- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07570303
Promoting Walking Among Older Adults Through Nostalgia-Based Messages and Step-Monitoring (NOSTEP)
4-Arm Randomised Controlled Trial Testing Nostalgia-Based Messages and Step-Monitoring to Promote Walking in Older Adults Aged 65-74: A Study Protocol
Physical inactivity increases substantially after age 60 and represents a major public health challenge in older adults, as it is linked to increased risk of functional and cognitive decline and aging problems. Walking is one of the most accessible and recommended forms of moderate physical activity for this population. However, promoting sustained engagement in walking remains difficult, as traditional informational approaches often fail to activate personally meaningful motivations.
This study tests whether nostalgia-based persuasive messages can promote walking by leveraging psychologically meaningful connections with the past. Nostalgia, a predominantly positive, bittersweet emotion associated with meaningful past experience, has been shown to strengthen self-continuity, self-esteem, and psychological well-being in older adults. Building on this framework, the present trial examines whether nostalgic memories can strengthen motivation to engage in walking behavior. In addition, the study investigates whether combining nostalgia-based messaging with a self-regulation strategy (daily step monitoring) enhances intervention effectiveness. Self-monitoring is a well-established behavioral technique that supports goal pursuit by increasing awareness and feedback.
Using a randomized controlled 4-arm factorial design, the study compares the effects of nostalgia-based messages, step-monitoring, their combination, and an attention control condition on walking behavior and its psychological determinants.
A national sample of 1,000 Italian adults aged 65-74, recruited through a certified panel provider (Ipsos) and balanced for age, gender, and geographic region, will be randomly assigned to one of the four conditions. All participants will receive one message per day for 14 days via a mobile application. Participants in the self-monitoring conditions will also be asked to track and report their daily step count using a pedometer application. Behavioral, psychological, and process measures will be collected at baseline, post-intervention, and follow-up.
The study aims to provide experimental evidence on the role of nostalgia as a motivational driver of health behavior change and to clarify whether combining affective and self-regulatory strategies enhances intervention effectiveness in older adults.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Patrizia Catellani, PhD in Social Psychology
- Telefonní číslo: 393356741468
- E-mail: patrizia.catellani@unicatt.it
Studijní záloha kontaktů
- Jméno: Valentina Carfora, PhD in Social Psychology
- Telefonní číslo: 393338569908
- E-mail: valentina.carfora@unicatt.it
Studijní místa
-
-
Milan
-
Milan, Milan, Itálie, 20123
- Catholic University of the Sacred Heart (Milan)
-
Kontakt:
- Patrizia Catellani, PhD in Social Psychology
- Telefonní číslo: 393356741468
- E-mail: patrizia.catellani@unicatt.it
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Age between 65 and 74 years
- Willingness and ability to install and use the mobile applications required for study participation
- Sufficient proficiency in the Italian language to understand study materials and complete the questionnaires.
Exclusion Criteria:
- Physical disabilities or medical conditions that preclude engagement in light to moderate physical activity, specifically:
- medical advice or prescription prohibiting engagement in light to moderate physical activity, assessed via a close-ended screening question;
- positive screening on a study specific close-ended question assessing ability to perform physical activity;
- positive screening on the adapted revised Physical Activity Readiness Questionnaire (rPAR-Q), indicating that participant may be unsafe.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Faktorové přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Jiný: Control
Participants assigned to this arm will receive daily messages about the benefits of recommended daily water intake via the PsyMe app for 14 days.
|
All messages, delivered digitally via PsyMe, differ in content and do not include any walking-related prompts.
The Day 1 introductory message presents a daily water-intake goal consistent with standard recommendations and informs participants that subsequent messages describe the benefits of adequate hydration.
Participants will be encouraged to pursue the goal according to their individual capabilities.
Messages delivered from Day 2 to Day 13 provide brief information about different beneficial effects of adequate water intake and link hydration to each outcome using counterfactual formulations (e.g., "If you drink the recommended amount of water today, you may support your energy levels and help prevent lapses in concentration").
Message openings vary and include exclamatory statements, memory prompts, or rhetorical questions.
The Day 14 message concludes the intervention.
|
|
Experimentální: Nostalgia-based messages
Participants assigned to this arm will receive daily nostalgia-based walking messages via the PsyMe app for 14 days.
These messages are designed to prompt recall of positive past experiences and to encourage walking behavior.
|
All messages, delivered digitally via PsyMe, differ in content.
The Day 1 introductory message presents a daily walking goal consistent with WHO recommendations and informs participants that subsequent messages describe the benefits of walking.
Participants will be encouraged to pursue the goal according to their individual capabilities.
Messages delivered from Day 2 to Day 13 are designed to activate different positive nostalgic experiences related to walking and movement, including past memories, emotions, bodily sensations, personal values, and self-concepts.
These messages link walking behaviour to such positive experiences using counterfactual formulations (e.g., "If you walk as much as possible today, you may reconnect with sensations your body knows well.").
Message openings vary and include exclamatory statements, memory prompts, or rhetorical questions.
The Day 14 message concludes the intervention.
|
|
Aktivní komparátor: Step-monitoring
Participants assigned to this arm will receive daily reminders to monitor and record their step count through a step-tracking application via the PsyMe app for 14 days.
|
All messages, delivered digitally via PsyMe, differ in content.
The Day 1 introductory message presents a daily walking goal consistent with WHO recommendations and informs participants that subsequent messages prompt them to monitor their daily step count.
Participants will be encouraged to pursue the physical activity goal according to their individual capabilities.
Messages delivered from Day 2 to Day 13 provide reminders to monitor step counts throughout the day using the pedometer app and to record the total number of daily steps in PsyMe at the end of the day (e.g., "During the day, monitor your step count using the pedometer app.
This evening, record the total number of steps in the app.").
The Day 14 message concludes the intervention.
|
|
Experimentální: Nostalgia + Step-monitoring
Participants assigned to this arm will receive daily nostalgia-based walking messages and reminders to monitor their step count via the PsyMe app for 14 days.
|
The messages, delivered digitally via PsyMe, are constructed by combining the exact texts used in the nostalgia and step-monitoring conditions.
The Day 1 introductory message presents a daily walking goal consistent with WHO recommendations and informs participants that subsequent messages describe the benefits of walking and prompt them to monitor their daily step count.
Participants will be encouraged to pursue the physical activity goal according to their individual capabilities.
Messages delivered from Day 2 to Day 13 1) activate different positive nostalgic experiences related to walking and link walking behaviour to such positive experiences using counterfactual formulations, 2) provide reminders to track steps throughout the day using the pedometer app and record daily totals in PsyMe.
The Day 14 message concludes the intervention.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change from Baseline in Self-Reported Walking Frequency and Duration at 2-Week Post-Intervention and 4-Week Follow-up
Časové okno: Baseline and 2 weeks and 4 weeks
|
Assessed by International Physical Activity Questionnaire - Short Version (IPAQ).
|
Baseline and 2 weeks and 4 weeks
|
|
Change from Baseline in Self-Reported Walking Intensity at 2-Week Post-Intervention and 4-Week Follow-up
Časové okno: Baseline and 2 weeks and 4 weeks
|
Assessed by International Physical Activity Questionnaire - Short Version (IPAQ).
|
Baseline and 2 weeks and 4 weeks
|
|
Change from Baseline in Daily Step Count at 2-Week Post-Intervention as Measured Via Pedometer App
Časové okno: Baseline and 2 weeks
|
Baseline and 2 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change from Baseline in Self-Reported Sedentary Behaviour Duration at 2-Week Post-Intervention and 4-Week Follow-up
Časové okno: Baseline and 2 weeks and 4 weeks
|
Assessed by International Physical Activity Questionnaire - Short Version (IPAQ)
|
Baseline and 2 weeks and 4 weeks
|
|
Change from Baseline in Self-Reported Light Physical Activity Frequency and Duration at 2-Week Post-Intervention and 4-Week Follow-up
Časové okno: Baseline and 2 weeks and 4 weeks
|
Adapted from the International Physical Activity Questionnaire - Short Version (IPAQ), specifically for light physical activity.
|
Baseline and 2 weeks and 4 weeks
|
|
Change from Baseline in Self-Reported Moderate Physical Activity Frequency and Duration at 2-Week Post-Intervention and 4-Week Follow-up
Časové okno: Baseline and 2 weeks and 4 weeks
|
Assessed by International Physical Activity Questionnaire - Short Version (IPAQ).
|
Baseline and 2 weeks and 4 weeks
|
|
Change from Baseline in Self-Reported Vigorous Physical Activity Frequency and Duration at 2-Week Post-Intervention and 4-Week Follow-up
Časové okno: Baseline and 2 weeks and 4 weeks
|
Assessed by International Physical Activity Questionnaire - Short Version (IPAQ).
|
Baseline and 2 weeks and 4 weeks
|
|
Change from Baseline in Pedometer App Usage and Usage Frequency (Past Week) at 2-Week Post-Intervention and 4-Week Follow-up
Časové okno: Baseline and 2 weeks and 4 weeks
|
Measured using two study-specific items with multiple response options
|
Baseline and 2 weeks and 4 weeks
|
|
Change from Baseline in Attitude toward Walking at 2-Week Post-Intervention and 4-Week Follow-up
Časové okno: Baseline and 2 weeks and 4 weeks
|
Measured using an ad-hoc 7-point semantic differential scale assessing anticipated attitude toward walking in the next two weeks, across six bipolar adjective pairs.
Higher scores are associated with more positive attitudes toward walking.
|
Baseline and 2 weeks and 4 weeks
|
|
Change from Baseline in Intention to Walk at 2-Week Post-Intervention and 4-Week Follow-up
Časové okno: Baseline and 2 weeks and 4 weeks
|
Measured using an ad hoc 7-point Likert scale comprising 3 items and assessing intention to walk as much as possible over the next two weeks.
Responses range from 1 (completely disagree) to 7 (completely agree), with higher values indicating stronger intention to walk.
|
Baseline and 2 weeks and 4 weeks
|
|
Change from Baseline in Self-Efficacy to Walk at 2-Week Post-Intervention and 4-Week Follow-up
Časové okno: Baseline and 2 weeks and 4 weeks
|
Measured using a 12-item scale adapted from the Self-efficacy to Regulate Exercise scale (Carfora et al., 2022) to assess confidence in being able to walk as much as possible over the next two weeks under a variety of challenging circumstances.
Responses are given on a 7-point Likert scale ranging from 1 (completely disagree) to 7 (completely agree), with higher scores indicating greater self-efficacy to walk.
|
Baseline and 2 weeks and 4 weeks
|
|
Change from Baseline in Anticipated Positive Emotions Toward Walking at 2-Week Post-Intervention and 4-Week Follow-up
Časové okno: Baseline and 2 weeks and 4 weeks
|
Evaluated using an ad-hoc 6-item scale assessing anticipated positive emotions associated with walking as much as possible over the next two weeks.
Responses are given on a 7-point Likert scale ranging from 1 (completely disagree) to 7 (completely agree), with higher scores indicating stronger anticipated positive emotions toward walking.
|
Baseline and 2 weeks and 4 weeks
|
|
Change from Baseline in Anticipated Negative Emotions Toward Walking at 2-Week Post-Intervention and 4-Week Follow-up
Časové okno: Baseline and 2 weeks and 4 weeks
|
Evaluated using an ad-hoc 6-item scale assessing anticipated negative emotions associated with not walking as much as possible over the next two weeks.
Responses are given on a 7-point Likert scale ranging from 1 (completely disagree) to 7 (completely agree), with higher scores indicating stronger anticipated negative emotions toward not walking.
|
Baseline and 2 weeks and 4 weeks
|
|
Change from Baseline in Self-Reported Daily Water Intake at 2-Week Post-Intervention
Časové okno: Baseline and 2 weeks
|
Measured using an ad-hoc close-ended single-item measure assessing usual number of glasses of water consumed in an ordinary day.
|
Baseline and 2 weeks
|
|
Change from Baseline in Attitude toward Water Intake at 2-Week Post-Intervention
Časové okno: Baseline and 2 weeks
|
Measured using an ad-hoc 7-point semantic differential scale assessing anticipated attitude toward drinking at least 2 liters of water per day over the next two weeks, across six bipolar adjective pairs.
Higher scores are associated with more positive attitudes toward drinking water.
|
Baseline and 2 weeks
|
|
Change from Baseline in Intention to Drink Water at 2-Week Post-Intervention
Časové okno: Baseline and 2 weeks
|
Measured using an ad hoc 7-point Likert scale comprising 3 items and assessing intention to drink at least 2 liters of water per day over the next two weeks.
Responses range from 1 (completely disagree) to 7 (completely agree), with higher values indicating stronger intention to drink water.
|
Baseline and 2 weeks
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change from Baseline in State Nostalgia at 2-Week Post-Intervention and 4-Week Follow-up
Časové okno: Baseline and 2 weeks and 4 weeks
|
Assessed using a study-adapted 3-item scale based on Wildschut et al. (2006) to measure recent feelings of nostalgia.
The scale asks participants to indicate their agreement with statements such as "During the past week, I have felt rather nostalgic."
Responses are given on a 7-point Likert scale ranging from 1 (completely disagree) to 7 (completely agree), with higher scores indicate greater state nostalgia.
|
Baseline and 2 weeks and 4 weeks
|
|
Change from Baseline in Self-Continuity at 2-Week Post-Intervention and 4-Week Follow-up
Časové okno: Baseline and 2 weeks and 4 weeks
|
Assessed using a 4-item scale translated from the Self-Continuity Index (Sedikides et al., 2015) to measure perceived continuity and stability between past and present self.
Responses are given on a 7-point Likert scale ranging from 1 (completely disagree) to 7 (completely agree), with higher scores indicating greater self-continuity.
|
Baseline and 2 weeks and 4 weeks
|
|
Change from Baseline in Attitudes Toward Aging at 2-Week Post-Intervention
Časové okno: Baseline and 2 weeks
|
Assessed using a study-adapted 4-item scale based on the Positive View of Aging subscale of the AgeCog scale of Ongoing Development (Wurm et al., 2013) to measure positive attitudes toward aging.
Responses are given on a 7-point Likert scale ranging from 1 (completely disagree) to 7 (completely agree), with higher values reflecting more positive attitudes toward aging.
|
Baseline and 2 weeks
|
|
Change from Baseline in Psychological Well-Being at 2-Week Post-Intervention
Časové okno: Baseline and 2 weeks
|
Assessed using the Italian translation of the 5-item Short Warwick-Edinburgh Mental Well-Being Scale (Soraci et al., 2024) to measure psychological well-being over the past two weeks.
T. Responses are given on a 7-point Likert scale ranging from 1 (completely disagree) to 7 (completely agree), with higher values reflecting greater psychological well-being.
|
Baseline and 2 weeks
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Patrizia Catellani, Social Psychology, Catholic University, Italy
Publikace a užitečné odkazy
Obecné publikace
- O'Donovan G, Blazevich AJ, Boreham C, Cooper AR, Crank H, Ekelund U, Fox KR, Gately P, Giles-Corti B, Gill JM, Hamer M, McDermott I, Murphy M, Mutrie N, Reilly JJ, Saxton JM, Stamatakis E. The ABC of Physical Activity for Health: a consensus statement from the British Association of Sport and Exercise Sciences. J Sports Sci. 2010 Apr;28(6):573-91. doi: 10.1080/02640411003671212.
- Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.
- Conner M, Rhodes RE, Morris B, McEachan R, Lawton R. Changing exercise through targeting affective or cognitive attitudes. Psychol Health. 2011 Feb;26(2):133-49. doi: 10.1080/08870446.2011.531570.
- Williams DM, Evans DR. Current Emotion Research in Health Behavior Science. Emot Rev. 2014 Jul;6(3):277-287. doi: 10.1177/1754073914523052. Epub 2014 Jun 17.
- Larsen RT, Christensen J, Juhl CB, Andersen HB, Langberg H. Physical activity monitors to enhance amount of physical activity in older adults - a systematic review and meta-analysis. Eur Rev Aging Phys Act. 2019 May 4;16:7. doi: 10.1186/s11556-019-0213-6. eCollection 2019.
- Withall J, Stathi A, Davis M, Coulson J, Thompson JL, Fox KR. Objective indicators of physical activity and sedentary time and associations with subjective well-being in adults aged 70 and over. Int J Environ Res Public Health. 2014 Jan 2;11(1):643-56. doi: 10.3390/ijerph110100643.
- Williamson C, Baker G, Mutrie N, Niven A, Kelly P. Get the message? A scoping review of physical activity messaging. Int J Behav Nutr Phys Act. 2020 Apr 15;17(1):51. doi: 10.1186/s12966-020-00954-3.
- Varma VR, Dey D, Leroux A, Di J, Urbanek J, Xiao L, Zipunnikov V. Re-evaluating the effect of age on physical activity over the lifespan. Prev Med. 2017 Aug;101:102-108. doi: 10.1016/j.ypmed.2017.05.030. Epub 2017 Jun 1.
- Thogersen-Ntoumani C, Papathomas A, Foster J, Quested E, Ntoumanis N. "Shall We Dance?" Older Adults' Perspectives on the Feasibility of a Dance Intervention for Cognitive Function. J Aging Phys Act. 2018 Oct 1;26(4):553-560. doi: 10.1123/japa.2017-0203. Epub 2018 Sep 8.
- Subramaniam P, Singh DKA, Al-Shahrani HF, Hammad MA, Lim EV, Hoh XJ, Tay KW, Alavi K. Effects of combined group reminiscence and exercise therapy on psychological wellbeing and functional fitness among older adults with dementia. Sci Rep. 2025 Nov 27;15(1):42449. doi: 10.1038/s41598-025-26503-1.
- Morris JN, Hardman AE. Walking to health. Sports Med. 1997 May;23(5):306-32. doi: 10.2165/00007256-199723050-00004.
- Morris B, Lawton R, McEachan R, Hurling R, Conner M. Changing self-reported physical activity using different types of affectively and cognitively framed health messages, in a student population. Psychol Health Med. 2016;21(2):198-207. doi: 10.1080/13548506.2014.997762. Epub 2015 Jan 9.
- Hertzog C, Kramer AF, Wilson RS, Lindenberger U. Enrichment Effects on Adult Cognitive Development: Can the Functional Capacity of Older Adults Be Preserved and Enhanced? Psychol Sci Public Interest. 2008 Oct;9(1):1-65. doi: 10.1111/j.1539-6053.2009.01034.x. Epub 2008 Oct 1.
- Fleury J, Sedikides C, Wildschut T, Coon DW, Komnenich P. Feeling Safe and Nostalgia in Healthy Aging. Front Psychol. 2022 Apr 4;13:843051. doi: 10.3389/fpsyg.2022.843051. eCollection 2022.
- Catellani P, Biella M, Carfora V, Nardone A, Brischigiaro L, Manera MR, Piastra M. A theory-based and data-driven approach to promoting physical activity through message-based interventions. Front Psychol. 2023 Jul 27;14:1200304. doi: 10.3389/fpsyg.2023.1200304. eCollection 2023.
- Carfora V, Biella M, Catellani P. Affective components in promoting physical activity: A randomized controlled trial of message framing. Front Psychol. 2022 Sep 12;13:968109. doi: 10.3389/fpsyg.2022.968109. eCollection 2022.
- Carfora V, Catellani P. The Effect of Persuasive Messages in Promoting Home-Based Physical Activity During COVID-19 Pandemic. Front Psychol. 2021 Apr 1;12:644050. doi: 10.3389/fpsyg.2021.644050. eCollection 2021.
- Biondolillo MJ, Pillemer DB. Using memories to motivate future behaviour: an experimental exercise intervention. Memory. 2015;23(3):390-402. doi: 10.1080/09658211.2014.889709. Epub 2014 Feb 26.
- Biondolillo MJ, Carr KA, Wojcik K, Curry DC, Epstein LH. Effects of Episodic Memory Recall on Reinforcing Value of Physical Activity. Psychol Rep. 2025 Oct;128(5):3526-3543. doi: 10.1177/00332941231210213. Epub 2023 Oct 27.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 6069838
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Časový rámec sdílení IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Mobilní aplikace
-
Ramsay Générale de SantéClairval HospitalNáborKvalita života | Používání telefonu, mobil | Gliální jizvaFrancie