Physical Activity, Healthy Promotion Clinical Trial
— COVID-19Official title:
"Increasing Physical Activity in Canadian Adults Who Have Been Affected by COVID-19 Social Distancing Restrictions: A Feasibility Trial of an Online Intervention"
| NCT number | NCT04400305 |
| Other study ID # | 05-281983 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 20, 2020 |
| Est. completion date | August 30, 2021 |
| Verified date | October 2021 |
| Source | University of Victoria |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 37 |
| Est. completion date | August 30, 2021 |
| Est. primary completion date | August 30, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: Potential participants will be included if they have: 1. started practising social distancing due to the current COVID-19 guidelines 2. are currently not meeting the physical activity (PA) guidelines (less than 150 minutes of moderate to vigorous aerobic activity) 3. 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. Exclusion Criteria: Participants will be excluded from the project if: 1. they do not have access to the Internet, 2. are unable to speak/read English, 3. are engaging in moderate-to vigorous PA (MVPA) sufficient to meet the PA Guidelines, 4. 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) |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Behavioural Medicine Lab, University of Victoria | Victoria | British Columbia |
| Canada | University of Victoria | Victoria | British Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| University of Victoria |
Canada,
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. Epub 2005 Sep 16. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | Change in self-reported physical activity from baseline to 6 weeks | Measured from questionnaire using Godin's personal self report leisure time measurement tool, also known as the Leisure Score Index (LSI). The Leisure Score Index contains three questions, which assess the frequency of mild, moderate, and strenuous activity performed for at least 10 minutes during free time in a typical week. Changes in these measures will be examined | 6 Weeks | |
| Secondary | Change in physical activity beliefs, attitudes, barriers, and motivation from baseline to 6 weeks. | Included in questionnaire - Ajzen's theory of planned behaviour questionnaire will be applied to measure participants' beliefs, attitudes, barriers, and motivation related to physical activity. | Baseline - 6 weeks | |
| Secondary | Change in physical activity behaviour regulation from baseline to 6 weeks. | Included in questionnaire - 5 items adapted from Umstattd's scale measuring physical activity self-regulation strategies. Changes in this measure will be examined. The Behavioural Regulation in Exercise Questionnaire - 5 point Likert Scale 1 = Strongly agree to 5 = Strongly Disagree | Baseline - 6 weeks | |
| Secondary | Change in physical activity habits from baseline to 6 weeks | Included in questionnaire - 12 Self Report Habit Index items from the measure developed by Verplanken and Orbell and adapted to physical activity by Chatzisarantis and Hagger. Changes in this measure will be examined. Physical Activity Participation Habits Questionnaire - Habit Index - 5 point Likert Scale 1 = Strongly agree to 5 = Strongly Disagree | Baseline - 6 weeks | |
| Secondary | Change in physical activity identity from baseline to 6 weeks | Included in questionnaire - Anderson and Cychosz Exercise Identity Scale is used to measure participants' identification as someone who participates in physical activity. Physical Activity Participation Identity Questionnaire - Identity Scale - 5 point Likert Scale 1 = Strongly agree to 5 = Strongly Disagree | Baseline - 6 weeks | |
| Secondary | Change in life satisfaction measured using the Short Form 12 questionnaire from baseline to 6 weeks | Change in life satisfaction from baseline to 6 weeks measured using Diener's satisfaction with life scale in a questionnaire.
The online questionnaire will asses participants' life satisfaction using Diener's satisfaction with life scale. Changes in this measure will be examined (6 weeks to baseline) [Time Frame: Baseline to 6 weeks] Variable scale. |
Baseline - 6 weeks |