NCT03837366

Brief Summary

Wearable fitness monitors are increasingly popular but the actual utility of these devices for promoting physical activity behavior is unknown. The purpose is to examine the efficacy of the Fitbit monitor for previously inactive individuals when used alone or following brief training in behavior change strategies and techniques. Psychosocial factors will be assessed and changes in physical activity will be monitored over three months to determine the efficacy of this intervention and to better understand individual differences in effectiveness.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

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

June 11, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2016

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

9 months

First QC Date

February 7, 2019

Last Update Submit

February 11, 2019

Conditions

Keywords

Activity trackerPhysical ActivitymHealthhabitMotivational Interviewing

Outcome Measures

Primary Outcomes (2)

  • Steps

    Average steps accumulated per day assessed via the activPAL

    3 months

  • Moderate and Vigorous Physical Activity

    Average minutes per day assessed via a combination of activPAL and ActiGraph

    3 months

Secondary Outcomes (1)

  • Habit Development

    3 months

Study Arms (2)

Activity Tracker with Health Coaching

EXPERIMENTAL

Participants assigned to this condition will receive a Fitbit activity tracker to use for 3 months. Also, they will be asked to come in for a visit approximately one week following baseline assessments. Using the principles of Motivational Interviewing and Habit Formation, participants will discuss their perceived benefits and barriers of becoming more physically active with a member of the research team. They will also be encouraged to set a goal related to using their Fitbit to increase their physical activity. Lastly, they will be given information regarding habit formation and encouraged to identify one or more cues that regularly occur in their daily life to check their Fitbit data as a prompt to engage in physical activity.

Behavioral: Activity tracker and health coaching

Activity Tracker alone

ACTIVE COMPARATOR

Participants assigned to this condition will use their Fitbit on their own for the duration of 3- month intervention, similar to the experience of participants buying the device off-the-shelf.

Behavioral: Activity tracker and health coaching

Interventions

Use of an activity tracker alone or in combination with health coaching on physical activity behaviors.

Also known as: Fitbit
Activity Tracker aloneActivity Tracker with Health Coaching

Eligibility Criteria

Age24 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Not meeting physical activity guidelines

You may not qualify if:

  • Meeting physical activity guidelines
  • Injury or condition that limits mobility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ellingson LD, Lansing JE, DeShaw KJ, Peyer KL, Bai Y, Perez M, Phillips LA, Welk GJ. Evaluating Motivational Interviewing and Habit Formation to Enhance the Effect of Activity Trackers on Healthy Adults' Activity Levels: Randomized Intervention. JMIR Mhealth Uhealth. 2019 Feb 14;7(2):e10988. doi: 10.2196/10988.

MeSH Terms

Conditions

Motor ActivityHabits

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and SuppliesWearable Electronic DevicesElectrical Equipment and Supplies

Study Officials

  • Laura D Ellingson-Sayen, PhD

    Iowa State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Individuals processing outcome data are blinded to experimental condition.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants are randomized to one of two groups. One group received an activity tracker and the other received an activity tracker in combination with Health Coaching.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 7, 2019

First Posted

February 12, 2019

Study Start

June 11, 2015

Primary Completion

March 3, 2016

Study Completion

March 3, 2016

Last Updated

February 15, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share