Health BehaviorNCT05785260
Promoting Mental and Physical Well-being Through Smart Health
An observational study of Health Behavior and Healthy Lifestyle, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial summary
The objective of the study is to develop a smartphone application dedicated to health prevention in terms of monitoring physical activity and healthy eating, mediated by the use of Mindfulness-ACT exercises to reduce unhealthy lifestyles and monitoring through the use of engineered wearable bands. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Healthy Lifestyle
- What is being tested?
- ACT MINDFULNESS
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 27 Jul 2022to 31 Dec 2022
- How long will I take part?
- 10 Days
- Phase
- Observational
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Forty subjects (20 adult subjects for the experimental group and 20 adult subjects for the control group) were recruited from the Bonino-Pulejo Neurolesi Center in Messina, Italy.
Who may be able to join
- Age of subjects: 50-85 years
- Subjects with global cognitive functioning at normal limits (mmse ≥ 20)
- Subjects with diagnosed mild and/or absent depression;
Who cannot join
- Diagnosis of dementia
- Diagnosis of moderate/severe depression
- Language disorders
- Psychiatric disorders
- Praxic deficits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Promoting and Supporting Mental and Physical Well-being: the Role of Smart Health in the Prevention of Cerebrocardiovascular Disease
The objective of the study is to develop a smartphone application dedicated to health prevention in terms of monitoring physical activity and healthy eating, mediated by the use of Mindfulness-ACT exercises to reduce unhealthy lifestyles and monitoring through the use of engineered wearable bands.
This is a nonpharmacological prospective observational study. The procedure includes consecutive enrollment in the study of 40 subjects who meet all inclusion criteria. Patients will undergo comprehensive cognitive assessment with collection of all medical history data and information on current clinical condition, including dietary lifestyle. After that they will be invited to register on Brainhearth platform, and then via the app monitoring of physical activity and nutrition, mediated by the use of Mindfulness-ACT exercises, will take place.
Read the detailed description
The Brainheart study aims to develop a smartphone application connected to a smartwatch dedicated to the prevention of cardiovascular disease among the elderly in their activities of daily living. In addition, to promote health by monitoring physical activity through special engineered bands and healthy eating, mediated by the use of Mindfulness-ACT exercises and appropriate dietary regimen, according to the attached scheme (Appendix A);to acquire physiological and behavioral correlates through the BRAINHEART platform;to develop physical activity, nutrition and interactive exercise programs based on MCBT and ACT; administering contextualized MCBT and ACT cognitive behavioral exercises to promote program adherence;enhancing meta-cognitive skills through a better understanding of the individual with respect to his or her own cognitive processes and their functioning;improving quality of life and one's mental and physical well-being;increasing scientific and clinical knowledge for mental and physical well-being and strategies to promote it;increasing sense of self-efficacy and self-esteem. To achieve these goals, the application developed on a mobile platform, will be designed by integrating:
- a multi-sensory wearable device capable of acquiring and processing physiological and behavioral data to monitor physical and mental health status
- advanced artificial intelligence-based decision support models that can recognize physical and mental health status and provide personalized physical activity and nutrition programs
- exercises and interactive games based on the cognitive behavioral technique Mindfulness and ACT, contextualized and customized in order to increase awareness of health status and motivate the elderly to pursue a healthy lifestyle and best follow the cerebrocardiovascular disease prevention program
STUDY DESIGN.
This is a nonpharmacological prospective observational study.
DURATION OF THE STUDY
Overall, the study will have a duration of 12 months.
STUDY POPULATION
A total of 40 subjects will be consecutively enrolled in the study who are afferent to the facility's outpatient clinics and meet all inclusion criteria, and who will be evaluated at the time of recruitment (T0), and at 6 (T1) and 12 months (T2) intervals. All patients will be assessed by the (a) MMSE, (b) batteries provided within the Brief Neuropsychological Examination, (c) quality of life assessment questionnaires, and (d) Mini Nutritional Assessment (see Annex A to this protocol).
Inclusion criteria
- Age of subjects: 50-85 years.
- Subjects with global cognitive functioning at normal limits (MMSE ≥ 20)
- Subjects with a diagnosis of mild and/or absent depression
Exclusion criteria.
- Diagnosis of dementia
- Diagnosis of moderate/severe depression
- Speech disorders;
- Psychiatric disorders;
- Praxic deficits.
Materials
The project involves the use of:
- portable devices with adequate computational and memory capabilities;
- wireless wearable sensors capable of simultaneously measuring heart rate (HR), and physical activity using triaxial accelerometer;
- mobile processing units for extraction of biosignal features and automatic classification of stress levels.
- Conditions
- Health Behavior, Healthy Lifestyle
- Being tested
- ACT MINDFULNESS
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT MINDFULNESSBehavioural
Mindfulness (MCBT) practices were offered to patients with the aim of fostering the elderly's pro-active role in health prevention by making them
aware of the relationship between thoughts, emotions and symptomatology of the disorder. The exercises will also be used as a motivational work tool within a protocol of Acceptance and Commitment Therapy (ACT), a new generation cognitive behavioral approach, in which "commitment" components are added to mindfulness, suitable for lifestyle modification.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | All patients are assessed. The neuropsychologist assessed global cognitive status and disposition to Mindfulness. Engineered bands for multi-parameter heart rate monitoring were delivered.From the time of delivery, for 9 consecutive days the patient received a reminder via WhatsApp at the most convenient time slot. At this point, he would wear the supplied chest strap by wetting it appropriately so that it adhered perfectly to the skin. The heart rate App was accessed via Bluetooth and recorded the basal heart rate for about 10 minutes.Then the Mindfulness session was carried out. At the end of 9 days, the completed input tests plus the heart rate measurement were sent on day 10, except for the Mindfulness session, which was not scheduled. After two weeks, the measurement was repeated with the same procedure. Receives: Behavioral: ACT MINDFULNESS | |
| Group 2 | Patients in this group met the inclusion criteria and did not take any measurements. They underwent only the neuropsychological evaluation Receives: Behavioral: ACT MINDFULNESS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mindfulness Awareness Attention Scale MAAS
The Mindfulness Awareness Attention Scale measures an individual's tendency for mindfulness in an intentional way, based on the frequency in which he or she is mind-ful or mind-less in his or her experiences.
Measured: 15 DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start27 Jul 2022
- Primary completion27 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Marino, IRCCS Centro Neurolesi Bonino Pulejo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785260
- Sponsor's protocol ID
- BRAINHEART22
- Status last verified
- Mar 2023
- First submitted
- 13 Mar 2023
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting and Supporting Mental and Physical Well-being: the Role of Smart Health in the Prevention of Cerebrocardiovascular Disease
- ClinicalTrials.gov ID
- NCT05785260
- Acronym / sponsor ID
- BRAINHEART22
- Conditions
- Health Behavior, Healthy Lifestyle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 27 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 27 Mar 2023 (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.
The objective of the study is to develop a smartphone application dedicated to health prevention in terms of monitoring physical activity and healthy eating, mediated by the use of Mindfulness-ACT exercises to reduce unhealthy lifestyles and monitoring through the use of engineered wearable bands.
This is a nonpharmacological prospective observational study. The procedure includes consecutive enrollment in the study of 40 subjects who meet all inclusion criteria. Patients will undergo comprehensive cognitive assessment with collection of all medical history data and information on current clinical condition, including dietary lifestyle. After that they will be invited to register on Brainhearth platform, and then via the app monitoring of physical activity and nutrition, mediated by the use of Mindfulness-ACT exercises, will take place.
Detailed description
The Brainheart study aims to develop a smartphone application connected to a smartwatch dedicated to the prevention of cardiovascular disease among the elderly in their activities of daily living. In addition, to promote health by monitoring physical activity through special engineered bands and healthy eating, mediated by the use of Mindfulness-ACT exercises and appropriate dietary regimen, according to the attached scheme (Appendix A);to acquire physiological and behavioral correlates through the BRAINHEART platform;to develop physical activity, nutrition and interactive exercise programs based on MCBT and ACT; administering contextualized MCBT and ACT cognitive behavioral exercises to promote program adherence;enhancing meta-cognitive skills through a better understanding of the individual with respect to his or her own cognitive processes and their functioning;improving quality of life and one's mental and physical well-being;increasing scientific and clinical knowledge for mental and physical well-being and strategies to promote it;increasing sense of self-efficacy and self-esteem. To achieve these goals, the application developed on a mobile platform, will be designed by integrating:
- a multi-sensory wearable device capable of acquiring and processing physiological and behavioral data to monitor physical and mental health status
- advanced artificial intelligence-based decision support models that can recognize physical and mental health status and provide personalized physical activity and nutrition programs
- exercises and interactive games based on the cognitive behavioral technique Mindfulness and ACT, contextualized and customized in order to increase awareness of health status and motivate the elderly to pursue a healthy lifestyle and best follow the cerebrocardiovascular disease prevention program
STUDY DESIGN.
This is a nonpharmacological prospective observational study.
DURATION OF THE STUDY
Overall, the study will have a duration of 12 months.
STUDY POPULATION
A total of 40 subjects will be consecutively enrolled in the study who are afferent to the facility's outpatient clinics and meet all inclusion criteria, and who will be evaluated at the time of recruitment (T0), and at 6 (T1) and 12 months (T2) intervals. All patients will be assessed by the (a) MMSE, (b) batteries provided within the Brief Neuropsychological Examination, (c) quality of life assessment questionnaires, and (d) Mini Nutritional Assessment (see Annex A to this protocol).
Inclusion criteria
- Age of subjects: 50-85 years.
- Subjects with global cognitive functioning at normal limits (MMSE ≥ 20)
- Subjects with a diagnosis of mild and/or absent depression
Exclusion criteria.
- Diagnosis of dementia
- Diagnosis of moderate/severe depression
- Speech disorders;
- Psychiatric disorders;
- Praxic deficits.
Materials
The project involves the use of:
- portable devices with adequate computational and memory capabilities;
- wireless wearable sensors capable of simultaneously measuring heart rate (HR), and physical activity using triaxial accelerometer;
- mobile processing units for extraction of biosignal features and automatic classification of stress levels.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Behavioral: ACT MINDFULNESSAll patients are assessed. The neuropsychologist assessed global cognitive status and disposition to Mindfulness. Engineered bands for multi-parameter heart rate monitoring were delivered.From the time of delivery, for 9 consecutive days the patient received a reminder via WhatsApp at the most convenient time slot. At this point, he would wear the supplied chest strap by wetting it appropriately so that it adhered perfectly to the skin. The heart rate App was accessed via Bluetooth and recorded the basal heart rate for about 10 minutes.Then the Mindfulness session was carried out. At the end of 9 days, the completed input tests plus the heart rate measurement were sent on day 10, except for the Mindfulness session, which was not scheduled. After two weeks, the measurement was repeated with the same procedure. |
| Group 2 | – | Behavioral: ACT MINDFULNESSPatients in this group met the inclusion criteria and did not take any measurements. They underwent only the neuropsychological evaluation |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Forty subjects (20 adult subjects for the experimental group and 20 adult subjects for the control group) were recruited from the Bonino-Pulejo Neurolesi Center in Messina, Italy.
Key inclusion criteria (3 listed)
- Age of subjects: 50-85 years
- Subjects with global cognitive functioning at normal limits (mmse ≥ 20)
- Subjects with diagnosed mild and/or absent depression;
Key exclusion criteria (5 listed)
- Diagnosis of dementia
- Diagnosis of moderate/severe depression
- Language disorders
- Psychiatric disorders
- Praxic deficits.
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 |
|---|---|---|
| ACT MINDFULNESSMindfulness (MCBT) practices were offered to patients with the aim of fostering the elderly's pro-active role in health prevention by making them aware of the relationship between thoughts, emotions and symptomatology of the disorder. The exercises will also be used as a motivational work tool within a protocol of Acceptance and Commitment Therapy (ACT), a new generation cognitive behavioral approach, in which "commitment" components are added to mindfulness, suitable for lifestyle modification. | Behavioural | Group 1, Group 2 |
Primary outcome
Mindfulness Awareness Attention Scale MAAS
Time frame: 15 DAYS
The Mindfulness Awareness Attention Scale measures an individual's tendency for mindfulness in an intentional way, based on the frequency in which he or she is mind-ful or mind-less in his or her experiences.
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 27 Mar 2023.
- Individual participant dataSharing planned: No. Corresponding author
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Behavior and Healthy Lifestyle, run by IRCCS Centro Neurolesi Bonino Pulejo 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 5 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 27 Mar 2023. 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?
Mindfulness Awareness Attention Scale MAAS (time frame: 15 DAYS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2023.