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Tailored Education for Aging and Cognitive Health: A Health Behavior Change Intervention for Midlife Adults at Risk for Alzheimer's Disease and Related Dementias (TEACH)

6. november 2026 opdateret af: Rhode Island Hospital

Testing the Efficacy of a Personalized Multi-Domain Behavioral Intervention for Alzheimer's Disease and Related Dementias Risk Reduction in Midlife

This Stage II behavioral intervention development project will examine the efficacy of a multi-domain health behavior intervention for primary prevention of Alzheimer's disease and related dementias (ADRD) in middle age.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The 8-week, remotely-delivered TEACH intervention was designed to promote maintenance, not just initiation, of health behaviors that reduce risk for ADRD. This randomized controlled trial (N=140 per arm; 1:1 allocation) will examine the efficacy of TEACH versus basic health education alone at end of treatment (8 weeks) and 4- and 12-month follow-up. We will examine the efficacy of the intervention on a multidomain behavioral composite score and individual health behaviors related to dementia risk (Aim 1) and biological outcomes including metabolic syndrome severity and a proteomic dementia risk score (Aim 2). We will also examine behavioral mediators of treatment effects on biological outcomes (how the intervention works) and its possible moderators (who benefits the most; Aim 3).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

280

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02903-4923
        • Rhode Island Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år til 69 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Age 40-69 years

  2. Normal cognition (Telephone Interview for Cognitive Status-Modified > 32)

  3. English language fluency

  4. Participants must have at least two of six dementia risk factors:

    1. BMI in the overweight or obesity range ( >24.9)
    2. Systolic blood pressure in the "elevated" range or higher (>120 mmHg)
    3. LDL cholesterol outside the "optimal" range (>100 mg/dL)
    4. HbA1C in the prediabetes or diabetes range (> 5.6%)
    5. APOE e4 allele
    6. First-degree relative with ADRD

  5. Participants must have suboptimal engagement in at least one core health behavior:

    1. Diet: Mediterranean Diet Adherence Screener (MEDAS) total score < 10
    2. Physical activity: <120 minutes of moderate-intensity or <60 minutes of vigorous-intensity physical activity per week
    3. Sleep: <=7 hours of sleep per night (past-week average)

Exclusion Criteria:

  1. History of serious mental illness (i.e., schizophrenia, bipolar disorder)
  2. Current Beck Depression Inventory score > 28
  3. Prior diagnosis of Mild or Major Neurocognitive Disorder
  4. History of neurodevelopmental disorder (e.g., intellectual disability)
  5. Severe physical disability or unstable medical conditions that prevent safe engagement in recommended study activities (e.g., physical activity)
  6. Current alcohol or substance use disorder based on self-report
  7. Current enrollment in an ADRD prevention clinical trial.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Experimental

TEACH Intervention
Adfærdsmæssigt: TEACH

The TEACH intervention provides a personalized assessment of and education about ADRD risk factors and health belief traits that are evidence-based moderators of behavior change. The 8-week, remotely delivered group intervention educates participants about 16 modifiable risk factors for ADRD. TEACH includes a personalized goal-setting process and education about health beliefs that are barriers or facilitators of behavior change.
Aktiv komparator: Control

Basic Health Education
Adfærdsmæssigt: Basic health education

The basic health education is an 8-week, remotely delivered group intervention that educates participants about 16 modifiable risk factors for ADRD.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Multidomain behavioral composite
Tidsramme: baseline, 2 months (end of treatment), 4 months, 12 months

This multidomain behavioral composite score is an unweighted average of five individual health behaviors: physical activity, Mediterranean diet adherence, cognitive activity, sleep quality, and alcohol use. Z-scores (or robust z-scores based on median/median absolute deviation for non-normal variables) for each continuous component score at baseline are calculated. Individual measures include 7-day average of moderate/vigorous physical activity measured via wearable (physical activity, total sleep time), Mediterranean Diet Adherence Tool total score (diet), Florida Cognitive Activities Scale (cognitive activity), and average units of alcohol consumed in the past two weeks (alcohol).
baseline, 2 months (end of treatment), 4 months, 12 months
Metabolic Syndrome Severity Score (MetS severity)
Tidsramme: baseline, 2 months (end of treatment), 4 months, 12 months

Race- and sex-specific weighted z-score based on confirmatory factor analysis from NHANES data (Gurka et al., 2012, 2014). MetS severity score is based on waist circumference, blood pressure, triglycerides, HDL cholesterol, and fasting plasma glucose
baseline, 2 months (end of treatment), 4 months, 12 months
Dementia SomaSignal Test
Tidsramme: baseline, 2 months (end of treatment), 12 months

Proteomic ADRD risk index that predicts 20-year risk of dementia from middle age
baseline, 2 months (end of treatment), 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Wearable measurement of moderate/vigorous physical activity minutes
Tidsramme: baseline, 2 months (end of treatment), 4 months, 12 months

7-day average of moderate to vigorous physical activity minutes, collected via wearable
baseline, 2 months (end of treatment), 4 months, 12 months
Step count
Tidsramme: baseline, 2 months (end of treatment), 4 months, 12 months

7-day average step count, collected via wearable
baseline, 2 months (end of treatment), 4 months, 12 months
Total sleep time
Tidsramme: baseline, 2 months (end of treatment), 4 months, 12 months

7-day average total sleep time, collected via wearable
baseline, 2 months (end of treatment), 4 months, 12 months
Mediterranean Diet Adherence Tool
Tidsramme: baseline, 2 months (end of treatment), 4 months, 12 months

standardized assessment of adherence to the Mediterranean diet (self-report)
baseline, 2 months (end of treatment), 4 months, 12 months
Florida Cognitive Activities Scale
Tidsramme: baseline, 2 months (end of treatment), 4 months, 12 months

standardized assessment of cognitive activities (self-report)
baseline, 2 months (end of treatment), 4 months, 12 months
Consensus Sleep Diary
Tidsramme: baseline, 2 months (end of treatment), 4 months, 12 months

standardized assessment of sleep quantity and quality (self-report)
baseline, 2 months (end of treatment), 4 months, 12 months
International Physical Activities Scale
Tidsramme: baseline, 2 months (end of treatment), 4 months, 12 months

standardized assessment of types and intensity of physical activity and sitting time that people do as part of their daily lives. This can be used to estimate total activity in MET-min/week and time spent sitting.
baseline, 2 months (end of treatment), 4 months, 12 months
Perceived Threat of ADRD
Tidsramme: baseline, 2 months (end of treatment), 4 months, 12 months

perceived threat and susceptibility of Alzheimer's disease and related dementias (7-item Likert scale)
baseline, 2 months (end of treatment), 4 months, 12 months
Dementia Awareness Questionnaire
Tidsramme: baseline, 2 months (end of treatment), 4 months, 12 months

standardized self-report measure of dementia knowledge, including knowledge of modifiable risk factors for ADRD
baseline, 2 months (end of treatment), 4 months, 12 months
Motivation to Change Behavior for Dementia Risk Reduction (MOCHAD-10)
Tidsramme: baseline, 2 months (end of treatment), 4 months, 12 months

self-report measure of self-efficacy pertaining to behaviors for dementia risk reduction
baseline, 2 months (end of treatment), 4 months, 12 months
Body Weight
Tidsramme: baseline, 2 months (end of treatment), 4 months, 12 months

body weight
baseline, 2 months (end of treatment), 4 months, 12 months
Waist circumference
Tidsramme: baseline, 2 months (end of treatment), 4 months, 12 months

waist circumference (cm)
baseline, 2 months (end of treatment), 4 months, 12 months
Lipid panel
Tidsramme: baseline, 2 months (end of treatment), 4 months, 12 months

Obtained via fasting blood draw. Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides.
baseline, 2 months (end of treatment), 4 months, 12 months
Systolic blood pressure
Tidsramme: baseline, 2 months (end of treatment), 4 months, 12 months

systolic blood pressure (average of 3 measurements)
baseline, 2 months (end of treatment), 4 months, 12 months
Hemoglobin A1C
Tidsramme: baseline, 2 months (end of treatment), 4 months, 12 months

Glycated hemoglobin, a measure of average blood sugar over the past 2-3 months
baseline, 2 months (end of treatment), 4 months, 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Rhode Island Hospital

Samarbejdspartnere

Brown University
The Miriam Hospital
National Institute on Aging (NIA)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. februar 2027

Primær færdiggørelse (Anslået)

1. februar 2031

Studieafslutning (Anslået)

30. september 2031

Datoer for studieregistrering

Først indsendt

6. november 2026

Først indsendt, der opfyldte QC-kriterier

6. november 2026

Først opslået (Faktiske)

12. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BUH1-2369821
  • R01AG093970 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

All de-identified IPD will be shared, consistent with the NIH Data Management and Sharing Policy

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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