Promoting Mental and Physical Well-being Through Smart Health

NCT05785260 | Completed

• 1 other identifier: BRAINHEART22
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Health Behavior; Healthy Lifestyle

Outcome Measures

Primary Outcomes (1)

• 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.

  15 DAYS

Study Arms (2)

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.

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

Behavioral: ACT MINDFULNESS

Interventions

ACT MINDFULNESS BEHAVIORAL

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.

Group 1; Group 2

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• \- Age of subjects: 50-85 years
• Subjects with global cognitive functioning at normal limits (mmse ≥ 20)
• Subjects with diagnosed mild and/or absent depression;

You may not qualify if:

• Diagnosis of dementia
• Diagnosis of moderate/severe depression
• Language disorders
• Psychiatric disorders
• Praxic deficits.

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

IRCCS Centro Neurolesi "Bonino-Pulejo"

Messina, 98124, Italy

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 27, 2023
• Study Start: July 27, 2022
• Primary Completion: December 27, 2022
• Study Completion: December 31, 2022
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)