Physical ActivityNCT02948803
A Smartphone-based Intervention to Promote an Active Lifestyle in Low Educated Working Young Adults
A study testing smartphone based intervention with Active Coach app in people with Physical Activity, run by University Ghent at 1 site in Belgium.
Trial summary
The aim of this smartphone-based intervention study is to determine whether a newly developed app is effective in promoting an active lifestyle in low educated working young adults. Read more about this study
- Who is it for?
- Ages 18 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- smartphone based intervention with Active Coach app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Sep 2016to 17 Feb 2017
- 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 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- between 18 and 28 years old
- low educated (maximum secondary school, no higher education (university or college)
- employed
- dutch speaking
- owning an Android smartphone
Who cannot join
- being very physically active (already reaching the recommended 30 minutes of physical activity a day)
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this smartphone-based intervention study is to determine whether a newly developed app is effective in promoting an active lifestyle in low educated working young adults.
Read the detailed description
A stepwise approach was used to develop a new native Android smartphone app (Active Coach). This app aims to promote an active lifestyle (through physical activity and active transport) in low educated working young adults. The development of this app is based on theory, evidence and user's experiences. The app focuses on four determinants (knowledge, attitude (perceived benefits and perceived barriers), social support and self-efficacy) and includes several behavioral change techniques (self-monitoring, goal-setting, feedback on behavior, review behavior goals, instruction on how to perform the behavior, information about health consequences, enhancing network linkages and prompts/cues). Furthermore, the app works in combinations with a wearable activity tracker (Fitbit Charge) to track users activity behavior.
For the smartphone-based intervention, 120 low educated working young adults are being recruited via purposeful convenience sampling though companies and employers. Participants can not have any medical conditions that prevent them from being physically active and they need to own an Android smartphone. Fitbit Charge activity trackers will be provided. The participants will be randomly divided in the intervention group or the standard information control group. The intervention period will be nine weeks. At the beginning and the end of the intervention period, physical activity levels will be objectively measured with accelerometers. Follow-up measurements will be conducted 12 weeks after the end of the intervention period.
- Conditions
- Physical Activity
- Being tested
- smartphone based intervention with Active Coach app
- Keywords
- intervention, mHealth, physical activity, active transport, smartphone, application
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smartphone based intervention with Active Coach appBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | smartphone based intervention with Active Coach app: participants in the intervention group will use a newly developed smartphone app in combination with a Fitbit Charge activity tracker for 9 weeks. The app aims to promote an active lifestyle. Receives: Behavioral: smartphone based intervention with Active Coach app |
| control group | No intervention | participants in the control groups only receive a flyer with standard information about an active lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in physical activity: objective
physical activity will be objectively measured by accelerometers (Actigraph)
Measured: The outcome will be measured at baseline (before start intervention), posttest (9 weeks after the start of the intervention) and follow-up (12 weeks after the posttest)
change in physical activity: self-reported
physical activity will be measured via the International Physical Activity Questionnaire (IPAQ, long version)
Measured: The outcome will be measured at baseline (before start intervention), posttest (9 weeks after the start of the intervention) and follow-up (12 weeks after the posttest)
Secondary outcomes (5)
Change in perceived benefits towards physical activity and active transport
benefits will be measured via fifteen items with a five-point answer format
Measured: The outcome will be measured at baseline (before start intervention), posttest (9 weeks after the start of the intervention) and follow-up (12 weeks after the posttest)
Change in perceived barriers towards physical activity and active transport
barriers will be measured via fifteen items with a five-point answer format
Measured: The outcome will be measured at baseline (before start intervention), posttest (9 weeks after the start of the intervention) and follow-up (12 weeks after the posttest)
Change in social support towards physical activity and active transport
social support will be measured via nine items with a five-point answer format
Measured: The outcome will be measured at baseline (before start intervention), posttest (9 weeks after the start of the intervention) and follow-up (12 weeks after the posttest)
Change in self-efficacy towards physical activity and active transport
self-efficacy will be measured via eight items with a five-point answer format
Measured: The outcome will be measured at baseline (before start intervention), posttest (9 weeks after the start of the intervention) and follow-up (12 weeks after the posttest)
Change in knowledge towards physical activity and active transport
knowledge will be measured via one item with a six-point answer format
Measured: The outcome will be measured at baseline (before start intervention), posttest (9 weeks after the start of the intervention) and follow-up (12 weeks after the posttest)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study start12 Sep 2016
- Primary completion17 Feb 2017
- Study completion17 Feb 2017
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.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- pre, post, follow up measurements with an intervention and control group
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Responsible party
- Sponsor
- Investigators
- Dorien Simons, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948803
- Sponsor's protocol ID
- 11U8114N
- Status last verified
- Aug 2017
- First submitted
- 6 Oct 2016
- Last updated
- 21 Aug 2017
- Results posted
- No
- Individual data sharing
- No
Publications
Simons D, De Bourdeaudhuij I, Clarys P, De Cocker K, Vandelanotte C, Deforche B. Effect and Process Evaluation of a Smartphone App to Promote an Active Lifestyle in Lower Educated Working Young Adults: Cluster Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Aug 24;6(8):e10003. doi: 10.2196/10003.
PubMed 30143477
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Smartphone-based Intervention to Promote an Active Lifestyle in Low Educated Working Young Adults
- ClinicalTrials.gov ID
- NCT02948803
- Acronym / sponsor ID
- 11U8114N
- Conditions
- Physical Activity
- Keywords
- intervention, mHealth, physical activity, active transport, smartphone, application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Study start
- 12 Sep 2016 (actual)
- Primary completion
- 17 Feb 2017 (actual)
- Study completion
- 17 Feb 2017 (actual)
- First posted
- 28 Oct 2016 (estimated)
- 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 aim of this smartphone-based intervention study is to determine whether a newly developed app is effective in promoting an active lifestyle in low educated working young adults.
Detailed description
A stepwise approach was used to develop a new native Android smartphone app (Active Coach). This app aims to promote an active lifestyle (through physical activity and active transport) in low educated working young adults. The development of this app is based on theory, evidence and user's experiences. The app focuses on four determinants (knowledge, attitude (perceived benefits and perceived barriers), social support and self-efficacy) and includes several behavioral change techniques (self-monitoring, goal-setting, feedback on behavior, review behavior goals, instruction on how to perform the behavior, information about health consequences, enhancing network linkages and prompts/cues). Furthermore, the app works in combinations with a wearable activity tracker (Fitbit Charge) to track users activity behavior.
For the smartphone-based intervention, 120 low educated working young adults are being recruited via purposeful convenience sampling though companies and employers. Participants can not have any medical conditions that prevent them from being physically active and they need to own an Android smartphone. Fitbit Charge activity trackers will be provided. The participants will be randomly divided in the intervention group or the standard information control group. The intervention period will be nine weeks. At the beginning and the end of the intervention period, physical activity levels will be objectively measured with accelerometers. Follow-up measurements will be conducted 12 weeks after the end of the intervention period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- pre, post, follow up measurements with an intervention and control group
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: smartphone based intervention with Active Coach appsmartphone based intervention with Active Coach app: participants in the intervention group will use a newly developed smartphone app in combination with a Fitbit Charge activity tracker for 9 weeks. The app aims to promote an active lifestyle. |
| control group | No intervention | –participants in the control groups only receive a flyer with standard information about an active lifestyle |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- between 18 and 28 years old
- low educated (maximum secondary school, no higher education (university or college)
- employed
- dutch speaking
- owning an Android smartphone
Key exclusion criteria (1 listed)
- being very physically active (already reaching the recommended 30 minutes of physical activity a day)
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 |
|---|---|---|
| smartphone based intervention with Active Coach app | Behavioural | Intervention group |
Primary outcome
change in physical activity: objective
Time frame: The outcome will be measured at baseline (before start intervention), posttest (9 weeks after the start of the intervention) and follow-up (12 weeks after the posttest)
physical activity will be objectively measured by accelerometers (Actigraph)
change in physical activity: self-reported
Time frame: The outcome will be measured at baseline (before start intervention), posttest (9 weeks after the start of the intervention) and follow-up (12 weeks after the posttest)
physical activity will be measured via the International Physical Activity Questionnaire (IPAQ, long version)
5 secondary outcomes
Change in perceived benefits towards physical activity and active transport
Time frame: The outcome will be measured at baseline (before start intervention), posttest (9 weeks after the start of the intervention) and follow-up (12 weeks after the posttest)
Change in perceived barriers towards physical activity and active transport
Time frame: The outcome will be measured at baseline (before start intervention), posttest (9 weeks after the start of the intervention) and follow-up (12 weeks after the posttest)
Change in social support towards physical activity and active transport
Time frame: The outcome will be measured at baseline (before start intervention), posttest (9 weeks after the start of the intervention) and follow-up (12 weeks after the posttest)
Change in self-efficacy towards physical activity and active transport
Time frame: The outcome will be measured at baseline (before start intervention), posttest (9 weeks after the start of the intervention) and follow-up (12 weeks after the posttest)
Change in knowledge towards physical activity and active transport
Time frame: The outcome will be measured at baseline (before start intervention), posttest (9 weeks after the start of the intervention) and follow-up (12 weeks after the posttest)
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 21 Aug 2017.
- Derived from this study: PubMed 30143477Simons D, De Bourdeaudhuij I, Clarys P, De Cocker K, Vandelanotte C, Deforche B. Effect and Process Evaluation of a Smartphone App to Promote an Active Lifestyle in Lower Educated Working Young Adults: Cluster Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Aug 24;6(8):e10003. doi: 10.2196/10003.
- 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.
Dorien Simons principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smartphone based intervention with Active Coach app in people with Physical Activity, run by University Ghent at 1 site in Belgium.
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 5 inclusion and 1 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 21 Aug 2017. 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 Belgium. 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?
change in physical activity: objective (time frame: The outcome will be measured at baseline (before start intervention), posttest (9 weeks after the start of the intervention) and follow-up (12 weeks after the posttest)). 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?
On the ClinicalTrials.gov record for NCT02948803, 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 21 Aug 2017.