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NUYou:mHealth Intervention to Preserve and Promote Ideal Cardiovascular Health (NUYou)

17. maj 2019 opdateret af: Bonnie Spring, Northwestern University

American Heart Association Strategically Focused Research Network: mHealth Intervention to Preserve and Promote Ideal Cardiovascular Health

The purpose of the study is to investigate the preservation or promotion of health in students during the college years.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

302

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University

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

17 år til 26 år (Barn, Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

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

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
Eksperimentel: 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).
Adfærdsmæssigt: Mobile Health Application
An application on a smart phone that is designed to help individuals self-monitor health behaviors.
Adfærdsmæssigt: Environmental Cues
Text messages, informational posts and reminders supporting healthy behaviors.
Adfærdsmæssigt: Social Support
Participants may interact with each other through a private Facebook group.
Adfærdsmæssigt: Educational Materials
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).
Adfærdsmæssigt: Mobile Health Application
An application on a smart phone that is designed to help individuals self-monitor health behaviors.
Adfærdsmæssigt: Environmental Cues
Text messages, informational posts and reminders supporting healthy behaviors.
Adfærdsmæssigt: Social Support
Participants may interact with each other through a private Facebook group.
Adfærdsmæssigt: Educational Materials
Educational materials regarding healthy behaviors.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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

Sponsor

Northwestern University

Samarbejdspartnere

American Heart Association

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. maj 2015

Primær færdiggørelse (Faktiske)

28. februar 2019

Studieafslutning (Faktiske)

28. februar 2019

Datoer for studieregistrering

Først indsendt

29. maj 2015

Først indsendt, der opfyldte QC-kriterier

9. juli 2015

Først opslået (Skøn)

14. juli 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. maj 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. maj 2019

Sidst verificeret

1. maj 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 14SFRN20480260

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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 .

Kliniske forsøg med Kardiovaskulær sygdom

Kliniske forsøg med Mobile Health Application

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Sponsorer og samarbejdspartnere

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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