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Gray Matters Alzheimer's Disease Prevention Intervention

2. december 2015 opdateret af: Maria C Norton, PhD, Utah State University

Gray Matters: Multi-domain Lifestyle Behavioral Alzheimer's Disease Prevention Randomized Controlled Trial

This is a randomized controlled trial to develop and test the efficacy of a multi-domain lifestyle behavioral intervention designed to promote healthier lifestyle behaviors linked to lower Alzheimer's disease risk among persons aged 40 to 64 years.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a randomized controlled trial to develop and test the efficacy of a multi-domain lifestyle behavioral intervention designed to promote healthier lifestyle behaviors linked to lower Alzheimer's disease risk among persons aged 40 to 64 years. Participants are randomized to treatment or control condition. The intervention, spanning a six month period, is an evidence-based health education program.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

146

Fase

  • Ikke anvendelig

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 64 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age
  • Residing or working in Cache County Utah
  • Possessing smart phone or tablet

Exclusion Criteria:

  • Dementia
  • Pregnancy
  • Untreated chronic major depression or other psychiatric condition
  • Body mass index > 41
  • Heart or stroke in prior 6 weeks
  • Active cancer treatment
  • Unwillingness to seek medical help when serious condition identified at intake

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Styring
Ingen indgriben
Eksperimentel: Treatment
Health education program; informational website, experiential classes in various help domains, custom smart phone application, and wearable technology
Adfærdsmæssigt: Health education program
The intervention is a health education program including: informational website, experiential classes, custom smart phone or smart table application, wearable activity monitor, and informal coaching by student researchers to provide moral support for lifestyle behavioral change goals. Participants are not placed on any specific behavioral regimen but instead are encouraged to adopt healthier lifestyle behaviors per the evidence-based health education program, and to attend the experiential classes "cafeteria style" (i.e. based on their individual preferences).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Picture Vocabulary
Tidsramme: up to 7 months
Picture Vocabulary cognitive test score
up to 7 months
Flanker Inhibitory Control and Attention Test
Tidsramme: up to 7 months
Flanker Inhibitory Control and Attention Test cognitive test score
up to 7 months
List Sorting Working Memory Test
Tidsramme: up to 7 months
List Sorting Working Memory Test cognitive test score
up to 7 months
Oral Symbol Digit Test
Tidsramme: up to 7 months
Oral Symbol Digit Test cognitive test score
up to 7 months
Montreal Cognitive Assessment
Tidsramme: up to 7 months
Montreal Cognitive Assessment test score
up to 7 months
Rey Auditory Verbal Learning Test
Tidsramme: up to 7 months
Rey Auditory Verbal Learning Test score
up to 7 months
Controlled Oral Word Association Test
Tidsramme: up to 7 months
Controlled Oral Word Association Test score
up to 7 months
Blood pressure
Tidsramme: up to 7 months
Systolic and diastolic blood pressure
up to 7 months
Body mass index
Tidsramme: up to 7 months
Height and weight measurement for computing body mass index
up to 7 months
Insulin
Tidsramme: up to 7 months
insulin from venipuncture blood sample
up to 7 months
Systemic inflammation
Tidsramme: up to 7 months
C-reactive protein from venipuncture blood sample
up to 7 months
Skin carotenoid status
Tidsramme: up to 7 months
Biophotonic device that shines a light-emitting diode (LED) light at a site on the palm, to measure the skin carotenoid level in units of Raman counts
up to 7 months
Triglycerides
Tidsramme: up to 7 months
triglycerides from venipuncture blood sample
up to 7 months
HDL Cholesterol
Tidsramme: up to 7 months
High-density lipoprotein from venipuncture blood sample
up to 7 months
LDL Cholesterol
Tidsramme: up to 7 months
Low-density lipoprotein from venipuncture blood sample
up to 7 months
Total cholesterol
Tidsramme: up to 7 months
Total cholesterol from venipuncture blood sample
up to 7 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Depression
Tidsramme: up to 7 months
Center for Epidemiologic Studies - Depression scale score
up to 7 months
Motivation
Tidsramme: up to 7 months
Situational Motivation Scale score
up to 7 months
Sleep Quality
Tidsramme: up to 7 months
Pittsburgh Sleep Quality Index scale score
up to 7 months
Stress
Tidsramme: up to 7 months
Perceived Stress Scale score
up to 7 months
Emotional Support
Tidsramme: up to 7 months
Emotional Support subscale from the NIH Toolbox measures for social engagement
up to 7 months
Friendship
Tidsramme: up to 7 months
Friendship subscale from the NIH Toolbox measures for social engagement
up to 7 months
Hostility
Tidsramme: up to 7 months
Hostility subscale from the NIH Toolbox measures for social engagement
up to 7 months
Loneliness
Tidsramme: up to 7 months
Loneliness subscale from the NIH Toolbox measures for social engagement
up to 7 months
Physical Activity - Moderate
Tidsramme: up to 7 months
self-report question concerning # minutes per day doing moderate intensity physical activity (per Center for Disease Control definition)
up to 7 months
Physical Activity - Vigorous
Tidsramme: up to 7 months
self-report question concerning # minutes per day doing vigorous intensity physical activity (per Center for Disease Control definition)
up to 7 months
Nutrition
Tidsramme: up to 7 months
Diet History Questionnaire
up to 7 months
Readiness for Change
Tidsramme: up to 7 months
Revised University of Rhode Island Change Assessment (R-URICA) readiness for change scale
up to 7 months
Metacognition
Tidsramme: up to 7 months
Total score from a set of seven items (1=much worse to 5=much better), comparing current memory to how it was three years ago, adapted from a questionnaire of functional ability
up to 7 months

Samarbejdspartnere og efterforskere

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

Sponsor

Utah State University

Efterforskere

  • Ledende efterforsker: Maria C Norton, PhD, Utah State University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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

1. april 2014

Primær færdiggørelse (Faktiske)

1. december 2014

Studieafslutning (Faktiske)

1. december 2014

Datoer for studieregistrering

Først indsendt

6. november 2014

Først indsendt, der opfyldte QC-kriterier

10. november 2014

Først opslået (Skøn)

14. november 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

3. december 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. december 2015

Sidst verificeret

1. december 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 5606

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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