NCT01432327

Brief Summary

The aim of the study is to assess an increase of daily physical activity from electronic self-monitoring, to compare these values to the 10.000 step program, and to compare with real-time feedback with and without guidance from a Personal Coach.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
227

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 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

August 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2011

Completed
7 months until next milestone

Results Posted

Study results publicly available

April 18, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 13, 2015

Status Verified

February 1, 2015

Enrollment Period

4.5 years

First QC Date

September 9, 2011

Results QC Date

February 15, 2012

Last Update Submit

February 23, 2015

Conditions

Keywords

motor activityrandomized controlled trialfeedback

Outcome Measures

Primary Outcomes (1)

  • Physical Activity Level

    To account for differences in body size and composition, the 24-hour energy requirement (kcal/day) is expressed as a multiple of the basal metabolic rate per 24 hours by using the PAL value (PAL = total energy expenditure/basal metabolic rate). A desirable PAL includes the regular practice of physical activity at work or in spare time with an intensity and duration that will reduce the risk of becoming overweight and developing a variety of non-communicable chronic diseases usually associated as co-morbidities with obesity. This corresponds to PAL values of 1.75 and higher.

    One year

Secondary Outcomes (4)

  • Daily Energy Expenditure in Physical Activity

    One year

  • Percent of Participants Losing Fat Percentage

    One Year

  • Stages of Motivational Readiness for Physical Activity

    One Year

  • Step Count

    One Year

Study Arms (4)

Control group

PLACEBO COMPARATOR

This group receives no kind of feedback during the intervention period. The participants wear the SenseWear Armband for 4 weeks and results of the intervention are discussed after the 4 week intervention period.

Device: SenseWear Armband

Step Group

EXPERIMENTAL

This group receives feedback about the daily amount of steps by means of a pedometer.

Device: Pedometer

Display Group

EXPERIMENTAL

Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display

Device: SenseWear display

Coaching Group

EXPERIMENTAL

Participants receive real-time feedback on their energy expenditure, step count and minutes of physical activity by means of the SenseWear Display and weekly meet with a Personal Coach to discuss their progress

Behavioral: Personal Coaching

Interventions

Participants use the self-monitoring device (display) to aid behavior change via real-time lifestyle feedback targeting physical activity. The display has a versatile design that allows it to be clipped to a shirt, bag or belt loop. The Display can help participants stay in sync with their daily goals.

Also known as: BodyMedia® Display (Model DD100)
Display Group
PedometerDEVICE

Participants receive a pedometer to determine their daily amount of steps. Every day they write down their amount of steps in a step diary.

Also known as: Yamax Digi-Walker SW-200
Step Group

Participants wear the SenseWear Armband for 4 weeks

Also known as: SenseWear Pro3 Armband, BodyMedia, Inc. Pittsburgh, PA
Control group

A weekly meeting with a Personal Coach to evaluate the physical activity patterns in daily life

Coaching Group

Eligibility Criteria

Age18 Years - 68 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Employee
  • Physical Activity Level \< 1.71 MET
  • Willing to wear the SenseWear Armband for 5-6 weeks

You may not qualify if:

  • Student
  • Senior

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Katholieke Universiteit Leuven - Tervuursevest 101

Leuven, 3000, Belgium

Location

Related Publications (1)

  • Van Hoye K, Wijtzes AI, Lefevre J, De Baere S, Boen F. Year-round effects of a four-week randomized controlled trial using different types of feedback on employees' physical activity. BMC Public Health. 2018 Apr 12;18(1):492. doi: 10.1186/s12889-018-5402-0.

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

Malfunction of the SenseWear Armband: 4 out of the 320 baseline measurements

Results Point of Contact

Title
Karen Van Hoye
Organization
Katholieke Universiteit Leuven

Study Officials

  • Johan Lefevre, Prof Dr.

    KU Leuven

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd Student

Study Record Dates

First Submitted

September 9, 2011

First Posted

September 12, 2011

Study Start

August 1, 2010

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 13, 2015

Results First Posted

April 18, 2012

Record last verified: 2015-02

Locations