High Impact Lifestyle Intervention in Adults with High Blood Pressure (

D
Daniel Clark

Primary Investigator

Administratively Closed
18 years - 100 years
All
Phase N/A
18 participants needed
1 Location

Brief description of study

The goal of Phase 1 is to assess the flow of the multistage inclusion screen and multifaceted intervention to support an anticipated NIA resubmission of a randomized clinical trial (RCT) testing the feasibility and initial efficacy of a high intensity lifestyle intervention (HILI) to improve or maintain cognition and ADRD biomarkers in African-American adults with hypertension and a family history of memory loss and thus at high risk for dementia. 

Detailed description of study

This phase serves to pilot a portion of the full study design for which NIA funding has been sought. For up to 18 subjects, the pilot includes modified recruitment, abbreviated study procedures, and only 1 interventional arm (out of the intended 4 arms) of the intended full study design. The goal of Phase 1 is to assess the flow of the multistage inclusion screen and multifaceted intervention to support an anticipated NIA resubmission of a randomized clinical trial (RCT) testing the feasibility and initial efficacy of a high impact lifestyle intervention (HILI) to improve or maintain cognition and ADRD biomarkers in African-American adults with hypertension and a family history of memory loss and thus at high risk for dementia. Phase 2 will be added to the protocol and submitted to IRB in the event funding is received.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: memory loss, dementia
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria:
  • 1.     English speaking
    2.     U.S. born
    3.     African-American
    4.     40-70 years
    5.     Ability to see and read street signs (self report)
Exclusion Criteria:
  • 1.     resistant HTN identified using the TRIUMPH definition (BP of ≥140/90 while on 4+ HTN medications or 3+ and on thiazide diuretic)
    2.     diagnosis of dementia or Alzheimer disease or mild cognitive impairment; Parkinson disease; brain tumor/infection/surgery; psychosis, schizophrenia, or bipolar disorder
    1. prescription of donepezil,vastigmine, galantamine, or memantine, past or present
    2. unable tohe Exercise Assessment and Screening for You (EASY), or receivevider clearance for exercise
    3. alcohol consumption ≥ 8 drinks perweek for women, or ≥15 drinks per week for men
    4. changing/unstable residence tove food deliveries

Updated on 01 Aug 2024. Study ID: 2006147911, NTM-IIR-HILI

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