Physical InactivityNCT06321926
Evaluation of the "ActiveWaiting App" Encouraging Active Exercise-related Use of Waiting Time
A study testing ActiveWaiting App in people with Physical Inactivity, run by Ludwig Boltzmann Institute for Digital Health and Prevention at 1 site in Austria.
Trial summary
The goal of this study (waitlist control study) is to evaluate the effectiveness of the ActiveWaiting App on increasing physical activity and improving quality of life in physically inactive adults in Austria. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- ActiveWaiting App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteAustria
- Study dates
- 1 Apr 2024to 24 Jun 2024
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- a sedentary lifestyle (expressed in a full to part-time sedentary job)
- using a smart phone seven days a week
- ability to operate an app on the smart phone
- age between 18 and 65 years
Who cannot join
- prior usage of the ActiveWaiting App
- achieving the World Health Organization (WHO) recommendations for physical activity (assessed via Rapid Assessment of physical Activity RAPA)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the "ActiveWaiting App" Encouraging Active Exercise-related Use of Waiting Time. A Waitlist Control Study
The goal of this study (waitlist control study) is to evaluate the effectiveness of the ActiveWaiting App on increasing physical activity and improving quality of life in physically inactive adults in Austria.
The main questions it aims to answer are:
Read more
- Does the provision of the ActiveWaiting App lead to increased physical activity behaviour, compared to a no-intervention control group?
- Does the provision of the ActiveWaiting App lead to increased health-related quality of life, compared to a no-intervention control group? Participants will use the ActiveWaiting App over a period of seven days. During this period, they will answer daily questionnaires (3 - 6 questions) in order to gather their actual physical activity behaviour. Before and after the intervention period additional questionnaires on health-related quality of life will be sent to the participants.
Participants in the waitlist control group will have a control period (seven days) before using the app.
Researchers will compare the intervention group with the waitlist control group to see if the ActiveWating App has an effect
- on physical activity behaviour and
- on quality of life.
Read the detailed description
A randomized waitlist control design will be chosen to answer the research question. Participants will be randomly assigned to the intervention group or to the waitlist control group. Block randomization with permutated block sizes will ensure that both study arms are recruited evenly over time. Allocation to the groups will be concealed. The waitlist control group will have the opportunity to use the ActiveWaiting App after the control period. Intervention and control period will be 1 week. Demographic data will be collected before randomization.
Additionally to the primary research questions, the following research questions will be addressed for explorative purposes:
- How much is the ActiveWaiting App used for active waiting and breaking time?
- Which category of exercises are used for this purpose?
- Conditions
- Physical Inactivity
- Being tested
- ActiveWaiting App
- Keywords
- sedentary behaviour, behaviour change, digital health
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiveWaiting AppDevice
The final prototype aims at increasing physical activity during the day by providing exercises for waiting periods and other idle time periods. The user can choose from a pool of exercises from five different categories (11 exercises for endurance, 65 exercises for strength, 67 exercises for flexibility, 11 exercises for relaxation, or 5 exercises for balance). Additionally, within each category, the user can choose only "discrete" exercises which are not noticeable to an observer. If the user has used the app before, the last or previously saved settings can be chosen. Every input field has an information icon showing a short description of the input field.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants in the intervention group use the ActiveWaiting App for one week. Receives: Device: ActiveWaiting App |
| Waitlist control group | Other | Participants in the waitlist control group go through a one-week control period without any intervention first, before they are using the app for one week. Receives: Device: ActiveWaiting App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of physical activity in minutes per day
Participants are asked to report their physical activity twice a day (noon and evening).
Measured: up to 2 weeks
EQ VAS / EQ-5D-5L
The EQ VAS (EuroQol Visual Analog Scale) is the last item in the EQ-5D-5L (EuroQol - 5 Dimension - 5 Level) Questionnaire. It records the respondent's overall current health on a visual analogue scale. The endpoints are labelled as 'The best health you can imagine' (=100) and 'The worst health you can imagine' (=0). The EQ VAS provides a quantitative measure of the person's perception of their overall health and is used in this study.
Measured: up to 2 weeks
Secondary outcomes (2)
App usage - exercise session length
Exercise session length will be recorded in seconds and is defined by the time spent in each category (endurance, strength, balance, flexicility and relaxation) of provided exercises.
Measured: 7 days
App usage - total duration per session
The duration of each session will be recorded in seconds, based on the time spent with exercises, regardless of the category.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start1 Apr 2024
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to the intervention group or the waitlist control group. The intervention group uses the ActiveWaiting App for a week, the waitlist control group starts with a control period (one week), before using the App for a week.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig Boltzmann Institute for Digital Health and Prevention
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321926
- Sponsor's protocol ID
- 154/2023
- Status last verified
- Jun 2024
- First submitted
- 27 Feb 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the "ActiveWaiting App" Encouraging Active Exercise-related Use of Waiting Time. A Waitlist Control Study
- ClinicalTrials.gov ID
- NCT06321926
- Acronym / sponsor ID
- 154/2023
- Conditions
- Physical Inactivity
- Keywords
- sedentary behaviour, behaviour change, digital health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Ludwig Boltzmann Institute for Digital Health and PreventionUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 20 Mar 2024 (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.
The goal of this study (waitlist control study) is to evaluate the effectiveness of the ActiveWaiting App on increasing physical activity and improving quality of life in physically inactive adults in Austria.
The main questions it aims to answer are:
- Does the provision of the ActiveWaiting App lead to increased physical activity behaviour, compared to a no-intervention control group?
- Does the provision of the ActiveWaiting App lead to increased health-related quality of life, compared to a no-intervention control group? Participants will use the ActiveWaiting App over a period of seven days. During this period, they will answer daily questionnaires (3 - 6 questions) in order to gather their actual physical activity behaviour. Before and after the intervention period additional questionnaires on health-related quality of life will be sent to the participants.
Participants in the waitlist control group will have a control period (seven days) before using the app.
Researchers will compare the intervention group with the waitlist control group to see if the ActiveWating App has an effect
- on physical activity behaviour and
- on quality of life.
Detailed description
A randomized waitlist control design will be chosen to answer the research question. Participants will be randomly assigned to the intervention group or to the waitlist control group. Block randomization with permutated block sizes will ensure that both study arms are recruited evenly over time. Allocation to the groups will be concealed. The waitlist control group will have the opportunity to use the ActiveWaiting App after the control period. Intervention and control period will be 1 week. Demographic data will be collected before randomization.
Additionally to the primary research questions, the following research questions will be addressed for explorative purposes:
- How much is the ActiveWaiting App used for active waiting and breaking time?
- Which category of exercises are used for this purpose?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to the intervention group or the waitlist control group. The intervention group uses the ActiveWaiting App for a week, the waitlist control group starts with a control period (one week), before using the App for a week.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: ActiveWaiting AppParticipants in the intervention group use the ActiveWaiting App for one week. |
| Waitlist control group | Other | Device: ActiveWaiting AppParticipants in the waitlist control group go through a one-week control period without any intervention first, before they are using the app for one week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- a sedentary lifestyle (expressed in a full to part-time sedentary job)
- using a smart phone seven days a week
- ability to operate an app on the smart phone
- age between 18 and 65 years
Key exclusion criteria (2 listed)
- prior usage of the ActiveWaiting App
- achieving the World Health Organization (WHO) recommendations for physical activity (assessed via Rapid Assessment of physical Activity RAPA)
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 |
|---|---|---|
| ActiveWaiting AppThe final prototype aims at increasing physical activity during the day by providing exercises for waiting periods and other idle time periods. The user can choose from a pool of exercises from five different categories (11 exercises for endurance, 65 exercises for strength, 67 exercises for flexibility, 11 exercises for relaxation, or 5 exercises for balance). Additionally, within each category, the user can choose only "discrete" exercises which are not noticeable to an observer. If the user has used the app before, the last or previously saved settings can be chosen. Every input field has an information icon showing a short description of the input field. | Device | Intervention group, Waitlist control group |
Primary outcome
Amount of physical activity in minutes per day
Time frame: up to 2 weeks
Participants are asked to report their physical activity twice a day (noon and evening).
EQ VAS / EQ-5D-5L
Time frame: up to 2 weeks
The EQ VAS (EuroQol Visual Analog Scale) is the last item in the EQ-5D-5L (EuroQol - 5 Dimension - 5 Level) Questionnaire. It records the respondent's overall current health on a visual analogue scale. The endpoints are labelled as 'The best health you can imagine' (=100) and 'The worst health you can imagine' (=0). The EQ VAS provides a quantitative measure of the person's perception of their overall health and is used in this study.
2 secondary outcomes
App usage - exercise session length
Time frame: 7 days
App usage - total duration per session
Time frame: 7 days
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 25 Jun 2024.
- Individual participant dataSharing planned: No
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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 ActiveWaiting App in people with Physical Inactivity, run by Ludwig Boltzmann Institute for Digital Health and Prevention at 1 site in Austria.
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 4 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 25 Jun 2024. 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 Austria. 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?
Amount of physical activity in minutes per day (time frame: up to 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2024.