- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07581847
A Boost of Health: Effectiveness of a Personalized Communication Intervention to Increase Daily Fruit and Vegetable Intake
A Boost of Health: Effectiveness of a Personalized Communication Intervention Aimed at Increasing Daily Fruit and Vegetable Portions - A Study Within the PNRR 10 ON Foods Partnership
Studieoversikt
Status
Forhold
Detaljert beskrivelse
The present study aims to evaluate the effectiveness of a protocol designed to increase fruit and vegetable consumption, grounded in the Health Action Process Approach (HAPA).
The protocol was delivered via the MyPocketHealth app, developed by the research team, and incorporated different communication strategies. Participants were involved in setting a goal and choosing between a personalized or a standardized goal (5 daily portions), which could be reviewed at any time. Moreover, they received either interactive (HAPA-I: group 1) or non-interactive (HAPA-NI: group 2) daily notifications promoting the target behavior through HAPA constructs for 15 days, while also monitoring their daily fruit and vegetable consumption (self-monitoring). A third group engaged solely in self-monitoring without receiving any communication (no-communication group; No comm). Goal attainment was reinforced through badge awards (rewards).
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Milano
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Milan, Milano, Italia, 20126
- Adorni Roberta
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Individuals from the general population in good health
- Adequate level of education to understand study procedures and to use a smartphone
- Ownership and regular use of a smartphone
Exclusion Criteria:
- Medical conditions that contraindicate an increased consumption of fruit and vegetables
- Habitual consumption of five (or more) portions of fruit and vegetables per day at baseline
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Interactive condition (HAPA-I: group 1)
Participants received two daily notifications. Each notification included a question about a variable from the HAPA model, and participants responded on a 5-point Likert scale. Those who scored low (1-3) received a motivational message tailored to their response. In contrast, participants who scored high (4-5) received rewarding messages. These notifications gave participants feedback on their standings within the HAPA. Moreover, participants received a daily reminder to log the portions of fruit and vegetables in a dedicated self-monitoring section of the app. |
Participants received two daily notifications.
Each notification included a question about a variable from the HAPA model, and participants responded on a 5-point Likert scale.
Those who scored low (1-3) received a motivational message tailored to their response.
In contrast, participants who scored high (4-5) received rewarding messages.
These notifications gave participants feedback on their standings within the HAPA.
Participants received a daily reminder to log the portions of fruit and vegetables in a dedicated self-monitoring section of the app.
|
|
Eksperimentell: Non-interactive condition (HAPA-NI: group 2)
Participants received two daily educational notifications about HAPA variables, but they did not interact with the app. The notifications for both the HAPA-I and HAPA-NI groups were identical in structure, word count, and graphic format. The only difference was the level of content customization: it was generic for the HAPA-NI group and tailored to participants' responses for the HAPA-I group. Moreover, participants received a daily reminder to log the portions of fruit and vegetables in a dedicated self-monitoring section of the app. |
Participants received a daily reminder to log the portions of fruit and vegetables in a dedicated self-monitoring section of the app.
Participants received two daily educational notifications about HAPA variables, but they did not interact with the app.
The notifications for both the HAPA-I and HAPA-NI groups were identical in structure, word count, and graphic format.
The only difference was the level of content customization: it was generic for the HAPA-NI group and tailored to participants' responses for the HAPA-I group.
|
|
Eksperimentell: Non-communication condition (No-comm: group 3)
Participants did not receive HAPA-based notifications during the trial period.
They received a daily reminder to log the portions of fruit and vegetables in a dedicated self-monitoring section of the app.
|
Participants received a daily reminder to log the portions of fruit and vegetables in a dedicated self-monitoring section of the app.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Daily Fruit and Vegetable Intake from Baseline
Tidsramme: From Day 1 to Day 15 (end of intervention)
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Participants self-monitored daily fruit and vegetable intake throughout the study period.
Each evening, participants received a reminder and recorded the number of fruit and vegetable portions consumed that day via a dedicated app interface.
At the end of the 15-day intervention, the mean daily intake was calculated for each participant.
This value was then compared with baseline intake (assessed prior to the start of the intervention) to evaluate whether a statistically significant increase in daily fruit and vegetable consumption was observed.
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From Day 1 to Day 15 (end of intervention)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Perceived Well-Being (WHO-5 Index)
Tidsramme: Baseline and Day 15 (end of intervention)
|
Perceived well-being is assessed using the WHO-5 Well-Being Index, a validated self-report questionnaire that measures subjective psychological well-being.
The WHO-5 consists of five items rated on a 6-point Likert scale, with higher scores indicating greater well-being.
Scores are collected at baseline and at the end of the 15-day intervention.
The outcome is defined as the change in WHO-5 score from baseline to post-intervention.
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Baseline and Day 15 (end of intervention)
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Marco D'Addario, PhD, University of Milano Bicocca
- Hovedetterforsker: Maria Elide Vanutelli, PhD, University of Milano Bicocca
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Fjeldsoe B, Neuhaus M, Winkler E, Eakin E. Systematic review of maintenance of behavior change following physical activity and dietary interventions. Health Psychol. 2011 Jan;30(1):99-109. doi: 10.1037/a0021974.
- Aune D, Giovannucci E, Boffetta P, Fadnes LT, Keum N, Norat T, Greenwood DC, Riboli E, Vatten LJ, Tonstad S. Fruit and vegetable intake and the risk of cardiovascular disease, total cancer and all-cause mortality-a systematic review and dose-response meta-analysis of prospective studies. Int J Epidemiol. 2017 Jun 1;46(3):1029-1056. doi: 10.1093/ije/dyw319.
- Schwarzer, R. (2008). Modeling health behavior change: How to predict and modify the adoption and maintenance of health behaviors. Applied Psychology: An International Review, 57(1), 1-29. https://doi.org/10.1111/j.1464-0597.2007.00325.x
- Mujcic R, J Oswald A. Evolution of Well-Being and Happiness After Increases in Consumption of Fruit and Vegetables. Am J Public Health. 2016 Aug;106(8):1504-10. doi: 10.2105/AJPH.2016.303260.
- Kamphuis CB, van Lenthe FJ, Giskes K, Brug J, Mackenbach JP. Perceived environmental determinants of physical activity and fruit and vegetable consumption among high and low socioeconomic groups in the Netherlands. Health Place. 2007 Jun;13(2):493-503. doi: 10.1016/j.healthplace.2006.05.008. Epub 2006 Jul 11.
- D'Addario M, Cappelletti ER, Sarini M, Greco A, Steca P. The TTCYB Study Protocol: A Tailored Print Message Intervention to Improve Cardiovascular Patients' Lifestyles. Int J Environ Res Public Health. 2020 Apr 23;17(8):2919. doi: 10.3390/ijerph17082919.
- Blanchflower, D. G., Oswald, A. J., & Stewart-Brown, S. (2013). Is psychological well-being linked to the consumption of fruit and vegetables? Social Indicators Research, 114(3), 785-801. https://doi.org/10.1007/s11205-012-0173-y
- Adorni R, Zanatta F, Cappelletti ER, Greco A, Steca P, D'Addario M. Effectiveness of a tailored communication intervention to improve physical activity in hypertensive patients: a twelve-month randomized controlled trial. BMC Cardiovasc Disord. 2024 Mar 5;24(1):143. doi: 10.1186/s12872-024-03786-2.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RM-2024-882
- PE00000003;CUP D93C22000890001 (Annet stipend/finansieringsnummer: Italian Ministry of University and Research funded by the European Union - NextGenerationEU)
Plan for individuelle deltakerdata (IPD)
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