Physical ActivityHSNCT03225521
A Micro-randomized Trial of HeartSteps, an mHealth Intervention for Increasing Physical Activity
A study testing HeartSteps: A just-in-time adaptive intervention for increasing physical activity amongst sedentary adults. in people with Physical Activity, run by Kaiser Permanente.
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 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- HeartSteps: A just-in-time adaptive intervention for increasing physical activity amongst sedentary adults.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 18 Jul 2015to 1 Feb 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- English speakers,
- between 18 and 60 years of age,
- could walk for exercise without discomfort, and
- either had a full-time daytime job or a regular schedule outside the home (e.g., students)
- have a personal phone running Android 5.0 or higher or willing to use a study-provided phone as their primary phone for the duration of the study.
Who cannot join
- Need medical supervision to exercise
- Currently using an activity tracker (e.g., FitBit)
About this study
Official title: HeartSteps: a Just-in-Time Adaptive Intervention for Increasing Physical Activity Amongst Sedentary Adults.
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
Physical activity is a key behavioral strategy for prevention of non-communicable diseases such as diabetes and heart disease. Mobile health (mHealth) interventions have shown promise for supporting physical activity adoption and maintenance in ways that are highly acceptable to users, scalable, and cost-efficient. This study examines two intervention strategies-contextually tailored activity suggestions and daily planning of the activity for the next day-that a mobile health intervention can use to encourage physical activity in sedentary adults.
Study participants use HeartSteps, an mHealth physical intervention developed by the research team, in their daily lives for six weeks. Over the course of the study both of the HeartSteps intervention components-contextually-tailored activity suggestions and activity planning-are micro-randomized for each participant on each of the day of the study, in order the effects on physical activity of each component separately and how those effects change over time.
The primary hypothesis for suggestions is that providing a contextually tailored activity suggestion increases participant step count over the subsequent 30 minutes following message delivery.
The first secondary hypothesis for suggestions is that the proximal effect of the contextually tailored activity suggestions on the subsequent 30-minute step count will decrease with duration in the study.
The primary hypothesis for planning is that receiving evening planning will increase step count on the following day.
The primary analyses will use the methods developed in Boruvka et al. (2017). The primary longitudinal outcome for activity suggestions will be the log of the step count in the 30 minutes subsequent to decision points. The log of the step count in the 30 minutes prior to randomization will be included as a control variable. The primary longitudinal outcome for planning will be the square root of the step count on the day following the randomization of planning treatment.
All missing but "available" minute-by-minute step counts from the wrist band will be imputed as 0. See "Allocation" section for the definition of availability. Sensitivity analyses using step counts from the mobile phone (secondary data source) will be conducted.
- Conditions
- Physical Activity
- Being tested
- HeartSteps: A just-in-time adaptive intervention for increasing physical activity amongst sedentary adults.
- 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.
HeartSteps: A just-in-time adaptive intervention for increasing physical activity amongst sedentary adults.Behavioural
HeartSteps is an Android-based mHealth intervention that contains two main intervention components: contextually-tailored suggestions for activity and planning of the next day's activity. Activity suggestions provide individuals with actionable suggestions for how they can be active in their current context. Delivered suggestions are tailored based on time of day, user's location, day of the week (weekend/weekday), and weather. HeartSteps can deliver a user activity suggestions up to five times a day. Evening planning asks users to create or choose a plan of how they will be active on the following day. Planning can be delivered once a day, in the evening.
| 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. The randomization probability is 0.6 for receiving a message and 0.4 for not receiving a message.
For activity planning, at each decision point, the participant is randomized to either receive evening planning or not at that decision time. The randomization probability for receiving planning is 0.5, and 0.5 for not receiving planning. Receives: Behavioral: HeartSteps: A just-in-time adaptive intervention for increasing physical activity amongst sedentary adults. |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 minute step count
30-minute window after each available decision point
Measured: 30 minutes
Daily step count
Daily step count on the day following treatment
Measured: 24 hour day
Secondary outcomes (1)
Thumbs up/down
User ratings of message usefulness (thumbs up/thumbs down rating)
Measured: 30-minute window while message is available
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start18 Jul 2015
- Primary completion1 Feb 2016
- Study completion1 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant-time point is randomized between intervention or no intervention (delivery of a contextually tailored activity suggestion or no suggestion; planning or no planning)
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225521
- Sponsor's protocol ID
- HUM00103127
- Other IDs
- 5R01HL125440
- Acronym
- HS
- Status last verified
- Oct 2018
- First submitted
- 19 Jul 2017
- Last updated
- 25 Oct 2018
- 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. Predrag Klasnja. 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.
Publications
Boruvka A, Almirall D, Witkiewitz K, Murphy SA. Assessing Time-Varying Causal Effect Moderation in Mobile Health. J Am Stat Assoc. 2018;113(523):1112-1121. doi: 10.1080/01621459.2017.1305274. Epub 2017 Mar 29.
PubMed 30467446Klasnja P, Hekler EB, Shiffman S, Boruvka A, Almirall D, Tewari A, Murphy SA. Microrandomized trials: An experimental design for developing just-in-time adaptive interventions. Health Psychol. 2015 Dec;34S(0):1220-8. doi: 10.1037/hea0000305.
PubMed 26651463Liao P, Klasnja P, Tewari A, Murphy SA. Sample size calculations for micro-randomized trials in mHealth. Stat Med. 2016 May 30;35(12):1944-71. doi: 10.1002/sim.6847. Epub 2015 Dec 28.
PubMed 26707831Klasnja P, Smith S, Seewald NJ, Lee A, Hall K, Luers B, Hekler EB, Murphy SA. Efficacy of Contextually Tailored Suggestions for Physical Activity: A Micro-randomized Optimization Trial of HeartSteps. Ann Behav Med. 2019 May 3;53(6):573-582. doi: 10.1093/abm/kay067.
PubMed 30192907
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HeartSteps: a Just-in-Time Adaptive Intervention for Increasing Physical Activity Amongst Sedentary Adults.
- ClinicalTrials.gov ID
- NCT03225521
- Acronym / sponsor ID
- HS / HUM00103127
- 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
- 44 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 18 Jul 2015 (actual)
- Primary completion
- 1 Feb 2016 (actual)
- Study completion
- 1 Feb 2016 (actual)
- First posted
- 21 Jul 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.
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
Physical activity is a key behavioral strategy for prevention of non-communicable diseases such as diabetes and heart disease. Mobile health (mHealth) interventions have shown promise for supporting physical activity adoption and maintenance in ways that are highly acceptable to users, scalable, and cost-efficient. This study examines two intervention strategies-contextually tailored activity suggestions and daily planning of the activity for the next day-that a mobile health intervention can use to encourage physical activity in sedentary adults.
Study participants use HeartSteps, an mHealth physical intervention developed by the research team, in their daily lives for six weeks. Over the course of the study both of the HeartSteps intervention components-contextually-tailored activity suggestions and activity planning-are micro-randomized for each participant on each of the day of the study, in order the effects on physical activity of each component separately and how those effects change over time.
The primary hypothesis for suggestions is that providing a contextually tailored activity suggestion increases participant step count over the subsequent 30 minutes following message delivery.
The first secondary hypothesis for suggestions is that the proximal effect of the contextually tailored activity suggestions on the subsequent 30-minute step count will decrease with duration in the study.
The primary hypothesis for planning is that receiving evening planning will increase step count on the following day.
The primary analyses will use the methods developed in Boruvka et al. (2017). The primary longitudinal outcome for activity suggestions will be the log of the step count in the 30 minutes subsequent to decision points. The log of the step count in the 30 minutes prior to randomization will be included as a control variable. The primary longitudinal outcome for planning will be the square root of the step count on the day following the randomization of planning treatment.
All missing but "available" minute-by-minute step counts from the wrist band will be imputed as 0. See "Allocation" section for the definition of availability. Sensitivity analyses using step counts from the mobile phone (secondary data source) will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant-time point is randomized between intervention or no intervention (delivery of a contextually tailored activity suggestion or no suggestion; planning or no planning)
| Arm | Type | Receives |
|---|---|---|
| HeartSteps intervention | Experimental | Behavioral: HeartSteps: A just-in-time adaptive intervention for increasing physical activity amongst sedentary adults.For activity suggestions, at each available decision time, each participant is randomly assigned to either receive an activity suggestion or not. The randomization probability is 0.6 for receiving a message and 0.4 for not receiving a message. For activity planning, at each decision point, the participant is randomized to either receive evening planning or not at that decision time. The randomization probability for receiving planning is 0.5, and 0.5 for not receiving planning. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- English speakers,
- between 18 and 60 years of age,
- could walk for exercise without discomfort, and
- either had a full-time daytime job or a regular schedule outside the home (e.g., students)
- have a personal phone running Android 5.0 or higher or willing to use a study-provided phone as their primary phone for the duration of the study.
Key exclusion criteria (2 listed)
- Need medical supervision to exercise
- Currently using an activity tracker (e.g., FitBit)
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 |
|---|---|---|
| HeartSteps: A just-in-time adaptive intervention for increasing physical activity amongst sedentary adults.HeartSteps is an Android-based mHealth intervention that contains two main intervention components: contextually-tailored suggestions for activity and planning of the next day's activity. Activity suggestions provide individuals with actionable suggestions for how they can be active in their current context. Delivered suggestions are tailored based on time of day, user's location, day of the week (weekend/weekday), and weather. HeartSteps can deliver a user activity suggestions up to five times a day. Evening planning asks users to create or choose a plan of how they will be active on the following day. Planning can be delivered once a day, in the evening. | Behavioural | HeartSteps intervention |
Primary outcome
30 minute step count
Time frame: 30 minutes
30-minute window after each available decision point
Daily step count
Time frame: 24 hour day
Daily step count on the day following treatment
1 secondary outcome
Thumbs up/down
Time frame: 30-minute window while message is available
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 25 Oct 2018.
- Background: PubMed 30467446Boruvka A, Almirall D, Witkiewitz K, Murphy SA. Assessing Time-Varying Causal Effect Moderation in Mobile Health. J Am Stat Assoc. 2018;113(523):1112-1121. doi: 10.1080/01621459.2017.1305274. Epub 2017 Mar 29.
- Background: PubMed 26651463Klasnja P, Hekler EB, Shiffman S, Boruvka A, Almirall D, Tewari A, Murphy SA. Microrandomized trials: An experimental design for developing just-in-time adaptive interventions. Health Psychol. 2015 Dec;34S(0):1220-8. doi: 10.1037/hea0000305.
- Background: PubMed 26707831Liao P, Klasnja P, Tewari A, Murphy SA. Sample size calculations for micro-randomized trials in mHealth. Stat Med. 2016 May 30;35(12):1944-71. doi: 10.1002/sim.6847. Epub 2015 Dec 28.
- Derived from this study: PubMed 30192907Klasnja P, Smith S, Seewald NJ, Lee A, Hall K, Luers B, Hekler EB, Murphy SA. Efficacy of Contextually Tailored Suggestions for Physical Activity: A Micro-randomized Optimization Trial of HeartSteps. Ann Behav Med. 2019 May 3;53(6):573-582. doi: 10.1093/abm/kay067.
- 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. Predrag Klasnja. 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.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing HeartSteps: A just-in-time adaptive intervention for increasing physical activity amongst sedentary adults. in people with Physical Activity, run by Kaiser Permanente.
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 2 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 25 Oct 2018. 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 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?
On the ClinicalTrials.gov record for NCT03225521, which also lists 4 linked publications.
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 25 Oct 2018.