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

Primary Purpose

Health Behavior, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SMS Text Messages & Fitbit One
Fitbit One Only
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Health Behavior focused on measuring 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

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UCSD Moores Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SMS Text Messages & Fitbit One

Fitbit One Only

Arm Description

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.

An active control group was also provided the Fitbit One to facilitate self-monitoring of PA throughout the 6-week study period.

Outcomes

Primary Outcome Measures

steps per day (Actigraph GT3X+)
Number of steps per day was measured using Actigraph GT3X+ at baseline and 6-week follow-up

Secondary Outcome Measures

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

Full Information

First Posted
July 10, 2014
Last Updated
October 2, 2019
Sponsor
University of California, San Diego
Collaborators
Carol Vassiliadis Family
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1. Study Identification

Unique Protocol Identification Number
NCT02188875
Brief Title
Fitbit One and Text Messaging Prompts to Promote Physical Activity in Overweight/Obese Adults
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Diego
Collaborators
Carol Vassiliadis Family

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Behavior, Obesity
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SMS Text Messages & Fitbit One
Arm Type
Experimental
Arm Description
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.
Arm Title
Fitbit One Only
Arm Type
Active Comparator
Arm Description
An active control group was also provided the Fitbit One to facilitate self-monitoring of PA throughout the 6-week study period.
Intervention Type
Behavioral
Intervention Name(s)
SMS Text Messages & Fitbit One
Other Intervention Name(s)
Fitbit One, SMS text-messaging, SMS text-messages, wearable sensor, wearable device, text message reminders, text message prompts, Actigraph GT3X+, self-monitoring, self-regulation, physical activity, website, tracker, mobile application, mobile app, MVPA, fairly active minutes, very active minutes
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Fitbit One Only
Other Intervention Name(s)
Fitbit One, wearable sensor, wearable device, text message reminders, text message prompts, Actigraph GT3X+, self-monitoring, self-regulation, physical activity, website, tracker, mobile application, mobile app, MVPA, fairly active minutes, very active minutes
Intervention Description
Active controls received a Fitbit One to facilitate self-monitoring (and no text messages)
Primary Outcome Measure Information:
Title
steps per day (Actigraph GT3X+)
Description
Number of steps per day was measured using Actigraph GT3X+ at baseline and 6-week follow-up
Time Frame
up to 6 weeks
Secondary Outcome Measure Information:
Title
Minutes per week of physical activity by intensity level (Actigraph GT3X+)
Description
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
Time Frame
up to 6 weeks
Other Pre-specified Outcome Measures:
Title
Physical activity levels (Fitbit One)
Description
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
Time Frame
up to 6 weeks
Title
Steps per a day (Fitbit One)
Description
Steps per day were assessed using the Fitbit One throughout the entire duration of the study
Time Frame
up to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Wang, PhD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Pierce, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Study Chair
Facility Information:
Facility Name
UCSD Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

Links:
URL
http://online.liebertpub.com/doi/abs/10.1089/tmj.2014.0176
Description
published manuscript of primary study results

Learn more about this trial

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

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