The Brain Health Champion Study

NCT03772977 | Active Not Recruiting

• 1 other identifier: 2017P000384
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

6-month, randomized, controlled investigation measuring the effect of increased clinical contact and personalization compared to standard physician counseling on adherence to consensus-based, brain health recommendations for patients with subjective cognitive decline, mild cognitive impairment, and early dementia or patients who are at risk for developing these conditions.

Conditions

Mild Cognitive Impairment; Dementia, Mild; Subjective Cognitive Decline; At Risk for Cognitive Decline

Keywords

mild cognitive impairment; dementia risk reduction; brain health

Outcome Measures

Primary Outcomes (3)

• Self-report adherence to Mediterranean diet

  Goulet Mediterranean Diet Score (questionnaire). Measured adherence to the Mediterranean Diet. Likert Scale 0-44, with higher values indicating stronger adherence to the dietary pattern.

  6 months

• Self-report participation in cognitive and socially stimulating activities

  Florida Cognitive Activities Scale (questionnaire). Measures participation in socially and cognitively stimulating activities. Likert Scale 0-180, with higher values indicating greater participation.

  6 months

• Self-report exercise and physical activity

  Physical Activity Scale for the Elderly (questionnaire). Measures walking, moderate, and vigorous activity. Zero lower limit, no upper limit. Higher values indicate more physical activity.

  6 months

Secondary Outcomes (4)

• Quality of Life Self-Report

  6 months

• Neuropsychiatric status

  6 months

• Cognitive function

  6 months

• Sleep

  6 months

Study Arms (2)

Brain Health Champion (BHC)

EXPERIMENTAL

A "health coach" intervention with weekly phone calls

Behavioral: Brain Health Champion

Standard of Care (SOC)

NO INTERVENTION

The current physician/provider counseling on brain health to reduce cognitive decline or incidence of cognitive impairment that occurs, per providers' own practice

Interventions

Brain Health Champion BEHAVIORAL

A health coach embedded within an existing clinical care team

Brain Health Champion (BHC)

Eligibility Criteria

• Age: 60 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be age 60 to 79
• Existing patient at Brigham Health system with at least one prior visit with providers and plans to establish/continue longitudinal care
• Be sufficiently fluent in the English language to understand instructions and perform the cognitive and functional tests
• For neurology participants only: Have a diagnosis of Subjective Cognitive Disorder (SCD) (MMSE guideline 27-30), Mild Cognitive Impairment (MCI) due to Alzheimer disease (AD), cerebrovascular disease (CVD), or mixed-type AD/CVD (MMSE guideline 24-30), or mild dementia due to AD, CVD, or mixed-AD/CVD (MMSE guideline 20-30). In some cases, based on the clinical judgment of the treating neurologist, we may enroll a patient who falls outside of these guidelines or whose diagnosis and overall level of functioning does not perfectly correlate to their MMSE score.
• For primary care participants only: Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) dementia risk score of ≥ 6, or score of 5 plus one of the following: a history of ADRD in a first-degree relative, or type II diabetes or "pre-diabetes" spectrum (A1C level ≥ 5.7)

You may not qualify if:

• Be enrolled in another health behavior or non-pharmacologic intervention for a neurocognitive disorder
• Be unable to or unwilling to carry out regular physical exercise, multiple times weekly.
• Be not recommended to participate by their Internist/Primary Care Provider due to health-related concerns.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital, Department of Neurology

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Schwartz HEM, Bay CP, McFeeley BM, Krivanek TJ, Daffner KR, Gale SA. The Brain Health Champion study: Health coaching changes behaviors in patients with cognitive impairment. Alzheimers Dement (N Y). 2019 Nov 12;5:771-779. doi: 10.1016/j.trci.2019.09.008. eCollection 2019.

  PMID: 31763431 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Seth A Gale, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Neurologist, Assistant Professor of Neurology

Study Record Dates

• First Submitted: November 25, 2018
• First Posted: December 12, 2018
• Study Start: May 8, 2017
• Primary Completion: July 1, 2024
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)