Physical ActivityGAPNCT03539237
Closing the Gap Between Self-reported and Accelerometer-based Physical Activity
A study testing Video demonstration of physical activity intensity levels in people with Physical Activity, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
This study examines the effect of a video-based intensity level demonstration on self-reported physical activity in individuals aged between 40 and 75 years. Aim of the video demonstration is to achieve a better concordance of physical activity reports with accelerometer-based measurements. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Video demonstration of physical activity intensity levels
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 379 participants
- Where
- 1 siteGermany
- Study dates
- 23 May 2018to 28 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
Who cannot join
- cognitive impairment
- inadequate language skills
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Social Medicine and Prevention, University Medicine Greifswald
Greifswald
About this study
Official title: 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
This study examines the effect of a video-based intensity level demonstration on self-reported physical activity in individuals aged between 40 and 75 years. Aim of the video demonstration is to achieve a better concordance of physical activity reports with accelerometer-based measurements.
Read the 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.
- Conditions
- Physical Activity
- Being tested
- Video demonstration of physical activity intensity levels
- Keywords
- Video demonstration, Intensity levels, Physical activity, Self-report, Accelerometer
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video demonstration of physical activity intensity levelsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| "Video"-group | Experimental | 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. Receives: Other: Video demonstration of physical activity intensity levels |
| "No video"-group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between physical activity measured by self-report and by accelerometry
Measures: assessement via tablet PC (International Physical Activity Questionnaire-Short Form, IPAQ-SF) and objective measurement by accelerometry
Measured: The accelerometer is worn for 7 days and then the IPAQ-SF is retrospectively answered for these 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start23 May 2018
- Primary completion28 Nov 2018
- Study completion28 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539237
- Sponsor's protocol ID
- GAP05/18
- Acronym
- GAP
- Status last verified
- Jan 2019
- First submitted
- 15 May 2018
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Voigt L, Ullrich A, Gross S, Guertler D, Jaeschke L, Dorr M, van den Berg N, John U, Ulbricht S. Associations of accelerometer-based sedentary bouts with adiposity markers among German adults - results from a cross-sectional study. BMC Public Health. 2023 Mar 10;23(1):469. doi: 10.1186/s12889-023-15304-8.
PubMed 36899317
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03539237
- Acronym / sponsor ID
- GAP / GAP05/18
- Conditions
- Physical Activity
- Keywords
- Video demonstration, Intensity levels, Physical activity, Self-report, Accelerometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Collaborators
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Study start
- 23 May 2018 (actual)
- Primary completion
- 28 Nov 2018 (actual)
- Study completion
- 28 Nov 2018 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the effect of a video-based intensity level demonstration on self-reported physical activity in individuals aged between 40 and 75 years. Aim of the video demonstration is to achieve a better concordance of physical activity reports with accelerometer-based measurements.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Video"-group | Experimental | Other: Video demonstration of physical activity intensity levelsVideo 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. |
| "No video"-group | No intervention | –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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (2 listed)
- cognitive impairment
- inadequate language skills
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video demonstration of physical activity intensity levelsIn 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. | Other | "Video"-group |
Primary outcome
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.
Measures: assessement via tablet PC (International Physical Activity Questionnaire-Short Form, IPAQ-SF) and objective measurement by accelerometry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
- Derived from this study: PubMed 36899317Voigt L, Ullrich A, Gross S, Guertler D, Jaeschke L, Dorr M, van den Berg N, John U, Ulbricht S. Associations of accelerometer-based sedentary bouts with adiposity markers among German adults - results from a cross-sectional study. BMC Public Health. 2023 Mar 10;23(1):469. doi: 10.1186/s12889-023-15304-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video demonstration of physical activity intensity levels in people with Physical Activity, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03539237, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2019.