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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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).
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Laura Korthauer, Ph.D.
- Telefonní číslo: 715-797-3513
- E-mail: laura_korthauer@brown.edu
Studijní záloha kontaktů
- Jméno: Jennifer Davis, Ph.D.
- E-mail: jdavis3@brownhealth.org
Studijní místa
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Rhode Island
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Providence, Rhode Island, Spojené státy, 02903-4923
- Rhode Island Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Aktivní komparátor: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Multidomain behavioral composite
Časové okno: baseline, 2 months (end of treatment), 4 months, 12 months
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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)
Časové okno: 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
Časové okno: 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
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Wearable measurement of moderate/vigorous physical activity minutes
Časové okno: 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
Časové okno: 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
Časové okno: 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
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Mediterranean Diet Adherence Tool
Časové okno: baseline, 2 months (end of treatment), 4 months, 12 months
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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
Časové okno: baseline, 2 months (end of treatment), 4 months, 12 months
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standardized assessment of cognitive activities (self-report) |
baseline, 2 months (end of treatment), 4 months, 12 months
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Consensus Sleep Diary
Časové okno: 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
Časové okno: baseline, 2 months (end of treatment), 4 months, 12 months
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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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: baseline, 2 months (end of treatment), 4 months, 12 months
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systolic blood pressure (average of 3 measurements) |
baseline, 2 months (end of treatment), 4 months, 12 months
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Hemoglobin A1C
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Onemocnění endokrinního systému
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Nemoci nervového systému
- Cévní onemocnění
- Kardiovaskulární choroby
- Duševní poruchy
- Metabolické choroby
- Neurokognitivní poruchy
- Poruchy metabolismu glukózy
- Demence
- Tauopatie
- Neurodegenerativní onemocnění
- Chování
- Nutriční a metabolické nemoci
- Hypertenze
- Alzheimerova nemoc
- Diabetes Mellitus
- Motorická aktivita
- Zdravotní chování
Další identifikační čísla studie
- BUH1-2369821
- R01AG093970 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
All de-identified IPD will be shared, consistent with the NIH Data Management and Sharing Policy
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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