Fitbit One and Text Messaging Prompts to Promote Physical Activity in Overweight/Obese Adults

Obesity Clinical Trial

— TXT2BFIT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02188875
• Other study ID #: 130024
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: January 2014

Study information

• Verified date: October 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

• 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

Related Conditions & MeSH terms

• Health Behavior
• Obesity
• Overweight

Intervention

Behavioral:
• SMS Text Messages & Fitbit One
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 Only
Active controls received a Fitbit One to facilitate self-monitoring (and no text messages)

Locations

Country	Name	City	State
United States	UCSD Moores Cancer Center	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	Carol Vassiliadis Family

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical activity levels (Fitbit One)	Physical activity by intensity level (i.e., fairly and very active minutes and total active minutes) were assessed using the Fitbit One throughout the entire duration of the study	up to 6 weeks
Other	Steps per a day (Fitbit One)	Steps per day were assessed using the Fitbit One throughout the entire duration of the study	up to 6 weeks
Primary	steps per day (Actigraph GT3X+)	Number of steps per day was measured using Actigraph GT3X+ at baseline and 6-week follow-up	up to 6 weeks
Secondary	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	up to 6 weeks

External Links

•   published manuscript of primary study results