NCT02188875

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2014

Completed
Last Updated

October 4, 2019

Status Verified

October 1, 2019

Enrollment Period

1 year

First QC Date

July 10, 2014

Last Update Submit

October 2, 2019

Conditions

Keywords

Fitbit Onewearable sensorwearable deviceweb-based interventionSMS text messagesrandomized controlled trialphysical activitybehavioral interventiontext message promptstext messagingtechnologyexercise

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Minutes per week of physical activity by intensity level (Actigraph GT3X+)

    up to 6 weeks

Other Outcomes (2)

  • Physical activity levels (Fitbit One)

    up to 6 weeks

  • Steps per a day (Fitbit One)

    up to 6 weeks

Study Arms (2)

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.

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.

Behavioral: Fitbit One Only

Interventions

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.

Also known as: 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
SMS Text Messages & Fitbit One
Fitbit One OnlyBEHAVIORAL

Active controls received a Fitbit One to facilitate self-monitoring (and no text messages)

Also known as: 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
Fitbit One Only

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD Moores Cancer Center

La Jolla, California, 92093, United States

Location

Related Links

MeSH Terms

Conditions

Health BehaviorObesityMotor Activity

Interventions

Wearable Electronic DevicesBlood Glucose Self-MonitoringProfessional AutonomyExercise

Condition Hierarchy (Ancestors)

BehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrical Equipment and SuppliesEquipment and SuppliesBlood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicSelf-TestingSelf CareTherapeuticsInvestigative TechniquesProfessional PracticeOrganization and AdministrationHealth Services AdministrationMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Julie Wang, PhD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR
  • John Pierce, PhD

    University of California, San Diego

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2014

First Posted

July 14, 2014

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

October 4, 2019

Record last verified: 2019-10

Locations