- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Milano
-
Milan, Milano, Italy, 20126
- Adorni Roberta
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Daily Fruit and Vegetable Intake from Baseline
Time Frame: From Day 1 to Day 15 (end of intervention)
|
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.
|
From Day 1 to Day 15 (end of intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Perceived Well-Being (WHO-5 Index)
Time Frame: 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.
|
Baseline and Day 15 (end of intervention)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marco D'Addario, PhD, University of Milano Bicocca
- Principal Investigator: Maria Elide Vanutelli, PhD, University of Milano Bicocca
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RM-2024-882
- PE00000003;CUP D93C22000890001 (Other Grant/Funding Number: Italian Ministry of University and Research funded by the European Union - NextGenerationEU)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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