- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02031185
A Wearable mHealth Device to Promote Teenagers' Physical Activity
A Wearable mHealth Device to Promote Teenagers' Physical Activity: A Pilot RCT
Due to disparities in childhood obesity, interventions for physical activity promotion and obesity prevention for low socioeconomic and racial/ethnic minority children and adolescents are vital to address disparities across the lifespan. Mobile health applications (mHealth apps) are a rapidly growing and promising approach for interactive and individualized interventions for disease prevention. Smart phones are a promising platform to reach racial/ethnic minority and lower income groups due to high rates of adoption of smart phone usage among these groups When paired with wearable sensing devices, mHealth apps for smart phones can collect data and provide feedback to users in real time. In a study among university students regarding mHealth apps, participants expressed interest in the "ability to record and track behaviors and goals and the ability to acquire advice and information 'on the go'". For physical activity in particular, wearable physical activity monitors designed for consumers that objectively measure and display data related to an individual's physical activity on smart phones through mHealth apps have become widely available and affordable. These wearable devices wirelessly upload data and provide users with physical activity data visualization and goal setting features that can be customized for each user via internet-based applications for smart phones, tablets, and/or computers. While several internet-based behavioral programs to promote pediatric physical activity have been reported in a recent review, none examined wearable sensing devices coupled with mHealth apps. Similarly, a 2013 review on mHealth technologies for physical activity assessment and promotion reported no studies that used wearable sensing devices for intervention delivery and called for research to evaluate feasibility.
The Primary Goal is to conduct a pilot randomized controlled trial (RCT) of the FitBit Flex, a popular wearable physical activity sensing device that allows data visualization and goal setting on smart phones. The target population will be adolescents ages 14-18 years old in the Seattle-metro area (n=40) with approximately 50% from low income households or belonging to a racial/ethnic minority. We will target this older age group since they have the lowest levels of physical activity among the pediatric population. This pilot study will provide feasibility and preliminary data for a future R01-funded RCT of the Flex mHealth device and app.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Washington
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Seattle, Washington, États-Unis, 98145-5005
- Seattle Children's Research Institute
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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:
- 14-18 years old
- lives in the Seattle-metro area
- able to complete forms in English
- no restrictions by a health care provider on physical activity or walking
- own a smart phone or similar FitBit compatible mobile device (e.g. iPod Touch)
- agree to install and share data from the FitBit Flex smart phone app with the investigators
- attends study high school or health clinic or receives and clicks on a Facebook advertisement for the study
Exclusion Criteria:
- has been restricted by a health care provider for physical activity or walking
- does not live in the Seattle-metro area
- does not attend a study school or clinic, or did not receive a Facebook advertisement for the study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune intervention: Contrôle des listes d'attente
Aucune intervention
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Expérimental: FitBit only
Participants will use the FitBit device
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Participants will use the FitBit device
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Expérimental: FitBit and Text Messages
Participants will use the FitBit device and receive daily affective text messages
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Participants will use the FitBit device and receive daily affective text messages
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Post-intervention daily steps
Délai: Measured during weeks 3-4 of the intervention
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Measured during weeks 3-4 of the intervention
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pre-intervention daily steps
Délai: Baseline
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Baseline
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Pre-intervention moderate-to-vigorous physical activity (MVPA)
Délai: Baseline
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Accelerometry
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Baseline
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Post-intervention moderate-to-vigorous physical activity
Délai: During weeks 3-4 of the intervention
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accelerometry
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During weeks 3-4 of the intervention
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jason A Mendoza, MD, MPH, University of Washington
- Chercheur principal: Megan Moreno, MD, MPH, University of Washington
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 (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- SCRI-24100018
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 .