My Healthy Brain: Preserving and Promoting Brain Health Through Evidence-based Practices

NCT ID: NCT04537728

Last Updated: 2022-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-12-31

Brief Summary

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The objective of this trial is to demonstrate early proof-of-concept for My Healthy Brain, an 8-week group program that directly targets multiple lifestyle factors associated with brain health and prevention of cognitive decline. The investigators will explore the feasibility, acceptability, and effect sizes of improvement in primary lifestyle outcomes as well as secondary outcomes of self-determination and subjective well-being.

Detailed Description

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Conditions

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Aging Mild Cognitive Impairment Dementia Old Age; Dementia Cognitive Decline

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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My Healthy Brain Version 2

an 8-week group program that directly targets multiple lifestyle factors associated with brain health and prevention of CD

Group Type EXPERIMENTAL

My Healthy Brain Version 2

Intervention Type BEHAVIORAL

multimodal lifestyle intervention incorporating mindfulness skills, behavioral principles, and recent research on brain disease risk factors

Interventions

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My Healthy Brain Version 2

multimodal lifestyle intervention incorporating mindfulness skills, behavioral principles, and recent research on brain disease risk factors

Intervention Type BEHAVIORAL

Other Intervention Names

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MHBv2

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 60 years
* English fluency/literacy
* ≥1 modifiable brain disease risk factor (outlined by JAMA)
* Bluetooth 4.0 enabled smartphone

Exclusion Criteria

* Diagnosis of dementia; Montreal Cognitive Assessment \< 18
* Serious medical illness expected to worsen in next 6 months
* Current suicidal ideation
* Substance abuse
* Untreated serious mental health conditions
* Current use of digital monitoring device (eg. Fitbit)
* Mindfulness practice (\> 45 minutes/week) in the last three months
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ana-Maria Vranceanu, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ana-Maria Vranceanu, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Schroeder MW, Frumkin MR, Mace RA. Proof-of-concept for integrating multimodal digital health assessments into lifestyle interventions for older adults with dementia risk factors. J Behav Med. 2025 Apr;48(2):373-384. doi: 10.1007/s10865-024-00546-7. Epub 2025 Jan 20.

Reference Type DERIVED
PMID: 39833389 (View on PubMed)

Other Identifiers

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2019P003657

Identifier Type: -

Identifier Source: org_study_id

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