Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

A Wearable mHealth Device to Promote Teenagers' Physical Activity

12. april 2016 opdateret af: Jason Mendoza, Seattle Children's Hospital

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.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • Washington
      • Seattle, Washington, Forenede Stater, 98145-5005
        • Seattle Children's Research Institute

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

14 år til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Kontrol af venteliste
Ingen indgriben
Eksperimentel: FitBit only
Participants will use the FitBit device
Participants will use the FitBit device
Eksperimentel: FitBit and Text Messages
Participants will use the FitBit device and receive daily affective text messages
Participants will use the FitBit device and receive daily affective text messages

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Post-intervention daily steps
Tidsramme: Measured during weeks 3-4 of the intervention
Measured during weeks 3-4 of the intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pre-intervention daily steps
Tidsramme: Baseline
Baseline
Pre-intervention moderate-to-vigorous physical activity (MVPA)
Tidsramme: Baseline
Accelerometry
Baseline
Post-intervention moderate-to-vigorous physical activity
Tidsramme: During weeks 3-4 of the intervention
accelerometry
During weeks 3-4 of the intervention

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Jason A Mendoza, MD, MPH, University of Washington
  • Ledende efterforsker: Megan Moreno, MD, MPH, University of Washington

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. marts 2014

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. december 2015

Datoer for studieregistrering

Først indsendt

7. januar 2014

Først indsendt, der opfyldte QC-kriterier

7. januar 2014

Først opslået (Skøn)

9. januar 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. april 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. april 2016

Sidst verificeret

1. april 2016

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • SCRI-24100018

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 Fysisk aktivitet

Kliniske forsøg med FitBit only

Abonner