NCT02794727

Brief Summary

Decreased physical activity is not only associated with multiple chronic medical conditions, including obesity, but also with depressed mood, and other negative emotions. As many employed adults spend a great deal of time at work where we are predominantly sedentary, strategies to increase physical activity at work are being pursued to help improve the physical and mental health of Americans. This 17 week randomized controlled trial will investigate changes of occupational physical activity in three groups: those provided with a FitBit® but not able to monitor their activity level, and those provided with activity goals and individual physical activity challenges, and those who do not use a FitBit®.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

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

June 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 9, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 29, 2020

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

2.4 years

First QC Date

June 2, 2016

Results QC Date

March 17, 2020

Last Update Submit

April 16, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Fitbit Step Count Per Day

    change in number of daily steps as measured by the fitbit monitor

    Baseline through Week 16

Study Arms (3)

Blinded Fitbit

SHAM COMPARATOR

Subjects will wear the physical activity monitor (fitbit) for 12 weeks but will be blinded to the monitor display.

Device: Blinded Fitbit

Unblinded Fitbit

ACTIVE COMPARATOR

Subjects will wear the physical activity monitor (fitbit) for 12 weeks. They will have access to the monitor display and will have consults with study physician to set goals for the duration of the study.

Device: Unblinded Fitbit

No Fitbit

NO INTERVENTION

Subjects will not wear any activity monitor for 12 weeks.

Interventions

Subjects will wear a blinded Fitbit to monitor activity while in the workplace for 12 weeks.

Blinded Fitbit

Subjects will be unblinded to the Fitbit display for 12 weeks with set activity goals.

Unblinded Fitbit

Eligibility Criteria

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

You may qualify if:

  • Be between 18 - 65 years of age
  • Be a Mayo Clinic employee at 0.75 FTE or more
  • Have no previous use of any activity monitor for 14 consecutive days or more
  • Not be pregnant by subject self report
  • Have a stable weight - defined as self-reported weight that has not changed more than 10% in the past 3 months
  • Not have any previous history of joint problems that limit free movement, as determined by the PI
  • Be able to participate fully in all aspects of the study
  • Have understood and signed study informed consent.

You may not qualify if:

  • Have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence or skew data collection - such as a position where they predominantly provide transport as part of their job.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Nanda S, Hurt RT, Croghan IT, Mundi MS, Gifford SL, Schroeder DR, Fischer KM, Bonnes SL. Improving Physical Activity and Body Composition in a Medical Workplace Using Brief Goal Setting. Mayo Clin Proc Innov Qual Outcomes. 2019 Oct 16;3(4):495-505. doi: 10.1016/j.mayocpiqo.2019.07.002. eCollection 2019 Dec.

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Sanjeev Nanda, MD
Organization
Mayo Clinic

Study Officials

  • Ivana T Croghan, PhD

    Mayo Cinic

    STUDY CHAIR
  • Ryan T Hurt, MD, PhD

    Mayo Clinic

    STUDY DIRECTOR
  • Sanjeev Nanda, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
  • Sara Bonnes, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 2, 2016

First Posted

June 9, 2016

Study Start

June 1, 2016

Primary Completion

November 1, 2018

Study Completion

April 1, 2019

Last Updated

April 29, 2020

Results First Posted

April 29, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations