- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
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Illinois
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Chicago, Illinois, États-Unis, 60611
- Northwestern University
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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.
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
American Heart Association MyLifeCheck (Simple 7) score as a measure of cardiovascular health
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 14SFRN20480260
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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