Sedentary LifestyleNCT02886871
CalFitness Smartphone-Delivered Physical Activity Intervention
A study testing Step Goal Delivery by Smartphone in people with Sedentary Lifestyle and Physical Activity, run by University of California, Berkeley at 1 site in United States.
Trial summary
The overall goal of this study is to test personalized mobile phone-based physical activity interventions among staff members at the University of California, Berkeley. Most physical fitness applications for smartphones and activity trackers use a constant goal for the number of steps each day. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle, Physical Activity
- What is being tested?
- Step Goal Delivery by Smartphone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Dec 2016
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- intent to become physically active
- own an iPhone
- willing to keep the iPhone in pockets during the day
- willing to install and use the intervention app every day for 4 months
- ability to speak and read English.
Who cannot join
- known medical conditions or physical problems that require special attention in an exercise program
- planning an international trip during the next 4 months, which could interfere with daily server uploads of mobile phone data
- pregnant/gave birth during the past 6 months
- severe hearing or speech problem
- history of an eating disorder
- current substance abuse
- current participation in lifestyle modification programs or research studies that may confound study results
- history of bariatric surgery or plans for bariatric surgery in the next 12 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Berkeley
Berkeley, California, 94720
About this study
Official title: Mobile Phone-Based Physical Activity Intervention on University Staff
The overall goal of this study is to test personalized mobile phone-based physical activity interventions among staff members at the University of California, Berkeley. Most physical fitness applications for smartphones and activity trackers use a constant goal for the number of steps each day. However, if the step goals are dynamically adjusted according to past behavior, then the corresponding goals may encourage individuals to increase their physical activity level. This study consists of a randomized controlled trial in which we are assessing the efficacy of two different algorithms for calculating personalized goals for the number of steps each day.
- Conditions
- Sedentary Lifestyle, Physical Activity
- Being tested
- Step Goal Delivery by Smartphone
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step Goal Delivery by SmartphoneBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Personalized Steps Goal | Experimental | Step Goal Delivery by Smartphone Receives: Behavioral: Step Goal Delivery by Smartphone |
| Constant Steps Goal | Active comparator | Step Goal Delivery by Smartphone Receives: Behavioral: Step Goal Delivery by Smartphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Steps Taken Per Day
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2016
- Study completionDec 2016
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 Sedentary LifestyleStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anil Aswani, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886871
- Sponsor's protocol ID
- 2016-03-8609-1
- Status last verified
- Oct 2018
- First submitted
- 29 Aug 2016
- Last updated
- 10 Oct 2018
- Results posted
- No
Publications
Zhou M, Fukuoka Y, Mintz Y, Goldberg K, Kaminsky P, Flowers E, Aswani A. Evaluating Machine Learning-Based Automated Personalized Daily Step Goals Delivered Through a Mobile Phone App: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Jan 25;6(1):e28. doi: 10.2196/mhealth.9117.
PubMed 29371177
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Phone-Based Physical Activity Intervention on University Staff
- ClinicalTrials.gov ID
- NCT02886871
- Acronym / sponsor ID
- 2016-03-8609-1
- Conditions
- Sedentary Lifestyle, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 1 Sep 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 overall goal of this study is to test personalized mobile phone-based physical activity interventions among staff members at the University of California, Berkeley. Most physical fitness applications for smartphones and activity trackers use a constant goal for the number of steps each day. However, if the step goals are dynamically adjusted according to past behavior, then the corresponding goals may encourage individuals to increase their physical activity level. This study consists of a randomized controlled trial in which we are assessing the efficacy of two different algorithms for calculating personalized goals for the number of steps each day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized Steps Goal | Experimental | Behavioral: Step Goal Delivery by SmartphoneStep Goal Delivery by Smartphone |
| Constant Steps Goal | Active comparator | Behavioral: Step Goal Delivery by SmartphoneStep Goal Delivery by Smartphone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- intent to become physically active
- own an iPhone
- willing to keep the iPhone in pockets during the day
- willing to install and use the intervention app every day for 4 months
- ability to speak and read English.
Key exclusion criteria (8 listed)
- known medical conditions or physical problems that require special attention in an exercise program
- planning an international trip during the next 4 months, which could interfere with daily server uploads of mobile phone data
- pregnant/gave birth during the past 6 months
- severe hearing or speech problem
- history of an eating disorder
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 |
|---|---|---|
| Step Goal Delivery by Smartphone | Behavioural | Constant Steps Goal, Personalized Steps Goal |
Primary outcome
Daily Steps Taken Per Day
Time frame: 10 weeks
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 10 Oct 2018.
- Derived from this study: PubMed 29371177Zhou M, Fukuoka Y, Mintz Y, Goldberg K, Kaminsky P, Flowers E, Aswani A. Evaluating Machine Learning-Based Automated Personalized Daily Step Goals Delivered Through a Mobile Phone App: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Jan 25;6(1):e28. doi: 10.2196/mhealth.9117.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Step Goal Delivery by Smartphone in people with Sedentary Lifestyle and Physical Activity, run by University of California, Berkeley at 1 site in United States.
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 8 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 10 Oct 2018. 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 United States. 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?
Daily Steps Taken Per Day (time frame: 10 weeks). 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 NCT02886871, 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 10 Oct 2018.