Physical ActivityNCT02469727
mHealth Intervention to Promote Cancer Survivors' Physical Activity
A study testing Fitbit and Facebook group in people with Physical Activity and Quality of Life, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
The Primary Goal is to conduct a 5-10 week randomized controlled trial (RCT) of the Fitbit Flex, a popular, affordable, wearable physical activity tracking device, and the Fitbit mHealth app. The target population will be childhood cancer survivors 14-18 years old recruited from Seattle Children's Hospital. 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, Quality of Life
- What is being tested?
- Fitbit and Facebook group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jul 2016
- 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
- in remission for childhood cancer and previously treated for childhood cancer at Seattle Children's Hospital
- ≥1-year post-cancer therapy
- ambulatory without any known medical contraindications to participation
- able to complete surveys in English
- agree to install and share data from the FitBit smart phone app with the investigators
Who cannot join
- currently or previously used a wearable physical activity sensing device to improve physical activity
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Research Institute
Seattle, Washington, 98145-5005
About this study
The Primary Goal is to conduct a 5-10 week randomized controlled trial (RCT) of the Fitbit Flex, a popular, affordable, wearable physical activity tracking device, and the Fitbit mHealth app. The target population will be childhood cancer survivors 14-18 years old recruited from Seattle Children's Hospital. For the intervention group, peer influences will be engaged via a private, social network (e.g. a Facebook group) customized for survivors. Measurements will be completed (1) at baseline, prior to randomization, and (2) during the final week of the intervention period (follow-up measure). This study will provide initial proof of concept and allow for further customization of the intervention for childhood cancer survivors in anticipation of a future, larger proposal to study physical activity and related outcomes over a multi-year period.
- Conditions
- Physical Activity, Quality of Life
- Being tested
- Fitbit, Facebook group
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitbitBehavioural
Participants will use the FitBit device to track their physical activity
Facebook groupBehavioural
Participants will receive and post messages and receive badges on the Facebook group
| Study group | Role | What they receive |
|---|---|---|
| Fitbit + Facebook | Experimental | Participants will use the Fitbit device and join the Facebook group. Receives: Behavioral: Fitbit; Behavioral: Facebook group |
| Usual care control | No intervention | No intervention provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-intervention physical activity (measured by accelerometers)
Measured: up to week 10
Secondary outcomes (1)
Post-intervention health related quality of life (measured by questionnaire)
Measured: up to week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Mendoza, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469727
- Sponsor's protocol ID
- 15563
- Status last verified
- Oct 2016
- First submitted
- 8 Jun 2015
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth Intervention to Promote Cancer Survivors' Physical Activity
- ClinicalTrials.gov ID
- NCT02469727
- Acronym / sponsor ID
- 15563
- Conditions
- Physical Activity, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 11 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Primary Goal is to conduct a 5-10 week randomized controlled trial (RCT) of the Fitbit Flex, a popular, affordable, wearable physical activity tracking device, and the Fitbit mHealth app. The target population will be childhood cancer survivors 14-18 years old recruited from Seattle Children's Hospital. For the intervention group, peer influences will be engaged via a private, social network (e.g. a Facebook group) customized for survivors. Measurements will be completed (1) at baseline, prior to randomization, and (2) during the final week of the intervention period (follow-up measure). This study will provide initial proof of concept and allow for further customization of the intervention for childhood cancer survivors in anticipation of a future, larger proposal to study physical activity and related outcomes over a multi-year period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fitbit + Facebook | Experimental | Behavioral: Fitbit, Behavioral: Facebook groupParticipants will use the Fitbit device and join the Facebook group. |
| Usual care control | No intervention | –No intervention provided. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- in remission for childhood cancer and previously treated for childhood cancer at Seattle Children's Hospital
- ≥1-year post-cancer therapy
- ambulatory without any known medical contraindications to participation
- able to complete surveys in English
- agree to install and share data from the FitBit smart phone app with the investigators
Key exclusion criteria (1 listed)
- currently or previously used a wearable physical activity sensing device to improve physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FitbitParticipants will use the FitBit device to track their physical activity | Behavioural | Fitbit + Facebook |
| Facebook groupParticipants will receive and post messages and receive badges on the Facebook group | Behavioural | Fitbit + Facebook |
Primary outcome
Post-intervention physical activity (measured by accelerometers)
Time frame: up to week 10
1 secondary outcome
Post-intervention health related quality of life (measured by questionnaire)
Time frame: up to week 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit and Facebook group in people with Physical Activity and Quality of Life, 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 5 inclusion and 1 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 Oct 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 physical activity (measured by accelerometers) (time frame: up to week 10). 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 Oct 2016.