The Impact of Real-time Feedback on Physical Activity Patterns in Flemish Employees

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Katholieke Universiteit Leuven.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Karen Van Hoye, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01432327
First received: September 9, 2011
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Sedentary Lifestyle
Device: SenseWear display
Device: Pedometer
Device: SenseWear Armband
Behavioral: Personal Coaching

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Impact of Real-time Feedback on Physical Activity Patterns in Flemish Employees: an Intervention Study

Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Physical Activity Level [ Time Frame: One year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Daily Energy Expenditure in Physical Activity [ Time Frame: One year ] [ Designated as safety issue: No ]
    Minutes of physical activity. Activities can be classified as moderate-intensity, vigorous-intensity or very vigorous-intensity activities based upon the amount of energy used by the body while doing the activity.

  • Percent of Participants Losing Fat Percentage [ Time Frame: One Year ] [ Designated as safety issue: No ]
    The amount of body fat is measured by bioelectrical impedance analysis (BIA).

  • Stages of Motivational Readiness for Physical Activity [ Time Frame: One Year ] [ Designated as safety issue: No ]
    According to The Stages of Motivational Readiness for Change Model (SOC), individuals move through a series of stages as they adopt and maintain a new habit(Prochaska & DiClemente, 1983). Specifically, the stages include Precontemplation, Contemplation, Preparation, Action, and Maintenance.The relevant variables were assessed in a self-administered questionnaire.

  • Step Count [ Time Frame: One Year ] [ Designated as safety issue: No ]
    Daily number of steps


Enrollment: 227
Study Start Date: August 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control group
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
Participants wear the SenseWear Armband for 4 weeks
Other Names:
  • SenseWear Pro3 Armband
  • BodyMedia, Inc. Pittsburgh, PA
Experimental: Step Group
This group receives feedback about the daily amount of steps by means of a pedometer.
Device: Pedometer
Participants receive a pedometer to determine their daily amount of steps. Every day they write down their amount of steps in a step diary.
Other Name: Yamax Digi-Walker SW-200
Experimental: Display Group
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

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.

Other Name: BodyMedia® Display (Model DD100)
Experimental: Coaching Group
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
A weekly meeting with a Personal Coach to evaluate the physical activity patterns in daily life

Detailed Description:

The purpose of this intervention study is to determine the effectiveness of continuous self-monitoring and real-time feedback from the SenseWear Armband (BodyMedia) alone and in combination with Personal Coaching to enhance physical activity and influence consciousness about its own physical activity patterns over a 12-month period in sedentary Flemish employees. The investigators hypothesize that the use of the feedback will increase awareness and subsequent physical activity levels of inactive office workers. Another hypothesizes is that the weekly meeting with a Personal Coach will add a controlling element and therefore employees of the 'coaching group' will have a higher physical activity level at the end of the intervention period compared to the other groups.

  Eligibility

Ages Eligible for Study:   18 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Student
  • Senior
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01432327

Locations
Belgium
Katholieke Universiteit Leuven - Tervuursevest 101
Leuven, Belgium, 3000
Sponsors and Collaborators
Katholieke Universiteit Leuven
Investigators
Study Director: Johan Lefevre, Prof Dr. Katholieke Universiteit Leuven
  More Information

No publications provided

Responsible Party: Karen Van Hoye, Phd Student, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01432327     History of Changes
Other Study ID Numbers: KULEUVEN_RTFDB
Study First Received: September 9, 2011
Results First Received: February 15, 2012
Last Updated: April 18, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by Katholieke Universiteit Leuven:
motor activity
randomized controlled trial
feedback

ClinicalTrials.gov processed this record on September 18, 2014