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)

November 6, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Estimated)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903-4923
        • Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental

TEACH Intervention
Behavioral: 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.
Active Comparator: Control

Basic Health Education
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multidomain behavioral composite
Time Frame: 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)
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wearable measurement of moderate/vigorous physical activity minutes
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: baseline, 2 months (end of treatment), 4 months, 12 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rhode Island Hospital

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2027

Primary Completion (Estimated)

February 1, 2031

Study Completion (Estimated)

September 30, 2031

Study Registration Dates

First Submitted

November 6, 2026

First Submitted That Met QC Criteria

November 6, 2026

First Posted (Actual)

November 12, 2026

Study Record Updates

Last Update Posted (Actual)

November 12, 2026

Last Update Submitted That Met QC Criteria

November 6, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUH1-2369821
  • R01AG093970 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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