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Physical InactivityNCT05620888

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

A study testing Walk behavior change: Tailored messages (TM) and Walk behavior change: Non tailored messages (NTM) in people with Physical Inactivity, run by University of Milano Bicocca at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Physical Inactivity
What is being tested?
Walk behavior change: Tailored messages (TM) and Walk behavior change: Non tailored messages (NTM)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
255 participants
Where
1 siteItaly
Study dates
3 Oct 2022to Jun 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marco D'Addario, PhD contact

0039 02 6448 3824

marco.daddario@unimib.it

Roberta Adorni, PhD contact

roberta.adorni1@unimib.it

Italy1 site, 1 recruiting
  • University of Milano-Bicocca

    Milan, MI, 20126

    Marco D'Addario, PhD, 0039 02 6448 3824, marco.daddario@unimib.it

    Roberta Adorni, PhD, roberta.adorni1@unimib.it

    Recruiting

Other trials in Italy

About this study

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.

Read the 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).

Being tested
Walk behavior change: Tailored messages (TM), Walk behavior change: Non tailored messages (NTM)
Keywords
Physical Activity, Tailored communication, Behavior Change, Self Efficacy, Health Action Process Approach, Persuasive Communication, Walking
Medical subject headings
Sedentary Behavior, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Walk behavior change: Tailored messages (TM)Behavioural

    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)Behavioural

    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.

Study groups in NCT05620888
Study groupRoleWhat they receive
Tailored messages (TM)ExperimentalParticipants 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.
Receives: Behavioral: Walk behavior change: Tailored messages (TM)
Non tailored messages (NTM)ExperimentalParticipants 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.
Receives: Behavioral: Walk behavior change: Non tailored messages (NTM)
No messages (NM)No interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: Baseline and 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2022
  2. Study start3 Oct 2022
  3. Primary completion30 Sep 2024
  4. Study completionJun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
255 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05620888
Sponsor's protocol ID
RM-2021-482
Status last verified
Dec 2024
First submitted
25 Oct 2022
Last updated
9 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Davis A, Sweigart R, Ellis R. A systematic review of tailored mHealth interventions for physical activity promotion among adults. Transl Behav Med. 2020 Oct 12;10(5):1221-1232. doi: 10.1093/tbm/ibz190.

    PubMed 33044542
  • Martin-Martin J, Roldan-Jimenez C, De-Torres I, Muro-Culebras A, Escriche-Escuder A, Gonzalez-Sanchez M, Ruiz-Munoz M, Mayoral-Cleries F, Biro A, Tang W, Nikolova B, Salvatore A, Cuesta-Vargas AI. Behavior Change Techniques and the Effects Associated With Digital Behavior Change Interventions in Sedentary Behavior in the Clinical Population: A Systematic Review. Front Digit Health. 2021 Jul 8;3:620383. doi: 10.3389/fdgth.2021.620383. eCollection 2021.

    PubMed 34713097
  • Newsome A, Gilliard T, Phillips A, Dedrick R. Understanding the perceptions of sedentary college students' engagement in physical activity: application of the theory of planned behavior. J Am Coll Health. 2023 Dec;71(9):2813-2822. doi: 10.1080/07448481.2021.1998069. Epub 2021 Nov 17.

    PubMed 34788584
  • Romeo A, Edney S, Plotnikoff R, Curtis R, Ryan J, Sanders I, Crozier A, Maher C. Can Smartphone Apps Increase Physical Activity? Systematic Review and Meta-Analysis. J Med Internet Res. 2019 Mar 19;21(3):e12053. doi: 10.2196/12053.

    PubMed 30888321
  • Rowley TW, Lenz EK, Swartz AM, Miller NE, Maeda H, Strath SJ. Efficacy of an Individually Tailored, Internet-Mediated Physical Activity Intervention in Older Adults: A Randomized Controlled Trial. J Appl Gerontol. 2019 Jul;38(7):1011-1022. doi: 10.1177/0733464817735396. Epub 2017 Oct 25.

    PubMed 29165018
  • Steca P, Pancani L, Cesana F, Fattirolli F, Giannattasio C, Greco A, D'Addario M, Monzani D, Cappelletti ER, Magrin ME, Miglioretti M, Sarini M, Scrignaro M, Vecchio L, Franzelli C. Changes in physical activity among coronary and hypertensive patients: A longitudinal study using the Health Action Process Approach. Psychol Health. 2017 Mar;32(3):361-380. doi: 10.1080/08870446.2016.1273353. Epub 2017 Jan 4.

    PubMed 28049344
  • Tudor-Locke C, Bassett DR Jr. How many steps/day are enough? Preliminary pedometer indices for public health. Sports Med. 2004;34(1):1-8. doi: 10.2165/00007256-200434010-00001.

    PubMed 14715035
  • Zhang CQ, Zhang R, Schwarzer R, Hagger MS. A meta-analysis of the health action process approach. Health Psychol. 2019 Jul;38(7):623-637. doi: 10.1037/hea0000728. Epub 2019 Apr 11.

    PubMed 30973747
  • Carfora V, Caso D, Palumbo F, Conner M. Promoting water intake. The persuasiveness of a messaging intervention based on anticipated negative affective reactions and self-monitoring. Appetite. 2018 Nov 1;130:236-246. doi: 10.1016/j.appet.2018.08.017. Epub 2018 Aug 16.

    PubMed 30121311
  • Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. doi: 10.1097/00005650-198601000-00007.

    PubMed 3945130
  • Ajzen I. The theory of planned behavior. Organizational Behavior and Human Decision Processes. 1991; 50(2): 179-211.

  • Mannocci A, Di Thiene D, Del Cimmuto A, Masala D, Boccia A, De Vito E, La Torre G. International Physical Activity Questionnaire: validation and assessment in an Italian sample. Italian Journal of Public Health. 2012; 7(4)

  • Schwarzer R. Modeling health behavior change: How to predict and modify the adoption and maintenance of health behaviors. Applied Psychology. 2008; 57(1): 1-29

  • Adorni R, Zanatta F, Serino S, Vanutelli ME, Caso D, D'Addario M, Steca P. Efficacy of a theory-based and tailored mHealth intervention promoting walking behavior: a preliminary randomized controlled trial. Sci Rep. 2025 Jul 18;15(1):26033. doi: 10.1038/s41598-025-09634-3.

    PubMed 40676042

Questions about this trial

What is this clinical trial studying?

A study testing Walk behavior change: Tailored messages (TM) and Walk behavior change: Non tailored messages (NTM) in people with Physical Inactivity, run by University of Milano Bicocca at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marco D'Addario, PhD (0039 02 6448 3824, marco.daddario@unimib.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Physical Activity (time frame: Baseline and 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05620888, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.

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