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临床试验/NCT04116372
NCT04116372已完成不适用

Increasing Physical Activity in Empty Nest and Retirement Populations: A Feasibility Trial of an Online Intervention

University of Victoria1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2019年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
1
主要终点
Recruitment rate (monthly)

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 and acceptability of a web-based physical activity behavior change program on recently retired and/or empty nest populations. The primary research question is: Is it worthwhile to conduct a larger scale eHealth study targeting empty nest and/or retired populations based on preliminary results and feedback from this pilot study. We will also be examining changes other behavioral indicators related to physical activity 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: Sedentary adults who have recently (within 6 months of enrollment) retired, or had their last child leave the family home, living in Victoria, British-Columbia, Canada.

Sample Size: 80 participants, 20 participants per group - Empty Nest (Control) Empty Nest (intervention), Retired (Control), Retired (Intervention).

Intervention: Participants in each Empty Nest and Retirement participant pool will be randomized to two groups: 1 - Waitlist control group, 2 - Access to Online Platform. Half of the empty nest participant group and half of the retired participant group will receive an intervention, with the other half representing the control comparison group. Participants from both groups will complete an online questionnaires at baseline and 10 weeks. The intervention group will also be asked for an in-person exit interview.

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
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Potential participants will be included if they have either a) recently (within 6 months) retired, or b) experienced children moving out of the familial home. In addition, potential 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. Potential participants must currently be not meeting the physical activity (PA) guidelines (less than 150 minutes of moderate to vigorous aerobic activity). There will be no delimitations to the sample based on socio-economic or ethnic variables.

排除标准

  • Participants will be excluded from the project if they 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 (assessed using the GAQ)

结局指标

主要结局

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. If we decide on a three armed trial, we will need to recruit at least 8 per month.

Participant retention

时间窗: 10 weeks

Number of participants who complete both baseline and end of study (10 week) measures. A 80-100% retention rate is indicative of a strong trial (Jackson \& Waters, 2005).

Participant intervention satisfaction/evaluation

时间窗: 10 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.

次要结局

  • Change in physical activity beliefs, attitudes, barriers, and motivation from baseline to 10 weeks.(Baseline - 10 weeks)
  • Change in physical activity habits from baseline to 10 weeks.(Baseline - 10 weeks)
  • Change in quality of life measured using the Short Form 12 questionnaire.(Baseline - 10 weeks)
  • Change in self-reported physical activity from baseline to 10 weeks(Baseline - 10 weeks)
  • Change in physical activity behaviour regulation from baseline to 10 weeks.(Baseline - 10 weeks)
  • Change in physical activity identity from baseline to 10 weeks.(Baseline - 10 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ryan Rhodes

Professor Ryan Rhodes

University of Victoria

研究点 (1)

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