Risk Reduction BehaviorSMARTpathNCT03094858
Evaluation of a Smartphone Intervention to Reduce Sedentary Behavior
A study testing Smartphone with prompts, Wristband and Smartphone in people with Risk Reduction Behavior, run by University of Oklahoma.
Trial summary
Participants (N = 300) will be randomly assigned to: 1) an equipment-only comparison group that receives a smartphone and an activity monitor wristband but does not receive smartphone intervention prompts, or 2) the intervention group who will receive an activity monitor wristband that works in conjunction with a… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Risk Reduction Behavior
- What is being tested?
- Smartphone with prompts, Wristband and Smartphone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2019to Apr 2020
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A score of ≥ 4 on the REALM-SF85 indicating > 6th grade English literacy level, must be at least 18 years of age
- A BMI ≥ 25 (overweight/obese), not meeting current physical activity guidelines as measured by the 7-Day Physical Activity Recall
- Do not have a contraindication for physical activity based on the Physical Activity Readiness Questionnaire (PAR-Q)
- Able to attend all study visits, and possess a valid home address and a functioning telephone number.
Who cannot join
- Participants who have physical disabilities that restrict lower limb function and/or reading skills below a 7th grade reading level.
About this study
Participants (N = 300) will be randomly assigned to: 1) an equipment-only comparison group that receives a smartphone and an activity monitor wristband but does not receive smartphone intervention prompts, or 2) the intervention group who will receive an activity monitor wristband that works in conjunction with a smartphone to reduce sedentary time via smartphone prompts during prolonged sedentary bouts. All participants will be provided with a Fitbit® wristband activity monitor and an Android smartphone on the same day of the week (i.e., Mondays). Participants will complete a 1-week baseline accelerometer and EMA period prior to the start of the intervention. Participants will be followed for 26 weeks after the intervention begins with follow-up visits at 6, 13, and 26 weeks. The primary outcome will be accelerometer-measured time spent in sedentary activity. Sedentary breaks, total active time, and time spent in light, moderate, and vigorous activity will be additionally evaluated as outcomes. Contextual variables and potential treatment mechanisms will be assessed via traditional questionnaire measurement and daily random EMAs at baseline and all follow-up visits. Brief smartphone-based daily diary assessments will be completed daily for the duration of the study.
- Conditions
- Risk Reduction Behavior
- Being tested
- Smartphone with prompts, Wristband, Smartphone
- Keywords
- Smartphone, sedentary behavior, smartphone intervention
- Medical subject headings
- Risk Reduction Behavior, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone with promptsDevice
Also called Android Smartphone
Smartphone will be used to prompt randomly selected participants in intervention group to be active
WristbandDevice
Also called Fitbit
Wristband will monitor activity of all participants
SmartphoneDevice
Also called Android
Smartphone will be used to monitor activity but prompts will not be given to randomly selected participants
| Study group | Role | What they receive |
|---|---|---|
| Comparison group | Active comparator | Equipment only comparison group will use Smartphone and Wristband to monitor sedentary behavior Receives: Device: Wristband; Device: Smartphone |
| Intervention group | Experimental | Intervention group will receive prompts from Smartphone to reduce sedentary behavior using information from Wristband Receives: Device: Smartphone with prompts; Device: Wristband |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accelerometer-measured sedentary time
Total accelerometer-measured time spent in sedentary activity
Measured: One week
Secondary outcomes (3)
Accelerometer-measured sedentary breaks
Accelerometer-measured time spent in sedentary activity
Measured: 26 weeks
Accelerometer-measured total active time
Total active time
Measured: 26 weeks
Accelerometer-measured time spent in light, moderate, and vigorous activity
Total time spent in light, moderate, and vigorous activity
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start1 Mar 2019 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Why it stopped: The smartwatches we planned to use were discontinued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk Reduction BehaviorStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Darla Kendzor, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094858
- Sponsor's protocol ID
- 7092
- Acronym
- SMARTpath
- Status last verified
- Jun 2021
- First submitted
- 16 Feb 2017
- Last updated
- 11 Jun 2021
- 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 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Smartphone Intervention to Reduce Sedentary Behavior
- ClinicalTrials.gov ID
- NCT03094858
- Acronym / sponsor ID
- SMARTpath / 7092
- Conditions
- Risk Reduction Behavior
- Keywords
- Smartphone, sedentary behavior, smartphone intervention
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The smartwatches we planned to use were discontinued.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 29 Mar 2017 (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.
Participants (N = 300) will be randomly assigned to: 1) an equipment-only comparison group that receives a smartphone and an activity monitor wristband but does not receive smartphone intervention prompts, or 2) the intervention group who will receive an activity monitor wristband that works in conjunction with a smartphone to reduce sedentary time via smartphone prompts during prolonged sedentary bouts. All participants will be provided with a Fitbit® wristband activity monitor and an Android smartphone on the same day of the week (i.e., Mondays). Participants will complete a 1-week baseline accelerometer and EMA period prior to the start of the intervention. Participants will be followed for 26 weeks after the intervention begins with follow-up visits at 6, 13, and 26 weeks. The primary outcome will be accelerometer-measured time spent in sedentary activity. Sedentary breaks, total active time, and time spent in light, moderate, and vigorous activity will be additionally evaluated as outcomes. Contextual variables and potential treatment mechanisms will be assessed via traditional questionnaire measurement and daily random EMAs at baseline and all follow-up visits. Brief smartphone-based daily diary assessments will be completed daily for the duration of the study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparison group | Active comparator | Device: Wristband, Device: SmartphoneEquipment only comparison group will use Smartphone and Wristband to monitor sedentary behavior |
| Intervention group | Experimental | Device: Smartphone with prompts, Device: WristbandIntervention group will receive prompts from Smartphone to reduce sedentary behavior using information from Wristband |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A score of ≥ 4 on the REALM-SF85 indicating > 6th grade English literacy level, must be at least 18 years of age
- A BMI ≥ 25 (overweight/obese), not meeting current physical activity guidelines as measured by the 7-Day Physical Activity Recall
- Do not have a contraindication for physical activity based on the Physical Activity Readiness Questionnaire (PAR-Q)
- Able to attend all study visits, and possess a valid home address and a functioning telephone number.
Key exclusion criteria (1 listed)
- Participants who have physical disabilities that restrict lower limb function and/or reading skills below a 7th grade reading level.
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 with promptsAlso: Android SmartphoneSmartphone will be used to prompt randomly selected participants in intervention group to be active | Device | Intervention group |
| WristbandAlso: FitbitWristband will monitor activity of all participants | Device | Comparison group, Intervention group |
| SmartphoneAlso: AndroidSmartphone will be used to monitor activity but prompts will not be given to randomly selected participants | Device | Comparison group |
Primary outcome
Accelerometer-measured sedentary time
Time frame: One week
Total accelerometer-measured time spent in sedentary activity
3 secondary outcomes
Accelerometer-measured sedentary breaks
Time frame: 26 weeks
Accelerometer-measured total active time
Time frame: 26 weeks
Accelerometer-measured time spent in light, moderate, and vigorous activity
Time frame: 26 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- 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.
Darla Kendzor, PhD principal investigator
University of Oklahoma
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone with prompts, Wristband and Smartphone in people with Risk Reduction Behavior, run by University of Oklahoma.
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 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: withdrawn, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Accelerometer-measured sedentary time (time frame: One week). 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 11 Jun 2021; AzTrials last refreshed its copy on 6 Nov 2026.