Evaluation of the "ActiveWaiting App" Encouraging Active Exercise-related Use of Waiting Time

Physical Inactivity Clinical Trial

Official title:

Evaluation of the "ActiveWaiting App" Encouraging Active Exercise-related Use of Waiting Time. A Waitlist Control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06321926
• Other study ID #: 154/2023
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Ludwig Boltzmann Institute for Digital Health and Prevention
• Contact: Andrea Greisberger, MSc
• Phone: +4316066877
• Email: andrea.greisberger[@]fh-campuswien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Does the provision of the ActiveWaiting App lead to increased physical activity behaviour, compared to a no-intervention control group?

2. 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.

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Physical Inactivity

Intervention

Device:
• ActiveWaiting App
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.

Locations

Country	Name	City	State
Austria	FH Campus Wien	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig Boltzmann Institute for Digital Health and Prevention

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of physical activity in minutes per day	Participants are asked to report their physical activity twice a day (noon and evening).	up to 2 weeks
Primary	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.	up to 2 weeks
Secondary	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.	7 days
Secondary	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.	7 days