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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01432327
Other study ID # KULEUVEN_RTFDB
Secondary ID
Status Completed
Phase N/A
First received September 9, 2011
Last updated February 23, 2015
Start date August 2010
Est. completion date February 2015

Study information

Verified date February 2015
Source Katholieke Universiteit Leuven
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 227
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 68 Years
Eligibility Inclusion Criteria:

- Employee

- Physical Activity Level < 1.71 MET

- Willing to wear the SenseWear Armband for 5-6 weeks

Exclusion Criteria:

- Student

- Senior

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

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.
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.
SenseWear Armband
Participants wear the SenseWear Armband for 4 weeks
Behavioral:
Personal Coaching
A weekly meeting with a Personal Coach to evaluate the physical activity patterns in daily life

Locations

Country Name City State
Belgium Katholieke Universiteit Leuven - Tervuursevest 101 Leuven

Sponsors (1)

Lead Sponsor Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Daily Energy Expenditure in Physical Activity 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. One year No
Secondary Percent of Participants Losing Fat Percentage The amount of body fat is measured by bioelectrical impedance analysis (BIA). One Year No
Secondary Stages of Motivational Readiness for Physical Activity 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. One Year No
Secondary Step Count Daily number of steps One Year No
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