Health BehaviorTXT2BFITNCT02188875
Fitbit One and Text Messaging Prompts to Promote Physical Activity in Overweight/Obese Adults
A study testing SMS Text Messages & Fitbit One and Fitbit One Only in people with Health Behavior and Obesity, run by University of California, San Diego at 1 site in United States.
Trial summary
Previous studies suggest self-regulatory techniques including self-monitoring, and SMS text-messaging as an intervention modality, can modify health behaviors including physical activity (PA). Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Obesity
- What is being tested?
- SMS Text Messages & Fitbit One and Fitbit One Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jan 2014
- 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 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-69 years of age
- overweight or obese (otherwise healthy)
- does not meet recommended levels of PA (>150 min/wk of MVPA)
- owns a personal mobile phone and able to use SMS text-messaging
- owns a personal computer, has access to Internet, able to operate the Fitbit One
- fluent in English
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Moores Cancer Center
La Jolla, California, 92093
About this study
Official title: Wearable Sensor/Device With Website (Fitbit One) and SMS Text Messaging Prompts to Increase Physical Activity in Overweight/Obese Adults: A Randomized Controlled Pilot Trial
Previous studies suggest self-regulatory techniques including self-monitoring, and SMS text-messaging as an intervention modality, can modify health behaviors including physical activity (PA). The primary purpose of this study was to examine change in objectively measured PA in a randomized controlled pilot trial that tested a wearable sensor/device (Fitbit One) for self-monitoring and SMS text-messaging prompts to promote PA in overweight/obese adults. In a 2-group design, 67 participants were provided the Fitbit One and half were randomized to receive 3 daily SMS-based PA prompts. A Fitbit One was provided to facilitate self-monitoring with a wearable tracker for instant feedback and website of daily PA summaries. Outcome measures were number of steps and minutes of PA by intensity-level using two accelerometers: Actigraph GT3X+ (primary) at baseline and 6-week follow-up and Fitbit One (secondary) at baseline and weeks 1-6. The main hypothesis was that text messaging plus the Fitbit One would show a greater increase in steps and minutes of PA compared to only the Fitbit One at 6-week follow-up.
- Conditions
- Health Behavior, Obesity
- Being tested
- SMS Text Messages & Fitbit One, Fitbit One Only
- Keywords
- Fitbit One, wearable sensor, wearable device, web-based intervention, SMS text messages, randomized controlled trial, physical activity, behavioral intervention, text message prompts, text messaging, technology, exercise
- Medical subject headings
- Health Behavior, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS Text Messages & Fitbit OneBehavioural
Also called Fitbit One, SMS text-messaging, SMS text-messages, wearable sensor
The primary aim was to test text-messaging in its basic form to prompt physical activity. A secondary aim was to examine the effects of the Fitbit One.
Fitbit One OnlyBehavioural
Also called Fitbit One, wearable sensor, wearable device, text message reminders
Active controls received a Fitbit One to facilitate self-monitoring (and no text messages)
| Study group | Role | What they receive |
|---|---|---|
| SMS Text Messages & Fitbit One | Experimental | All study participants were provided a Fitbit One to facilitate self-monitoring of PA. Those who were randomly assigned to the intervention group were asked to indicate 3 preferred times of the day to receive text message prompts to do PA throughout the 6-week study period. Receives: Behavioral: SMS Text Messages & Fitbit One |
| Fitbit One Only | Active comparator | An active control group was also provided the Fitbit One to facilitate self-monitoring of PA throughout the 6-week study period. Receives: Behavioral: Fitbit One Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
steps per day (Actigraph GT3X+)
Number of steps per day was measured using Actigraph GT3X+ at baseline and 6-week follow-up
Measured: up to 6 weeks
Secondary outcomes (1)
Minutes per week of physical activity by intensity level (Actigraph GT3X+)
Moderate-to-vigorous intensity physical activity (MVPA) (min/wk) and total PA (min/wk) were assessed using Actigraph GT3X+ at baseline week and 6-week follow-up
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Carol Vassiliadis Family
- Responsible party
- Sponsor
- Investigators
- Julie Wang, PhD, MPH, Principal investigator, University of California, San FranciscoJohn Pierce, PhD, Study chair, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188875
- Sponsor's protocol ID
- 130024
- Acronym
- TXT2BFIT
- Status last verified
- Oct 2019
- First submitted
- 10 Jul 2014
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Sensor/Device With Website (Fitbit One) and SMS Text Messaging Prompts to Increase Physical Activity in Overweight/Obese Adults: A Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT02188875
- Acronym / sponsor ID
- TXT2BFIT / 130024
- Conditions
- Health Behavior, Obesity
- Keywords
- Fitbit One, wearable sensor, wearable device, web-based intervention, SMS text messages, randomized controlled trial, physical activity, behavioral intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Carol Vassiliadis Family
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 14 Jul 2014 (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.
Previous studies suggest self-regulatory techniques including self-monitoring, and SMS text-messaging as an intervention modality, can modify health behaviors including physical activity (PA). The primary purpose of this study was to examine change in objectively measured PA in a randomized controlled pilot trial that tested a wearable sensor/device (Fitbit One) for self-monitoring and SMS text-messaging prompts to promote PA in overweight/obese adults. In a 2-group design, 67 participants were provided the Fitbit One and half were randomized to receive 3 daily SMS-based PA prompts. A Fitbit One was provided to facilitate self-monitoring with a wearable tracker for instant feedback and website of daily PA summaries. Outcome measures were number of steps and minutes of PA by intensity-level using two accelerometers: Actigraph GT3X+ (primary) at baseline and 6-week follow-up and Fitbit One (secondary) at baseline and weeks 1-6. The main hypothesis was that text messaging plus the Fitbit One would show a greater increase in steps and minutes of PA compared to only the Fitbit One at 6-week follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMS Text Messages & Fitbit One | Experimental | Behavioral: SMS Text Messages & Fitbit OneAll study participants were provided a Fitbit One to facilitate self-monitoring of PA. Those who were randomly assigned to the intervention group were asked to indicate 3 preferred times of the day to receive text message prompts to do PA throughout the 6-week study period. |
| Fitbit One Only | Active comparator | Behavioral: Fitbit One OnlyAn active control group was also provided the Fitbit One to facilitate self-monitoring of PA throughout the 6-week study period. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-69 years of age
- overweight or obese (otherwise healthy)
- does not meet recommended levels of PA (>150 min/wk of MVPA)
- owns a personal mobile phone and able to use SMS text-messaging
- owns a personal computer, has access to Internet, able to operate the Fitbit One
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| SMS Text Messages & Fitbit OneAlso: Fitbit One, SMS text-messaging, SMS text-messages, wearable sensorThe primary aim was to test text-messaging in its basic form to prompt physical activity. A secondary aim was to examine the effects of the Fitbit One. | Behavioural | SMS Text Messages & Fitbit One |
| Fitbit One OnlyAlso: Fitbit One, wearable sensor, wearable device, text message remindersActive controls received a Fitbit One to facilitate self-monitoring (and no text messages) | Behavioural | Fitbit One Only |
Primary outcome
steps per day (Actigraph GT3X+)
Time frame: up to 6 weeks
Number of steps per day was measured using Actigraph GT3X+ at baseline and 6-week follow-up
1 secondary outcome
Minutes per week of physical activity by intensity level (Actigraph GT3X+)
Time frame: up to 6 weeks
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 4 Oct 2019.
- published manuscript of primary study resultsLink provided by the sponsor.
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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.
Julie Wang, PhD, MPH principal investigator
University of California, San Francisco
John Pierce, PhD study chair
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS Text Messages & Fitbit One and Fitbit One Only in people with Health Behavior and Obesity, run by University of California, San Diego 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 6 inclusion and 0 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 4 Oct 2019. 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?
steps per day (Actigraph GT3X+) (time frame: up to 6 weeks). 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 4 Oct 2019.