- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03539237
Closing the Gap Between Self-reported and Accelerometer-based Physical Activity (GAP)
Effect of an Intensity Level Video Demonstration on the Gap Between Self-reported and Accelerometer-measured Physical Activity in Individuals Aged 40 to 75 Years
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study examines whether the demonstration of different intensity levels of physical activity by video in the context of a tablet PC (personal computer)-based survey can achieve a higher degree of concordance between self-reported and accelerometer-measured physical activity compared to an assessment without video demonstration. The recruitment of the study participants in the age range between 40 and 75 years takes place in a shopping center in the city Greifswald in Germany.
Informed consent consists of: (i) activity recording over 7 days using an accelerometer, (ii) completion of standardized questionnaires, (iii) participation in a standardized measurement of weight and height as well as waist and hip circumference.
Participants are asked to wear an accelerometer during the day for a period of 7 days. Subsequently, a questionnaire about the frequency, duration and intensity of physical activity in the last 7 days will be answered in the DZHK (Deutsches Zentrum für Herz-Kreislauf-Forschung)- examination center. Prior to the physical activity assessment the study participants are randomly assigned to the study conditions "Video" or "No Video" (ratio 1:1). Optionally, participants may receive feedback on their physical activity measured by accelerometer upon completion of the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Greifswald, Germany
- Institute of Social Medicine and Prevention, University Medicine Greifswald
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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Exclusion Criteria:
- cognitive impairment
- inadequate language skills
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: "Video"-group
Video group: Individuals in this group receive the intervention "Video demonstration of physical activity intensity levels".
They watch a 3-minute-video explaining and visualizing light-, moderate-, and vigorous-intensity levels of physical activity before completing a tablet PC-supported physical activity assessment at the DZHK-examination center.The video can not be skipped.
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In the video demonstration, an approximately 50 year old male explains 1) light-intensity, 2) moderate-intensity, and 3) vigorous-intensity physical activity referring to differences in heart rate, breathing frequency and capability to talk normally.
Simultaneously, on a treadmill he demonstrates the body signs of the three intensity levels.
He gives examples and points out that there are individual differences in the intensity evaluation of comparable activities.
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No Intervention: "No video"-group
No video group: Individuals in this group do not receive the intervention "Video demonstration of physical activity intensity levels".
They complete a tablet PC-supported physical activity assessment at the DZHK-examination center without receiving a 3-minute-video explaining and visualizing the different intensity levels of physical activity.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Difference between physical activity measured by self-report and by accelerometry
Time Frame: The accelerometer is worn for 7 days and then the IPAQ-SF is retrospectively answered for these 7 days.
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Measures: assessement via tablet PC (International Physical Activity Questionnaire-Short Form, IPAQ-SF) and objective measurement by accelerometry
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The accelerometer is worn for 7 days and then the IPAQ-SF is retrospectively answered for these 7 days.
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- GAP05/18
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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