"Increasing Physical Activity in Canadian Adults Who Have Been Affected by COVID-19 Social Distancing Restrictions: A Feasibility Trial of an Online Intervention"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 4
- 主要终点
- Participant retention
研究概览
简要总结
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.
详细描述
Background: Physical activity is associated with management and/or prevention of over 25 chronic health conditions; however the majority of adults in North America are not active enough to experience these benefits. Behavioral strategies have been shown to be effective for increasing physical activity, and our online platform includes components of several behavioral strategies including goal setting and feedback.
Target Population: Participants will be Canadian adults over 18 who have
- recently started practising social distancing due to our current COVID-19 situation
- currently are participating in physical activity below Canadian recommended guidelines (150 minutes of moderate to vigorous activity per week).
- Participants must have access to the Internet. Sample Size: 40 participants, 20 participants per group - (Control) 20 participants (intervention) Participants will be excluded from the project if they do not have access to the Internet, are unable to speak/read English, are not 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 (assessed using the GAQ. Screening will be completed formally over the phone, and participants will give their consent online.
Condition one: Waitlist control group: One group (evenly representing Adults practising social distancing) will complete the 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. Access to the online platform is for study participant use and benefit only and no participant data/website analytics will be collected at this point in the study.
Condition two: One group (evenly representing Adults practising social distancing) will complete the online baseline questionnaire, and receive access to the online platform. Briefly, the participants will be shown (via skype, Face time, Zoom or other alternate online technology) how to use it .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
Participant retention
时间窗: 6 weeks
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).
Participant intervention satisfaction/evaluation
时间窗: 6 Weeks
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.
Recruitment rate (monthly)
时间窗: 4 months
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.
次要结局
- Change in self-reported physical activity from baseline to 6 weeks(6 Weeks)
- Change in physical activity identity 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 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 life satisfaction measured using the Short Form 12 questionnaire from baseline to 6 weeks(Baseline - 6 weeks)
研究者
Ryan Rhodes
Professor Ryan Rhodes
University of Victoria