Gray Matters Alzheimer's Disease Prevention Intervention
2 december 2015 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
146
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
40 år till 64 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Kontrollera
Inget ingripande
|
|
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Experimentell: 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).
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Picture Vocabulary
Tidsram: up to 7 months
|
Picture Vocabulary cognitive test score
|
up to 7 months
|
|
Flanker Inhibitory Control and Attention Test
Tidsram: up to 7 months
|
Flanker Inhibitory Control and Attention Test cognitive test score
|
up to 7 months
|
|
List Sorting Working Memory Test
Tidsram: up to 7 months
|
List Sorting Working Memory Test cognitive test score
|
up to 7 months
|
|
Oral Symbol Digit Test
Tidsram: up to 7 months
|
Oral Symbol Digit Test cognitive test score
|
up to 7 months
|
|
Montreal Cognitive Assessment
Tidsram: up to 7 months
|
Montreal Cognitive Assessment test score
|
up to 7 months
|
|
Rey Auditory Verbal Learning Test
Tidsram: up to 7 months
|
Rey Auditory Verbal Learning Test score
|
up to 7 months
|
|
Controlled Oral Word Association Test
Tidsram: up to 7 months
|
Controlled Oral Word Association Test score
|
up to 7 months
|
|
Blood pressure
Tidsram: up to 7 months
|
Systolic and diastolic blood pressure
|
up to 7 months
|
|
Body mass index
Tidsram: up to 7 months
|
Height and weight measurement for computing body mass index
|
up to 7 months
|
|
Insulin
Tidsram: up to 7 months
|
insulin from venipuncture blood sample
|
up to 7 months
|
|
Systemic inflammation
Tidsram: up to 7 months
|
C-reactive protein from venipuncture blood sample
|
up to 7 months
|
|
Skin carotenoid status
Tidsram: 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
Tidsram: up to 7 months
|
triglycerides from venipuncture blood sample
|
up to 7 months
|
|
HDL Cholesterol
Tidsram: up to 7 months
|
High-density lipoprotein from venipuncture blood sample
|
up to 7 months
|
|
LDL Cholesterol
Tidsram: up to 7 months
|
Low-density lipoprotein from venipuncture blood sample
|
up to 7 months
|
|
Total cholesterol
Tidsram: up to 7 months
|
Total cholesterol from venipuncture blood sample
|
up to 7 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Depression
Tidsram: up to 7 months
|
Center for Epidemiologic Studies - Depression scale score
|
up to 7 months
|
|
Motivation
Tidsram: up to 7 months
|
Situational Motivation Scale score
|
up to 7 months
|
|
Sleep Quality
Tidsram: up to 7 months
|
Pittsburgh Sleep Quality Index scale score
|
up to 7 months
|
|
Stress
Tidsram: up to 7 months
|
Perceived Stress Scale score
|
up to 7 months
|
|
Emotional Support
Tidsram: up to 7 months
|
Emotional Support subscale from the NIH Toolbox measures for social engagement
|
up to 7 months
|
|
Friendship
Tidsram: up to 7 months
|
Friendship subscale from the NIH Toolbox measures for social engagement
|
up to 7 months
|
|
Hostility
Tidsram: up to 7 months
|
Hostility subscale from the NIH Toolbox measures for social engagement
|
up to 7 months
|
|
Loneliness
Tidsram: up to 7 months
|
Loneliness subscale from the NIH Toolbox measures for social engagement
|
up to 7 months
|
|
Physical Activity - Moderate
Tidsram: 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
Tidsram: 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
Tidsram: up to 7 months
|
Diet History Questionnaire
|
up to 7 months
|
|
Readiness for Change
Tidsram: up to 7 months
|
Revised University of Rhode Island Change Assessment (R-URICA) readiness for change scale
|
up to 7 months
|
|
Metacognition
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Maria C Norton, PhD, Utah State University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2014
Primärt slutförande (Faktisk)
1 december 2014
Avslutad studie (Faktisk)
1 december 2014
Studieregistreringsdatum
Först inskickad
6 november 2014
Först inskickad som uppfyllde QC-kriterierna
10 november 2014
Första postat (Uppskatta)
14 november 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
3 december 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 december 2015
Senast verifierad
1 december 2015
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 5606
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .