Fitbit One and Text Messaging Prompts to Promote Physical Activity in Overweight/Obese Adults (TXT2BFIT)

October 2, 2019 updated by: University of California, San Diego

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • UCSD Moores Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SMS Text Messages & Fitbit One
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.
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.
Other Names:
  • physical activity
  • self-monitoring
  • self-regulation
  • mobile app
  • Fitbit One
  • SMS text-messaging
  • SMS text-messages
  • wearable sensor
  • wearable device
  • text message reminders
  • text message prompts
  • Actigraph GT3X+
  • website
  • tracker
  • mobile application
  • MVPA
  • fairly active minutes
  • very active minutes
Active Comparator: Fitbit One Only
An active control group was also provided the Fitbit One to facilitate self-monitoring of PA throughout the 6-week study period.
Behavioral: Fitbit One Only
Active controls received a Fitbit One to facilitate self-monitoring (and no text messages)
Other Names:
  • physical activity
  • self-monitoring
  • self-regulation
  • mobile app
  • Fitbit One
  • wearable sensor
  • wearable device
  • text message reminders
  • text message prompts
  • Actigraph GT3X+
  • website
  • tracker
  • mobile application
  • MVPA
  • fairly active minutes
  • very active minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minutes per week of physical activity by intensity level (Actigraph GT3X+)
Time Frame: up to 6 weeks
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity levels (Fitbit One)
Time Frame: up to 6 weeks
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
Steps per a day (Fitbit One)
Time Frame: up to 6 weeks
Steps per day were assessed using the Fitbit One throughout the entire duration of the study
up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

Carol Vassiliadis Family

Investigators

  • Principal Investigator: Julie Wang, PhD, MPH, University of California, San Francisco
  • Study Chair: John Pierce, PhD, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

July 10, 2014

First Submitted That Met QC Criteria

July 11, 2014

First Posted (Estimate)

July 14, 2014

Study Record Updates

Last Update Posted (Actual)

October 4, 2019

Last Update Submitted That Met QC Criteria

October 2, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 130024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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