"Increasing Physical Activity in Canadian Adults Affected by COVID-19 Social Distancing Restrictions: A Feasibility Trial of an Online Intervention"

NCT04400305 | Completed

• 1 other identifier: 05-281983
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief Summary

Internet-based health promotion programs have the potential to reach more individuals than in person interventions, without overtaxing healthcare resources. Having a high quality, user-centered web-based program can help maximize user engagement and adherence. Thus, the primary objective of this pilot study is to examine the feasibility, time, cost, and acceptability of a web-based physical activity behavior change program with Canadian Adults who have had to start practising/following the social distancing guidelines due to the COVID-19 situation. We will also be examining changes other behavioral indicators related to PA as a secondary outcome measure.

Conditions

Physical Activity, Healthy Promotion

Outcome Measures

Primary Outcomes (3)

• Recruitment rate (monthly)

  For the full scale RCT, we are looking for a 1 day per week or 30 min MVPA change which equates to an approximate effect size of d = .35. This equates to roughly 65 per group (130 for a two group trial). If we recruit for 2 years in the large trial (assuming a six month time period for each person in the intervention) we need to be recruiting at least 6 per month.

  4 months

• Participant retention

  Number of participants who complete both baseline and end of study (6 week) measures. A 80-100% retention rate is indicative of a strong trial (Jackson \& Waters, 2005).

  6 weeks

• Participant intervention satisfaction/evaluation

  For satisfaction ratings, mean and standard deviations will be calculated for the quantitative satisfaction and evaluation questionnaire. Given that scores of 1 (ex. not helpful, did not use the tools) and 2 (ex. Somewhat helpful, used a little bit of the tools) indicated levels of dissatisfaction, and 3 (ex. Quite helpful, used a bit of the tools) and 4 (ex. Extremely helpful, used a lot of the tools) indicated some sort of satisfaction, a mean score of ≥ 2.5 will be deemed acceptable for recommendation for a full RCT.

  6 Weeks

Secondary Outcomes (6)

• Change in self-reported physical activity from baseline to 6 weeks

  6 Weeks

• Change in physical activity beliefs, attitudes, barriers, and motivation from baseline to 6 weeks.

  Baseline - 6 weeks

• Change in physical activity behaviour regulation from baseline to 6 weeks.

  Baseline - 6 weeks

• Change in physical activity habits from baseline to 6 weeks

  Baseline - 6 weeks

• Change in physical activity identity from baseline to 6 weeks

  Baseline - 6 weeks

Study Arms (2)

Control

NO INTERVENTION

No Intervention: Control Group This group will complete baseline and final questionnaires (online). At the end of the study this group will have the option to receive access to the other group's materials (online platform) if they wish, for the 6 week period following the study.

Intervention

OTHER

Participants will complete a baseline questionnaire, and receive access to the our online platform for 6 weeks. Completing the online platform is designed to encourage participants to engage in physical activity. At 3 weeks, a check-in session will occur over the phone. At 6 weeks the participant will be contacted to complete the final questionnaire, and do a wrap up interview. The end-of-trial qualitative interview will evaluate participant satisfaction and feasibility of the intervention. For this reason a lab employee unaffiliated with this study will complete these in person interviews.

Behavioral: Digital Health Online Platform

Interventions

Digital Health Online Platform BEHAVIORAL

The website has 10 lessons that the participant will gain access to on a bi-weekly basis. Lesson titles are as follows: Lesson 1 - Benefits of Physical Activity on Chronic Disease Lesson 2 - Mental benefits of Physical Activities Lesson 3 - Increasing Self Confidence for Physical Activities Lesson 4 - Learning about your Emotions Lesson 5 - Building Social Support Lesson 6 - Building Physical Activity Opportunity Lesson 7 - Goal Setting and Planning Lesson 8 - Self Monitoring Lesson 9 - Habit Lesson 10 - Identity

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Potential participants will be included if they have:
• started practising social distancing due to the current COVID-19 guidelines
• are currently not meeting the physical activity (PA) guidelines (less than 150 minutes of moderate to vigorous aerobic activity)
• participants must have access to the internet at home, and have a smart phone or home computer that can support the eHealth application we are using.

You may not qualify if:

• Participants will be excluded from the project if:
• they do not have access to the Internet,
• are unable to speak/read English,
• are engaging in moderate-to vigorous PA (MVPA) sufficient to meet the PA Guidelines,
• have an existing chronic medical condition potentially making them at risk of injury or ill health from increasing their physical activity (this will be assessed using the GAQ. Screening completed formally over the phone, and participants will give their consent online)

Sponsors & Collaborators

• University of Victoria: lead

Study Sites (2)

Behavioural Medicine Lab, University of Victoria

Victoria, British Columbia, V8P-5C2, Canada

Location

University of Victoria

Victoria, British Columbia, V8W 2Y2, Canada

Location

Related Publications (1)

• Jackson N, Waters E; Guidelines for Systematic Reviews in Health Promotion and Public Health Taskforce. Criteria for the systematic review of health promotion and public health interventions. Health Promot Int. 2005 Dec;20(4):367-74. doi: 10.1093/heapro/dai022. Epub 2005 Sep 16.

  PMID: 16169885 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Ryan Rhodes

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 22, 2020
• Study Start: May 20, 2020
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)