, Alberta Health services

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes, Impaired Glucose Tolerance
Keywords
Prediabetes, Pedometer, Web-based

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Website intervention
Arm Type
Experimental
Arm Description
Website access: 12 Weekly emails, access to website with goal setting and recording steps
Arm Title
Delayed access
Arm Type
No Intervention
Arm Description
Will not receive access to the program/website until they complete their 16 week assessments
Intervention Type
Behavioral
Intervention Name(s)
Website intervention
Intervention Description
12 week motivational emails, recording pedometer steps and waist circumference
Primary Outcome Measure Information:
Title
Increased pedometer steps
Description
Measured as a 3-day step test
Time Frame
12 weeks
Title
Increased pedometer steps
Description
Measured as a 3-day step test
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Waist circumference
Description
Measured
Time Frame
12 weeks
Title
Waist circumference
Description
Measured
Time Frame
16 weeks
Other Pre-specified Outcome Measures:
Title
Questionnaire
Description
Measuring changes in attitude, social norms and perceived behavioral control
Time Frame
12 weeks
Title
Questionnaire
Description
Measuring changes in attitude, social norms and perceived behavioral control
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Vallance, PhD
Organizational Affiliation
Athabasca University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lorian Taylor, PhD
Organizational Affiliation
Alberta Health services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alberta Health Services, Nutrition Services
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T1B 0E1
Country
Canada

12. IPD Sharing Statement

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

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