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

Not Applicable

Recruiting

• Conditions: Physical Inactivity

• Registration Number: NCT05620888
• Lead Sponsor: University of Milano Bicocca

Brief Summary

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

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).

Study Timeline

• Study Start: 2022-10-03
• Study First Submitted: 2022-10-25
• Study First Submitted QC: 2022-11-10
• Study First Posted: 2022-11-17
• Primary Completion: 2024-09-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 255

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Physical Activity	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	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.

Trial Locations

Locations (1)

University of Milano-Bicocca; 🇮🇹 Milan, MI, Italy