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

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ClinicalTrials.gov Identifier: NCT01432327
Recruitment Status : Completed
First Posted : September 12, 2011
Results First Posted : April 18, 2012
Last Update Posted : March 13, 2015
Sponsor:
Information provided by (Responsible Party):
Karen Van Hoye, KU Leuven

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sedentary Lifestyle Device: SenseWear display Device: Pedometer Device: SenseWear Armband Behavioral: Personal Coaching Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 227 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Impact of Real-time Feedback on Physical Activity Patterns in Flemish Employees: an Intervention Study
Study Start Date : August 2010
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Physical Activity Level [ Time Frame: One year ]
    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 :
  1. Daily Energy Expenditure in Physical Activity [ Time Frame: One year ]
    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.

  2. Percent of Participants Losing Fat Percentage [ Time Frame: One Year ]
    The amount of body fat is measured by bioelectrical impedance analysis (BIA).

  3. Stages of Motivational Readiness for Physical Activity [ Time Frame: One Year ]
    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.

  4. Step Count [ Time Frame: One Year ]
    Daily number of steps


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01432327


Locations
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Belgium
Katholieke Universiteit Leuven - Tervuursevest 101
Leuven, Belgium, 3000
Sponsors and Collaborators
KU Leuven
Investigators
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Study Director: Johan Lefevre, Prof Dr. KU Leuven
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Karen Van Hoye, Phd Student, KU Leuven
ClinicalTrials.gov Identifier: NCT01432327    
Other Study ID Numbers: KULEUVEN_RTFDB
First Posted: September 12, 2011    Key Record Dates
Results First Posted: April 18, 2012
Last Update Posted: March 13, 2015
Last Verified: February 2015
Keywords provided by Karen Van Hoye, KU Leuven:
motor activity
randomized controlled trial
feedback