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)
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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).
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Laura Korthauer, Ph.D.
- 전화번호: 715-797-3513
- 이메일: laura_korthauer@brown.edu
연구 연락처 백업
- 이름: Jennifer Davis, Ph.D.
- 이메일: jdavis3@brownhealth.org
연구 장소
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Rhode Island
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Providence, Rhode Island, 미국, 02903-4923
- Rhode Island Hospital
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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Age 40-69 years
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Normal cognition (Telephone Interview for Cognitive Status-Modified > 32)
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English language fluency
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Participants must have at least two of six dementia risk factors:
- BMI in the overweight or obesity range ( >24.9)
- Systolic blood pressure in the "elevated" range or higher (>120 mmHg)
- LDL cholesterol outside the "optimal" range (>100 mg/dL)
- HbA1C in the prediabetes or diabetes range (> 5.6%)
- APOE e4 allele
- First-degree relative with ADRD
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Participants must have suboptimal engagement in at least one core health behavior:
- Diet: Mediterranean Diet Adherence Screener (MEDAS) total score < 10
- Physical activity: <120 minutes of moderate-intensity or <60 minutes of vigorous-intensity physical activity per week
- Sleep: <=7 hours of sleep per night (past-week average)
Exclusion Criteria:
- History of serious mental illness (i.e., schizophrenia, bipolar disorder)
- Current Beck Depression Inventory score > 28
- Prior diagnosis of Mild or Major Neurocognitive Disorder
- History of neurodevelopmental disorder (e.g., intellectual disability)
- Severe physical disability or unstable medical conditions that prevent safe engagement in recommended study activities (e.g., physical activity)
- Current alcohol or substance use disorder based on self-report
- Current enrollment in an ADRD prevention clinical trial.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Experimental
TEACH Intervention |
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. |
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활성 비교기: Control
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Multidomain behavioral composite
기간: 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
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Metabolic Syndrome Severity Score (MetS severity)
기간: baseline, 2 months (end of treatment), 4 months, 12 months
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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
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Dementia SomaSignal Test
기간: baseline, 2 months (end of treatment), 12 months
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Proteomic ADRD risk index that predicts 20-year risk of dementia from middle age |
baseline, 2 months (end of treatment), 12 months
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Wearable measurement of moderate/vigorous physical activity minutes
기간: baseline, 2 months (end of treatment), 4 months, 12 months
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7-day average of moderate to vigorous physical activity minutes, collected via wearable |
baseline, 2 months (end of treatment), 4 months, 12 months
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Step count
기간: baseline, 2 months (end of treatment), 4 months, 12 months
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7-day average step count, collected via wearable |
baseline, 2 months (end of treatment), 4 months, 12 months
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Total sleep time
기간: baseline, 2 months (end of treatment), 4 months, 12 months
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7-day average total sleep time, collected via wearable |
baseline, 2 months (end of treatment), 4 months, 12 months
|
|
Mediterranean Diet Adherence Tool
기간: 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
|
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Florida Cognitive Activities Scale
기간: 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
|
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Consensus Sleep Diary
기간: 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
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International Physical Activities Scale
기간: 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
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Perceived Threat of ADRD
기간: baseline, 2 months (end of treatment), 4 months, 12 months
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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
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Dementia Awareness Questionnaire
기간: baseline, 2 months (end of treatment), 4 months, 12 months
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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
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Motivation to Change Behavior for Dementia Risk Reduction (MOCHAD-10)
기간: baseline, 2 months (end of treatment), 4 months, 12 months
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self-report measure of self-efficacy pertaining to behaviors for dementia risk reduction |
baseline, 2 months (end of treatment), 4 months, 12 months
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Body Weight
기간: baseline, 2 months (end of treatment), 4 months, 12 months
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body weight |
baseline, 2 months (end of treatment), 4 months, 12 months
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Waist circumference
기간: baseline, 2 months (end of treatment), 4 months, 12 months
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waist circumference (cm) |
baseline, 2 months (end of treatment), 4 months, 12 months
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Lipid panel
기간: baseline, 2 months (end of treatment), 4 months, 12 months
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Obtained via fasting blood draw. Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides. |
baseline, 2 months (end of treatment), 4 months, 12 months
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Systolic blood pressure
기간: 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
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Hemoglobin A1C
기간: baseline, 2 months (end of treatment), 4 months, 12 months
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Glycated hemoglobin, a measure of average blood sugar over the past 2-3 months |
baseline, 2 months (end of treatment), 4 months, 12 months
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공동 작업자 및 조사자
협력자
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- BUH1-2369821
- R01AG093970 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
All de-identified IPD will be shared, consistent with the NIH Data Management and Sharing Policy
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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