- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06321926
Evaluation of the "ActiveWaiting App" Encouraging Active Exercise-related Use of Waiting Time
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:
- 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.
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Vienna, Austria
- FH Campus Wien
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- prior usage of the ActiveWaiting App
- achieving the World Health Organization (WHO) recommendations for physical activity (assessed via Rapid Assessment of physical Activity RAPA)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
Participants in the intervention group use the ActiveWaiting App for one week.
|
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.
|
|
Other: Waitlist control group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
up to 2 weeks
|
|
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.
|
up to 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
App usage - exercise session length
Time Frame: 7 days
|
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.
|
7 days
|
|
App usage - total duration per session
Time Frame: 7 days
|
The duration of each session will be recorded in seconds, based on the time spent with exercises, regardless of the category.
|
7 days
|
Collaborators and Investigators
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
- 154/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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