Efficacy of a Tailored Communication Intervention Aimed at Increasing the Number of Daily Steps

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Efficacy of a Tailored Communication Intervention Aimed at Increasing the Number of Daily Steps

Conditions
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Physical Inactivity

Intervention / Treatment
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* Behavioral: Walk behavior change: Tailored messages (TM)
* Behavioral: Walk behavior change: Non tailored messages (NTM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tailored messages (TM)<br>Participants assigned to this arm receive a daily tailored message on the benefits of taking at least 7000 steps daily. Tailoring concerns change-related expectations, risk perception, planning, retention capacity, resilience, and coping skills and is based on the responses provided by participants at baseline evaluation. In addition, they receive a daily request to declare the number of steps taken (walking self-monitoring).In particular, every evening, the mobile application sends a message to the participants requesting to enter the number of steps taken during the day in a dedicated app section. | Behavioral: Walk behavior change: Tailored messages (TM)<br>* Every afternoon at the same time, the mobile application sends a message to the participants of the TM arm. The message is tailored based on the answers provided to the pre-intervention questionnaire. An example message is: you think you are not able to walk regularly when your morale is low: do not give up because physical activity is also good for the mood! The intervention is provided for 30 days.<br>|
| Experimental: Non tailored messages (NTM)<br>Participants assigned to this arm receive a daily non-tailored message on the emotional benefits of taking at least 7000 steps daily. In addition, they receive a daily request to declare the number of steps taken (walking self-monitoring). In particular, every evening, the mobile application sends a message to the participants requesting to enter the number of steps taken during the day in a dedicated app section. | Behavioral: Walk behavior change: Non tailored messages (NTM)<br>* Every afternoon at the same time, the mobile application sends a message to the participants of the NTM arm. The message concerns the emotional well-being resulting from the performance of the physical activity and is not tailored. An example message is: walking regularly in the fresh air improves your mood. The intervention is provided for 30 days.<br>|
| No Intervention: No messages (NM)<br>Participants assigned to this arm receive a daily request to declare the number of steps taken (walking self-monitoring). In particular, every evening, the mobile application sends a message to the participants requesting to enter the number of steps taken during the day in a dedicated app section. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Physical Activity | 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. | Baseline and 30 days | 
| Change from Baseline in Walk behavior | 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. | Baseline and 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Activity, Tailored communication, Behavior Change, Self Efficacy, Health Action Process Approach, Persuasive Communication, Walking