- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02948803
A Smartphone-based Intervention to Promote an Active Lifestyle in Low Educated Working Young Adults
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ghent, Belgium, 9000
- Ghent University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- between 18 and 28 years old
- low educated (maximum secondary school, no higher education (university or college)
- employed
- dutch speaking
- owning an Android smartphone
Exclusion Criteria:
- being very physically active (already reaching the recommended 30 minutes of physical activity a day)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
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.
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No Intervention: control group
participants in the control groups only receive a flyer with standard information about an active lifestyle
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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physical activity will be objectively measured by accelerometers (Actigraph)
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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)
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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)
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physical activity will be measured via the International Physical Activity Questionnaire (IPAQ, long version)
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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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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benefits will be measured via fifteen items with a five-point answer format
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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)
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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)
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barriers will be measured via fifteen items with a five-point answer format
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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)
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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)
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social support will be measured via nine items with a five-point answer format
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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)
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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)
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self-efficacy will be measured via eight items with a five-point answer format
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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)
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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)
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knowledge will be measured via one item with a six-point answer format
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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)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dorien Simons, University Ghent
Publications and helpful links
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 (Estimate)
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
- 11U8114N
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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