Physical ActivityNCT04043650
Developing Dynamic Theories for Behavior Change
A study testing HeartSteps in people with Physical Activity, run by University of Southern California at 1 site in United States.
Trial summary
The aim of this research is to evaluate the efficacy of contextually tailored activity suggestions and activity planning for increasing physical activity among sedentary adults. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- HeartSteps
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2020to 31 Aug 2022
- 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
- Individuals are able to participate in mild or moderate physical activity
- They are competent to give informed consent
- Individuals are regular (daily) users of a smartphone (iPhone or Android)
- Individuals are willing to participate in the study protocols, including regularly carrying a mobile phone, using the HeartSteps application, answering phone-based questionnaires, and tracking their physical activity using the Fitbit Versa activity tracker
- Body Mass Index (BMI, weight in kilograms (kg) divided by height in meters squared) between 25--45
- Able to walk one mile without significant discomfort.
Who cannot join
- Being mentally incapable of giving informed consent
- Current enrollment in a formal exercise program
- Psychiatric disorder which limits patients' ability to follow the study protocol, including psychosis or dementia
- Orthopedic problems that prevent participation in a walking program
- Significant peripheral neuropathy
- Severe cognitive impairment
- Pregnancy
- Non-English speaking.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90032
About this study
Official title: Operationalizing Behavioral Theory for mHealth: Dynamics, Context, and Personalization
The aim of this research is to evaluate the efficacy of contextually tailored activity suggestions and activity planning for increasing physical activity among sedentary adults.
Read the detailed description
Unhealthy behaviors contribute to the majority of chronic diseases, which account for 86% of all healthcare spending in the US. Despite a great deal of research, the development of behavior change interventions that are effective, scalable, and sustainable remains challenging. Recent advances in mobile sensing and smartphone-based technologies have led to a novel and promising form of intervention, called a "Just-in-time, adaptive intervention" (JITAI), which has the potential to continuously adapt to changing contexts and personalize to individual needs and opportunities for behavior change. Although interventions have been shown to be more effective when based on sound theory, current behavioral theories lack the temporal granularity and multiscale dynamic structure needed for developing effective JITAIs based on measurements of complex dynamic behaviors and contexts. Simultaneously, there is a lack of modeling frameworks that can express dynamic, temporally multiscale theories and represent dynamic, temporally multiscale data. This project will address the theory-development, measurement, and modeling challenges and opportunities presented by intensively collected longitudinal data, with a focus on physical activity and sedentary behavior, and broad implications for other behaviors.
For efficiency, the study builds on the NIH-funded year-long micro- randomized trial (MRT) of HeartSteps (n=60), an adaptive mHealth intervention based on Social- Cognitive Theory (SCT) developed to increase walking and decrease sedentary behavior in patients with cardiovascular disease. The aims of this new proposal are: 1) Refine and develop dynamic measures of theoretical constructs that influence the study's target behaviors, 2) Enhance HeartSteps with the measures developed in Aim 1 and collect data from two additional year-long HeartSteps cohorts (sedentary overweight/obese adults (n=60) and type 2 diabetes patients (n=60), total n=180), 3) Develop a modeling framework to operationalize dynamic and contextualized theories of behavior in an intervention setting, and 4) Improve prediction of SCT outcomes using increasingly complex models. The work proposed here will provide new digital, data driven measures of key behavioral theory constructs at the momentary, daily, and weekly time scales, provide new tools tailored for the specification of complex models of behavioral dynamics, as well as new model estimation tools tailored specifically to the complex, longitudinal, multi-time scale behavioral and contextual data that are now accessible using mHealth technologies. Finally, the investigators will leverage the collected data and the proposed modeling tools to develop and test enhanced, dynamic extensions of social cognitive theory operationalized as fully quantified, predictive dynamical models. Collectively, this work will provide the theoretical foundations and tools needed to significantly increase the effectiveness of physical activity-based mobile health interventions over multiple time scales, including their ability to effectively support behavior change over longer time scales.
- Conditions
- Physical Activity
- Being tested
- HeartSteps
- Keywords
- Physical Activity, Mobile Health, Self Monitoring, Wearable Sensors, Tailored Health Communication, Implementation Intentions, Mobile Apps, Anti-Sedentary Behavior, Opportunistic Physical Activity, Health Belief Model
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartStepsBehavioural
Also called A just-in-time intervention for increasing physical activity among sedentary adults
HeartSteps is a smartphone based mHealth intervention that contains the following intervention components: (1) contextually-tailored suggestions for activity; (2) motivational messages aimed at keeping individuals motivated to be active; (3) planning of the next week's activity; and (4) adaptive weekly activity goals. Activity suggestions provide individuals with suggestions for how they can be active, and are tailored based on time of day, user's location, day of the week (weekend/weekday), and weather. Motivational messages are delivered to individuals via a push notification. Activity planning asks users to create a plan of how they will be active in the coming week. Participants are prompted to plan once a week. Each week, as part of the weekly planning, HeartSteps suggests an activity goal for the coming week based on their activity levels the previous week. Participants can edit the suggested goal, and the system-suggested goals top out at 150 minutes of activity per week.
| Study group | Role | What they receive |
|---|---|---|
| HeartSteps Intervention | Experimental | For activity suggestions, at each available decision time, each participant is randomly assigned to either receive an activity suggestion or not. Receives: Behavioral: HeartSteps |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 minute step count
step count within the 30-minute window after each available decision point when activity suggestions are randomized. Assessed using the Fitbit Versa Activity tracker.
Measured: 30 minutes
Daily step count
Daily step count on the day of treatment. Assessed using the Fitbit Versa activity tracker.
Measured: 24 hours
Secondary outcomes (1)
Moderate or Vigorous Physical Activity (MVPA)
Number of minutes of moderate or vigorous physical activity
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start10 Jun 2020
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- At each "decision time"-a time point when an intervention component can be delivered-each day of the study each participant is randomized between intervention or no intervention (delivery of a contextually tailored activity suggestion or no suggestion; morning motivational message or no motivational message)
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego, Arizona State University, Kaiser Permanente, Northeastern University, University of Massachusetts, Amherst
- Responsible party
- Principal investigator, Donna Spruijt-Metz, University of Southern California
- Investigators
- Donna Spruijt-Metz, MFA, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043650
- Sponsor's protocol ID
- UP-18-00791
- Status last verified
- Oct 2022
- First submitted
- 31 Jul 2019
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified dataset (i.e., containing no raw location/GPS information) will be generated and made available to the research community. The dataset will be stripped of all codes or any other information that could be linked back to the original data or to an individual participant. Prospective users of this dataset must agree to a confidentiality agreement, meaning that they must get permission from the HeartSteps Primary Investigator to share the data with anyone else. All external requests for data will be directed to Dr. Donna Spruijt-Metz. Prospective investigators will submit a written proposal to the HeartSteps Investigator Team outlining the question they will investigate, the specific variables that they need to answer that question, their analytic plan for answering that question, and documentation of sufficient Institutional Review Board oversight (e.g., approval or exemption). Investigators will also need to sign a confidentiality agreement.
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operationalizing Behavioral Theory for mHealth: Dynamics, Context, and Personalization
- ClinicalTrials.gov ID
- NCT04043650
- Acronym / sponsor ID
- UP-18-00791
- Conditions
- Physical Activity
- Keywords
- Physical Activity, Mobile Health, Self Monitoring, Wearable Sensors, Tailored Health Communication, Implementation Intentions, Mobile Apps, Anti-Sedentary Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- University of California, San Diego, Arizona State University, Kaiser Permanente, Northeastern University, University of Massachusetts, Amherst
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 2 Aug 2019 (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.
The aim of this research is to evaluate the efficacy of contextually tailored activity suggestions and activity planning for increasing physical activity among sedentary adults.
Detailed description
Unhealthy behaviors contribute to the majority of chronic diseases, which account for 86% of all healthcare spending in the US. Despite a great deal of research, the development of behavior change interventions that are effective, scalable, and sustainable remains challenging. Recent advances in mobile sensing and smartphone-based technologies have led to a novel and promising form of intervention, called a "Just-in-time, adaptive intervention" (JITAI), which has the potential to continuously adapt to changing contexts and personalize to individual needs and opportunities for behavior change. Although interventions have been shown to be more effective when based on sound theory, current behavioral theories lack the temporal granularity and multiscale dynamic structure needed for developing effective JITAIs based on measurements of complex dynamic behaviors and contexts. Simultaneously, there is a lack of modeling frameworks that can express dynamic, temporally multiscale theories and represent dynamic, temporally multiscale data. This project will address the theory-development, measurement, and modeling challenges and opportunities presented by intensively collected longitudinal data, with a focus on physical activity and sedentary behavior, and broad implications for other behaviors.
For efficiency, the study builds on the NIH-funded year-long micro- randomized trial (MRT) of HeartSteps (n=60), an adaptive mHealth intervention based on Social- Cognitive Theory (SCT) developed to increase walking and decrease sedentary behavior in patients with cardiovascular disease. The aims of this new proposal are: 1) Refine and develop dynamic measures of theoretical constructs that influence the study's target behaviors, 2) Enhance HeartSteps with the measures developed in Aim 1 and collect data from two additional year-long HeartSteps cohorts (sedentary overweight/obese adults (n=60) and type 2 diabetes patients (n=60), total n=180), 3) Develop a modeling framework to operationalize dynamic and contextualized theories of behavior in an intervention setting, and 4) Improve prediction of SCT outcomes using increasingly complex models. The work proposed here will provide new digital, data driven measures of key behavioral theory constructs at the momentary, daily, and weekly time scales, provide new tools tailored for the specification of complex models of behavioral dynamics, as well as new model estimation tools tailored specifically to the complex, longitudinal, multi-time scale behavioral and contextual data that are now accessible using mHealth technologies. Finally, the investigators will leverage the collected data and the proposed modeling tools to develop and test enhanced, dynamic extensions of social cognitive theory operationalized as fully quantified, predictive dynamical models. Collectively, this work will provide the theoretical foundations and tools needed to significantly increase the effectiveness of physical activity-based mobile health interventions over multiple time scales, including their ability to effectively support behavior change over longer time scales.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- At each "decision time"-a time point when an intervention component can be delivered-each day of the study each participant is randomized between intervention or no intervention (delivery of a contextually tailored activity suggestion or no suggestion; morning motivational message or no motivational message)
| Arm | Type | Receives |
|---|---|---|
| HeartSteps Intervention | Experimental | Behavioral: HeartStepsFor activity suggestions, at each available decision time, each participant is randomly assigned to either receive an activity suggestion or not. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals are able to participate in mild or moderate physical activity
- They are competent to give informed consent
- Individuals are regular (daily) users of a smartphone (iPhone or Android)
- Individuals are willing to participate in the study protocols, including regularly carrying a mobile phone, using the HeartSteps application, answering phone-based questionnaires, and tracking their physical activity using the Fitbit Versa activity tracker
- Body Mass Index (BMI, weight in kilograms (kg) divided by height in meters squared) between 25--45
Key exclusion criteria (8 listed)
- Being mentally incapable of giving informed consent
- Current enrollment in a formal exercise program
- Psychiatric disorder which limits patients' ability to follow the study protocol, including psychosis or dementia
- Orthopedic problems that prevent participation in a walking program
- Significant peripheral neuropathy
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 |
|---|---|---|
| HeartStepsAlso: A just-in-time intervention for increasing physical activity among sedentary adultsHeartSteps is a smartphone based mHealth intervention that contains the following intervention components: (1) contextually-tailored suggestions for activity; (2) motivational messages aimed at keeping individuals motivated to be active; (3) planning of the next week's activity; and (4) adaptive weekly activity goals. Activity suggestions provide individuals with suggestions for how they can be active, and are tailored based on time of day, user's location, day of the week (weekend/weekday), and weather. Motivational messages are delivered to individuals via a push notification. Activity planning asks users to create a plan of how they will be active in the coming week. Participants are prompted to plan once a week. Each week, as part of the weekly planning, HeartSteps suggests an activity goal for the coming week based on their activity levels the previous week. Participants can edit the suggested goal, and the system-suggested goals top out at 150 minutes of activity per week. | Behavioural | HeartSteps Intervention |
Primary outcome
30 minute step count
Time frame: 30 minutes
step count within the 30-minute window after each available decision point when activity suggestions are randomized. Assessed using the Fitbit Versa Activity tracker.
Daily step count
Time frame: 24 hours
Daily step count on the day of treatment. Assessed using the Fitbit Versa activity tracker.
1 secondary outcome
Moderate or Vigorous Physical Activity (MVPA)
Time frame: 24 hours
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 24 Oct 2022.
- Individual participant dataSharing planned: Yes. A de-identified dataset (i.e., containing no raw location/GPS information) will be generated and made available to the research community. The dataset will be stripped of all codes or any other information that could be linked back to the original data or to an individual participant. Prospective users of this dataset must agree to a confidentiality agreement, meaning that they must get permission from the HeartSteps Primary Investigator to share the data with anyone else. All external requests for data will be directed to Dr. Donna Spruijt-Metz. Prospective investigators will submit a written proposal to the HeartSteps Investigator Team outlining the question they will investigate, the specific variables that they need to answer that question, their analytic plan for answering that question, and documentation of sufficient Institutional Review Board oversight (e.g., approval or exemption). Investigators will also need to sign a confidentiality agreement.
Related trials for Physical Activity
Not yet recruitingPhase 1/2
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Active, not recruitingPhase 2
A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy
Thymoma, Thymic Carcinoma
Recruiting
Stress Modulation and Dynamic Balance
Stress
Recruiting
Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR)
Knee Osteoarthristis
RecruitingPhase 1
Imatinib to Increase RUNX1 Activity in Participants With Germline RUNX1 Deficiency
Inherited Bone Marrow Failure Syndrome, Familial Platelet Disorder With Predisposition to Myeloid Malignancies
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.
Donna Spruijt-Metz, MFA, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeartSteps in people with Physical Activity, run by University of Southern California 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 6 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 24 Oct 2022. 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?
30 minute step count (time frame: 30 minutes). 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?
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 24 Oct 2022.