- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02496728
NUYou:mHealth Intervention to Preserve and Promote Ideal Cardiovascular Health (NUYou)
American Heart Association Strategically Focused Research Network: mHealth Intervention to Preserve and Promote Ideal Cardiovascular Health
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Freshman college students at Northwestern University will be cluster randomized to two groups based on their dorm. The intervention for one group will target smoking, physical activity, BMI and consumption of fruits and vegetables. The intervention in the second group will target traveling behavior, sexual risk behaviors, sunscreen use and hydration. Baseline health and lifestyle measures will be assessed for each participant prior to intervention. Health assessments will measure height, weight, fasting glucose, total cholesterol and carbon monoxide. The lifestyle measure will ask questions about physical activity, diet, alcohol and tobacco use, safe sex practices, driving habits, and sunscreen use. These same measures will be repeated during the fall of the students' sophomore and junior years.
Participants will be given a mobile application and encouraged to track some behaviors. In addition, participants will be asked to answer weekly questions regarding health behaviors.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
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Illinois
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Chicago, Illinois, Forente stater, 60611
- Northwestern University
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Freshman at Northwestern University in the fall of 2015
- Live on campus
- Read, write and speak English
- Own an Iphone or Android smart phone
Exclusion Criteria:
- Pregnant or trying to become pregnant
- Established cardiovascular disease
- Unstable psychiatric or medical condition
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Cardiovascular Health
Participants will be given the results of their health assessment and feedback regarding their health behaviors and overall health.
Recommendations for change will be given if warranted.
Participants will download the study's mobile health application on their smartphone.
They will then be asked to report once a week about their health behaviors on the application.
Participants will also be asked to self-monitor health behaviors that are not already at ideal levels using the study application (environmental cues).
Participants will be asked to join a secret Facebook group where informational materials will be posted, participants can post about study health behaviors and social interaction around health behaviors can occur (social support and environmental cues).
|
An application on a smart phone that is designed to help individuals self-monitor health behaviors.
Text messages, informational posts and reminders supporting healthy behaviors.
Participants may interact with each other through a private Facebook group.
Educational materials regarding healthy behaviors.
|
|
Aktiv komparator: Whole Health
Participants will be given the results of their health assessment.
They will then receive educational materials about sunscreen use, safe sex, hydration and vehicular safety.
Participants will download the study's mobile health application on their smartphone.
They will then be asked to report once a week about their health behaviors on the application.
Participants will also be asked to self-monitor how much water they drink using the study application.
Participants will be asked to join a secret Facebook group where informational materials will be posted, they can post about study health behaviors and social interaction around health behaviors can occur (social support and environmental cues).
|
An application on a smart phone that is designed to help individuals self-monitor health behaviors.
Text messages, informational posts and reminders supporting healthy behaviors.
Participants may interact with each other through a private Facebook group.
Educational materials regarding healthy behaviors.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
American Heart Association MyLifeCheck (Simple 7) score as a measure of cardiovascular health
Tidsramme: 2 years
|
Participant's Simple 7 score is the sum of 7 cardiovascular health metrics attained at ideal levels as defined by American Heart Association.
1) physically active - Exercising at least 150 minutes of moderate or 75 minutes of vigorous physical activity per week.
2) Good diet quality - Eating 5 servings of fruits and vegetables per day, at least 3 servings of whole grain, and no more than 16 oz. of soda per day, rarely or never eats high sodium foods or processed meats.
3) nonsmoking - nonsmoker for at least a year.
4) not overweight - BMI < 25 kg/m2.
5) normoglycemic - fasting glucose < 100 mg/dl.
6) not hypercholesterolemic : total Cholesterol < 200 mg/dl.
7) not hypertensive.
Blood Pressure <120/<80.
|
2 years
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 14SFRN20480260
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .