Gray Matters Alzheimer's Disease Prevention Intervention
2. desember 2015 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
146
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år til 64 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Styre
Ingen inngrep
|
|
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Eksperimentell: Treatment
Health education program; informational website, experiential classes in various help domains, custom smart phone application, and wearable technology
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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).
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Maria C Norton, PhD, Utah State University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2014
Primær fullføring (Faktiske)
1. desember 2014
Studiet fullført (Faktiske)
1. desember 2014
Datoer for studieregistrering
Først innsendt
6. november 2014
Først innsendt som oppfylte QC-kriteriene
10. november 2014
Først lagt ut (Anslag)
14. november 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
3. desember 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. desember 2015
Sist bekreftet
1. desember 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 5606
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