NCT05412264

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2016

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2021

Completed
11 months until next milestone

First Posted

Study publicly available on registry

June 9, 2022

Completed
Last Updated

July 5, 2022

Status Verified

May 1, 2022

Enrollment Period

2.8 years

First QC Date

January 21, 2015

Last Update Submit

June 29, 2022

Conditions

PrediabetesImpaired Glucose Tolerance

Keywords

PrediabetesPedometerWeb-based

Outcome Measures

Primary Outcomes (2)

  • Increased pedometer steps

    Measured as a 3-day step test

    12 weeks

  • Increased pedometer steps

    Measured as a 3-day step test

    16 weeks

Secondary Outcomes (2)

  • Waist circumference

    12 weeks

  • Waist circumference

    16 weeks

Other Outcomes (2)

  • Questionnaire

    12 weeks

  • Questionnaire

    16 weeks

Study Arms (2)

Website intervention

EXPERIMENTAL

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

Behavioral: Website intervention

Delayed access

NO INTERVENTION

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

Interventions

Website interventionBEHAVIORAL

12 week motivational emails, recording pedometer steps and waist circumference

Website intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alberta Health Services, Nutrition Services

Edmonton, Alberta, T1B 0E1, Canada

Location

MeSH Terms

Conditions

Prediabetic StateGlucose Intolerance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemia

Study Officials

  • Jeffrey Vallance, PhD

    Athabasca University

    PRINCIPAL INVESTIGATOR

  • Lorian Taylor, PhD

    Alberta Health services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2015

First Posted

June 9, 2022

Study Start

January 1, 2014

Primary Completion

October 5, 2016

Study Completion

July 20, 2021

Last Updated

July 5, 2022

Record last verified: 2022-05

Locations

CA(1)