Efficacy of a Tailored Communication Intervention Aimed At Increasing the Number of Daily Steps
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 255
- 试验地点
- 2
- 主要终点
- Change from Baseline in Physical Activity
研究概览
简要总结
This study aims to evaluate the efficacy of a physical activity promotion intervention focused on walking behavior. The intervention is delivered via mobile application in a sample drawn from the healthy adult population.
详细描述
A sample of sedentary adults will be invited to participate in a 30 days intervention delivered via a mobile app to achieve the goal of 7,000 daily steps.
Before and after the intervention, some crucial variables will be evaluated for the formation of the intention to change behavior and for the transition from intention to action (attitudes, subjective norms, self-efficacy, expectations related to change, risk perception, social support, planning) to compare two models of behavioral change.
During the intervention, messages will be sent daily, and the number of steps taken daily will be monitored. The aim is to compare the effectiveness of two types of communication in promoting a positive behavioral change: non-personalized communication centered on well-being (non-tailored communication) vs. personalized communication based on the psychological characteristics evaluated before the intervention (tailored communication). The physical activity carried out over 30 days by the participants who will receive the messages (tailored and non-tailored) will be compared with the physical activity carried out by participants who will not receive any messages (control group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
The baseline assessment, the intervention, and the post-intervention assessment are provided automatically via the mobile app. In addition, participants are randomly assigned to a specific experimental group before starting the study and do not know which experimental group they are assigned. These features of the study minimize observer bias.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants from the general population, in good health and sedentary
- •A level of education sufficient to understand the procedures of the study and to use a smartphone
- •Having a smartphone
排除标准
- •The participant always (or almost always) takes at least 7,000 steps a day
- •The participant achieves an IPAQ score equal to or greater than 3000 MET-min / week
- •The participant has symptoms or pathologies that could represent a contraindication to the physical activity proposed by the study. In particular
- •Cardiovascular diseases for which physical activity is allowed only under medical supervision
- •Chest pain during daily activities
- •Drug treatment for cardiovascular diseases
- •Severe arterial hypertension not pharmacologically controlled
- •Episodes of loss of consciousness within the past 12 months
- •Osteoarticular disorders that could be aggravated by a change in the level of physical activity
- •Fractures of the lower limbs, vertebrae, or pelvis in the past six months
- •Walking difficulty
- •Respiratory insufficiency
结局指标
主要结局
Change from Baseline in Physical Activity
时间窗: Baseline and 30 days
Physical activity is assessed with the International Physical Activity Questionnaire (IPAQ; Mannocci et al., 2010). The scale comprises seven items on Physical Activity providing information about time spent walking, moderate and vigorous intensity, and sedentary activity. The elements are structured to provide separate scores for walking, moderate and vigorous intensity activity, and a combined total score to describe the overall activity level. Data collected with IPAQ are reported as a continuous measure and reported as MET-median minutes.
Change from Baseline in Walk behavior
时间窗: Baseline and 30 days
Walk behavior is self-monitored daily. Each evening, participants receive a message and enter the number of steps taken in a specific app section based on the data reported on the smartwatch or the smartphone's native app. The mean number of steps at the intervention's beginning and the end is then calculated. These two measures are compared to verify whether a statistically significant increase in daily steps is observed over time.
次要结局
未报告次要终点
研究者
Marco D'Addario
Associate Professor
University of Milano Bicocca