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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Milano Bicocca

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Walk behavior change: Tailored messages (TM)

    Behavioral

    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.

  • Walk behavior change: Non tailored messages (NTM)

    Behavioral

    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.

Treatment groups

255 Participants
are divided into 3 treatment groups
Group A: Tailored messages (TM)Experimental treatment 1 intervention
Group B: Non tailored messages (NTM)Experimental treatment 1 intervention
Group C: No messages (NM)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and 30 days
2

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.

Time frame
Baseline and 30 days

Secondary outcomes

Other outcomes

1

Adherence to a healthy lifestyle: diet

Regarding adherence to a healthy lifestyle, participants report the frequency of consumption of 17 different food types through a 7-point Likert scale. The items were taken from a survey of the National Institute of Statistics (https://www.istat.it/it/archivio/91926). We will classify each behavior as adequate (score = 1) or inadequate (score = 0), following international and national guidelines. We will add up the scores obtained for specific foods similar to the MedDietScore scale (Trichopoulou et al., 2003), in order to build a diet adequacy index for use in subsequent analyses. The higher the score, the higher the adherence to guidelines.

Time frame
Baseline
2

Adherence to a healthy lifestyle: alcohol consumption

Participants report the frequency of consumption of alcoholic beverages during the last month through a 6-point Likert scale (1 = almost every day; 6 = never). The higher the score, the higher the adherence to guidelines.

Time frame
Baseline
3

Adherence to a healthy lifestyle: smoking

Participants report if they smoke, and the frequency of smoking through a 6-point Likert scale (1 = every day; 6 = never). The higher the score, the higher the adherence to guidelines.

Time frame
Baseline
4

Adherence to a healthy lifestyle: medication

Medication adherence is evaluated using the brief Italian version of the Morisky Green Levine Scale (MGLS), a questionnaire consisting of 4 questions with dichotomous answers (yes or no). Each behavior is classified as adequate (score = 1) or inadequate (score = 0). The item responses are added up. The higher the score, the higher the medication adherence. A total score of \<2 is indicative of poor adherence.

Time frame
Baseline

Sponsors and contacts

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University of Milano Bicocca

Lead sponsor

Federico II University

Collaborator

University of Bergamo

Collaborator