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Physical ActivityNCT02031185

A Wearable mHealth Device to Promote Teenagers' Physical Activity

A study testing FitBit only and FitBit and Text Messages in people with Physical Activity, run by Seattle Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 14 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Physical Activity
What is being tested?
FitBit only and FitBit and Text Messages
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
Mar 2014to Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Seattle Children's Research Institute

    Seattle, Washington, 98145-5005

Other trials in United States

About this study

Official title: 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.

Being tested
FitBit only, FitBit and Text Messages
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FitBit onlyBehavioural

    Participants will use the FitBit device

  • FitBit and Text MessagesBehavioural

    Participants will use the FitBit device and receive daily affective text messages

Study groups in NCT02031185
Study groupRoleWhat they receive
Wait-list controlNo interventionNo intervention
FitBit onlyExperimentalParticipants will use the FitBit device
Receives: Behavioral: FitBit only
FitBit and Text MessagesExperimentalParticipants will use the FitBit device and receive daily affective text messages
Receives: Behavioral: FitBit and Text Messages

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post-intervention daily steps

    Measured: Measured during weeks 3-4 of the intervention

Secondary outcomes (3)
  1. Pre-intervention daily steps

    Measured: Baseline

  2. Pre-intervention moderate-to-vigorous physical activity (MVPA)

    Accelerometry

    Measured: Baseline

  3. Post-intervention moderate-to-vigorous physical activity

    accelerometry

    Measured: During weeks 3-4 of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02031185
Sponsor's protocol ID
SCRI-24100018
Status last verified
Apr 2016
First submitted
7 Jan 2014
Last updated
13 Apr 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing FitBit only and FitBit and Text Messages in people with Physical Activity, run by Seattle Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-intervention daily steps (time frame: Measured during weeks 3-4 of the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2016.

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