Health BehaviorNCT01516411
Promoting Healthy Lifestyles Using Mobile Phones
A study testing Mobile Intervention for Lifestyle Eating/Exercise @ Stanford in people with Health Behavior, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this research is to test programs to increase physical activity and reduce sedentary behavior using motivational messages over a cell phone. Read more about this study
- Who is it for?
- Ages 45 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Mobile Intervention for Lifestyle Eating/Exercise @ Stanford
- 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 siteUnited States
- Study dates
- Oct 2010to Dec 2014
- 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 45 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 45 and older, currently sedentary, owns and uses a cell phone but not a Smartphone, willing to be randomly assigned
Who cannot join
- free of clinically evident cardiovascular disease or any other medical condition or disorder that would limit participation in moderate intensity physical activities akin to brisk walking
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Prevention Research Center
Palo Alto, California, 94305
About this study
The purpose of this research is to test programs to increase physical activity and reduce sedentary behavior using motivational messages over a cell phone.
Read the detailed description
We want to learn if conceptually-based behavioral interventions for promoting increased physical activity and decreased sedentary behavior via state-of-the-art mobile phones will be efficacious at improving these behaviors relative to commercially available Android applications as a control. If efficacious, these types of intervention programs could be disseminated to a wide variety of sedentary and underactive adults at a relatively low cost. This could have a potentially significant impact on promoting improved health such as reduced obesity, a key problem within the U.S.
- Conditions
- Health Behavior
- Being tested
- Mobile Intervention for Lifestyle Eating/Exercise @ Stanford
- Keywords
- Health Promotion, Physical Activity, Sedentary Time, Smartphones
- Medical subject headings
- Health Behavior, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Intervention for Lifestyle Eating/Exercise @ StanfordBehavioural
Participants are randomized to one of 4 groups, each of which uses a different Smartphone app to promote health behavior change
| Study group | Role | What they receive |
|---|---|---|
| Cognitive app | Active comparator | Cognitive app promotes behavior change via goal setting, feedback, and problem solving Receives: Behavioral: Mobile Intervention for Lifestyle Eating/Exercise @ Stanford |
| Social app | Active comparator | Social app promotes behavior change via social relationships and feedback Receives: Behavioral: Mobile Intervention for Lifestyle Eating/Exercise @ Stanford |
| Affect app | Active comparator | Affect app promotes behavior change via game-like elements including the use of a bird avatar as a visual representation of one's activities and operant conditioning Receives: Behavioral: Mobile Intervention for Lifestyle Eating/Exercise @ Stanford |
| Nutrition app | Active comparator | Nutrition app promotes behavior change bvia tracking of food consumption Receives: Behavioral: Mobile Intervention for Lifestyle Eating/Exercise @ Stanford |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent being physically active
Measured: 2 months
Time spent sitting
Measured: 2 months
Changes in food consumption
Measured: 2 months
Secondary outcomes (2)
Beliefs and behaviors about Smartphones
Measured: 2 months
Beliefs and behaviors about the Smartphone application
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startOct 2010
- Primary completionDec 2014
- Study completionDec 2014
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 Health BehaviorStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abby C King, Stanford University
- Investigators
- Abby C King, PhD, Principal investigator, Stanford Prevention Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01516411
- Sponsor's protocol ID
- SU-09162011-8409
- Status last verified
- Dec 2015
- First submitted
- 19 Jan 2012
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
King AC, Hekler EB, Grieco LA, Winter SJ, Sheats JL, Buman MP, Banerjee B, Robinson TN, Cirimele J. Effects of Three Motivationally Targeted Mobile Device Applications on Initial Physical Activity and Sedentary Behavior Change in Midlife and Older Adults: A Randomized Trial. PLoS One. 2016 Jun 28;11(6):e0156370. doi: 10.1371/journal.pone.0156370. eCollection 2016.
PubMed 27352250
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Healthy Lifestyles Using Mobile Phones
- ClinicalTrials.gov ID
- NCT01516411
- Acronym / sponsor ID
- SU-09162011-8409
- Conditions
- Health Behavior
- Keywords
- Health Promotion, Physical Activity, Sedentary Time, Smartphones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Jan 2012 (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 purpose of this research is to test programs to increase physical activity and reduce sedentary behavior using motivational messages over a cell phone.
Detailed description
We want to learn if conceptually-based behavioral interventions for promoting increased physical activity and decreased sedentary behavior via state-of-the-art mobile phones will be efficacious at improving these behaviors relative to commercially available Android applications as a control. If efficacious, these types of intervention programs could be disseminated to a wide variety of sedentary and underactive adults at a relatively low cost. This could have a potentially significant impact on promoting improved health such as reduced obesity, a key problem within the U.S.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cognitive app | Active comparator | Behavioral: Mobile Intervention for Lifestyle Eating/Exercise @ StanfordCognitive app promotes behavior change via goal setting, feedback, and problem solving |
| Social app | Active comparator | Behavioral: Mobile Intervention for Lifestyle Eating/Exercise @ StanfordSocial app promotes behavior change via social relationships and feedback |
| Affect app | Active comparator | Behavioral: Mobile Intervention for Lifestyle Eating/Exercise @ StanfordAffect app promotes behavior change via game-like elements including the use of a bird avatar as a visual representation of one's activities and operant conditioning |
| Nutrition app | Active comparator | Behavioral: Mobile Intervention for Lifestyle Eating/Exercise @ StanfordNutrition app promotes behavior change bvia tracking of food consumption |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged 45 and older, currently sedentary, owns and uses a cell phone but not a Smartphone, willing to be randomly assigned
Key exclusion criteria (1 listed)
- free of clinically evident cardiovascular disease or any other medical condition or disorder that would limit participation in moderate intensity physical activities akin to brisk walking
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 |
|---|---|---|
| Mobile Intervention for Lifestyle Eating/Exercise @ StanfordParticipants are randomized to one of 4 groups, each of which uses a different Smartphone app to promote health behavior change | Behavioural | Affect app, Cognitive app, Nutrition app, Social app |
Primary outcome
Time spent being physically active
Time frame: 2 months
Time spent sitting
Time frame: 2 months
Changes in food consumption
Time frame: 2 months
2 secondary outcomes
Beliefs and behaviors about Smartphones
Time frame: 2 months
Beliefs and behaviors about the Smartphone application
Time frame: 2 months
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 9 Dec 2015.
- Derived from this study: PubMed 27352250King AC, Hekler EB, Grieco LA, Winter SJ, Sheats JL, Buman MP, Banerjee B, Robinson TN, Cirimele J. Effects of Three Motivationally Targeted Mobile Device Applications on Initial Physical Activity and Sedentary Behavior Change in Midlife and Older Adults: A Randomized Trial. PLoS One. 2016 Jun 28;11(6):e0156370. doi: 10.1371/journal.pone.0156370. eCollection 2016.
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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.
Abby C King, PhD principal investigator
Stanford Prevention Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Intervention for Lifestyle Eating/Exercise @ Stanford in people with Health Behavior, run by Stanford University 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 1 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 9 Dec 2015. 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?
Time spent being physically active (time frame: 2 months). The study lists 3 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 NCT01516411, 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 9 Dec 2015.