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Eine Studie entspricht den Filterkriterien
Kartenansicht
Efficacy of a Tailored Communication Intervention Aimed At Increasing the Number of Daily Steps
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Die klinische Studie NCT05620888 ist eine interventionsstudie zur Untersuchung von Körperliche Inaktivität und hat den Status offene rekrutierung. Die Studie startete am 3. Oktober 2022 und soll 255 Teilnehmer aufnehmen. Durchgeführt von University of Milano Bicocca ist der Abschluss für 1. Juni 2025 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 9. Dezember 2024 aktualisiert.
Kurzbeschreibung
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.
Ausführliche Beschreibung
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).
Offizieller Titel
Efficacy of a Tailored Communication Intervention Aimed At Increasing the Number of Daily Steps
Erkrankungen
Körperliche InaktivitätPublikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Weitere Studien-IDs
- RM-2021-482
NCT-Nummer
Studienbeginn (tatsächlich)
2022-10-03
Zuletzt aktualisiert
2024-12-09
Studienende (vorauss.)
2025-06
Geplante Rekrutierung
255
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
Physical Activity
Tailored communication
Behavior Change
Self Efficacy
Health Action Process Approach
Persuasive Communication
Walking
Tailored communication
Behavior Change
Self Efficacy
Health Action Process Approach
Persuasive Communication
Walking
Primäres Ziel
Prävention
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Einfach verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellTailored messages (TM) 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. | Walk Behavior Change: Tailored Messages (TM) 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. |
ExperimentellNon tailored messages (NTM) 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. | Walk Behavior Change: Non Tailored Messages (NTM) 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. |
Keine InterventionNo messages (NM) 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. | Nicht zutreffend |
Hauptergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
Akzeptiert gesunde Freiwillige
Ja
- 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
- 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
University of Milano Bicocca- Universität Neapel Federico II93 aktive klinische Studien zum Erkunden
- University of Bergamo
Verantwortliche Partei
Marco D'Addario, Hauptprüfer, Associate Professor, University of Milano Bicocca
Zentrale Studienkontakte
Kontakt: Marco D'Addario, PhD, 0039 02 6448 3824, [email protected]
Kontakt: Roberta Adorni, PhD, [email protected]
1 Studienstandorte in 1 Ländern
MI
University of Milano-Bicocca, Milan, MI, 20126, Italy
Marco D'Addario, PhD, Kontakt, 0039 02 6448 3824, [email protected]
Roberta Adorni, PhD, Kontakt, [email protected]
Offene Rekrutierung