Interactive Condition (HAPA-I: Group 1)NCT07581847
A Boost of Health: Effectiveness of a Personalized Communication Intervention to Increase Daily Fruit and Vegetable Intake
A study testing Interactive communication, Non-interactive Communication and Self-monitoring in people with Interactive Condition (HAPA-I: Group 1) and Non-interactive Condition (HAPA-NI: Group 2), run by Marco D'Addario at 1 site in Italy.
Trial summary
This study aims to evaluate the efficacy of a healthy diet promotion intervention focused on increasing fruit and vegetable consumption. The intervention is delivered via mobile application in a sample drawn from the healthy adult population. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Interactive Condition (HAPA-I: Group 1), Non-interactive Condition (HAPA-NI: Group 2), Non-communication Condition (No Comm: Group 3)
- What is being tested?
- Interactive communication, Non-interactive Communication and Self-monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 403 participants
- Where
- 1 siteItaly
- Study dates
- 3 Dec 2024to 16 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
This study aims to evaluate the efficacy of a healthy diet promotion intervention focused on increasing fruit and vegetable consumption. The intervention is delivered via mobile application in a sample drawn from the healthy adult population.
Read the 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).
- Conditions
- Interactive Condition (HAPA-I: Group 1), Non-interactive Condition (HAPA-NI: Group 2), Non-communication Condition (No Comm: Group 3)
- Being tested
- Interactive communication, Non-interactive Communication, Self-monitoring
- Keywords
- mHealth, Health Action Process Approach, Healthy Diet, Behavioral Change techniques, Behavioral Goal Setting, Self-monitoring, Rewards
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive communicationBehavioural
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.
Non-interactive CommunicationBehavioural
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.
Self-monitoringBehavioural
Participants received a daily reminder to log the portions of fruit and vegetables in a dedicated self-monitoring section of the app.
| Study group | Role | What they receive |
|---|---|---|
| Interactive condition (HAPA-I: group 1) | Experimental | 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. Receives: Behavioral: Interactive communication; Behavioral: Self-monitoring |
| Non-interactive condition (HAPA-NI: group 2) | Experimental | 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. Receives: Behavioral: Non-interactive Communication; Behavioral: Self-monitoring |
| Non-communication condition (No-comm: group 3) | Experimental | 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. Receives: Behavioral: Self-monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Daily Fruit and Vegetable Intake from Baseline
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.
Measured: From Day 1 to Day 15 (end of intervention)
Secondary outcomes (1)
Change in Perceived Well-Being (WHO-5 Index)
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.
Measured: Baseline and Day 15 (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start3 Dec 2024
- Primary completion16 Jan 2026
- Study completion16 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Interactive Condition (HAPA-I: Group 1)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marco D'Addario
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marco D'Addario, University of Milano Bicocca
- Investigators
- Marco D'Addario, PhD, Principal investigator, University of Milano BicoccaMaria Elide Vanutelli, PhD, Principal investigator, University of Milano Bicocca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581847
- Sponsor's protocol ID
- RM-2024-882
- Other IDs
- PE00000003;CUP D93C22000890001
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27400354Kamphuis 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.
PubMed 16815073Fjeldsoe 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.
PubMed 21299298D'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.
PubMed 32340219Blanchflower, 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
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.
PubMed 28338764Adorni 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.
PubMed 38443805
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07581847
- Acronym / sponsor ID
- RM-2024-882
- Conditions
- Interactive Condition (HAPA-I: Group 1), Non-interactive Condition (HAPA-NI: Group 2), Non-communication Condition (No Comm: Group 3)
- Keywords
- mHealth, Health Action Process Approach, Healthy Diet, Behavioral Change techniques, Behavioral Goal Setting, Self-monitoring, Rewards
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Marco D'AddarioUniversity, hospital or other
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 16 Jan 2026 (actual)
- Study completion
- 16 Jan 2026 (actual)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the efficacy of a healthy diet promotion intervention focused on increasing fruit and vegetable consumption. The intervention is delivered via mobile application in a sample drawn from the healthy adult population.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interactive condition (HAPA-I: group 1) | Experimental | Behavioral: Interactive communication, Behavioral: Self-monitoringParticipants 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. |
| Non-interactive condition (HAPA-NI: group 2) | Experimental | Behavioral: Non-interactive Communication, Behavioral: Self-monitoringParticipants 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. |
| Non-communication condition (No-comm: group 3) | Experimental | Behavioral: Self-monitoringParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive communicationParticipants 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. | Behavioural | Interactive condition (HAPA-I: group 1) |
| Non-interactive CommunicationParticipants 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. | Behavioural | Non-interactive condition (HAPA-NI: group 2) |
| Self-monitoringParticipants received a daily reminder to log the portions of fruit and vegetables in a dedicated self-monitoring section of the app. | Behavioural | Interactive condition (HAPA-I: group 1), Non-communication condition (No-comm: group 3), Non-interactive condition (HAPA-NI: group 2) |
Primary outcome
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.
1 secondary outcome
Change in Perceived Well-Being (WHO-5 Index)
Time frame: Baseline and Day 15 (end of intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- BackgroundSchwarzer, 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
- Background: PubMed 27400354Mujcic 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.
- Background: PubMed 16815073Kamphuis 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.
- Background: PubMed 21299298Fjeldsoe 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.
- Background: PubMed 32340219D'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.
- BackgroundBlanchflower, 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
- Background: PubMed 28338764Aune 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.
- Background: PubMed 38443805Adorni 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco D'Addario, PhD principal investigator
University of Milano Bicocca
Maria Elide Vanutelli, PhD principal investigator
University of Milano Bicocca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive communication, Non-interactive Communication and Self-monitoring in people with Interactive Condition (HAPA-I: Group 1) and Non-interactive Condition (HAPA-NI: Group 2), run by Marco D'Addario at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Daily Fruit and Vegetable Intake from Baseline (time frame: From Day 1 to Day 15 (end of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07581847, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.