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

Overview

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).

Interventions

• Behavioral 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.
• Behavioral 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.

Primary outcome measures

• Change from Baseline in Physical Activity [Time frame: Baseline and 30 days]
• Change from Baseline in Walk behavior [Time frame: Baseline and 30 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Italy · 1 center

• University of Milano-Bicocca — Milan

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. PMID 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;3:62 PMID 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. PMID 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. PMID 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. PMID 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 201 PMID 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. PMID 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. PMID 30973747

Identifiers

NCT: NCT05620888 · RM-2021-482

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗