Adult DiseaseNCT03119220
Applying a Stress Framework to Health Behavior Change: A Fitbit Study
A study testing Fitbit One in people with Adult Disease, run by Brandeis University.
Trial summary
The current study aims to counteract perceived stress-related barriers to implementation and maintenance of positive health behavior change (i.e., increasing physical activity), by providing an individually tailored and comprehensive informational support program. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Adult Disease
- What is being tested?
- Fitbit One
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 8 May 2015to Jan 2017
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- residents of Waltham and surrounding communities
- between the ages of 50 and 70+
- English and non-English speaking participants
- individuals who are sedentary and/or dealing with health issues and have been unsuccessful in implementing behavior change **We will ask participants three questions that will be rated on a 1 to 10 scale. They will be asked 1) how concerned they are about their current level of exercise, 2) how much pressure they feel to exercise more, and 3) how difficult it feels to overcome obstacles to exercise. To be eligible, participants must rate the first question at a 6 or higher and the three questions together at 15.
Who cannot join
- Participants who have been told not to participate in physical activity or who have doubts about their ability to safely increase physical activity
- not able to walk or not able to walk continuously for several minutes without pain
- being very active and rate the question regarding how much they are in motion during the day at 8 or higher (on a scale of 1-10)
About this study
The current study aims to counteract perceived stress-related barriers to implementation and maintenance of positive health behavior change (i.e., increasing physical activity), by providing an individually tailored and comprehensive informational support program. This translates into an intervention that, in addition to behavior monitoring (low informational support), will provide comprehensive informational support by combining advice and suggestions on how to achieve positive physical activity change with information on the health effects of such a change (high informational support). The latter will be achieved by providing information on general health benefits of increasing physical activity as well as on how physical activity change is linked to individual changes in health-relevant outcomes (i.e., mood and sleep quality changes). Specifically, it is hypothesized that:
- Higher chronic stress levels in general as well as stress perceived by the anticipated task of improving physical activity will be negatively associated with physical activity changes.
- Participants receiving informational support will show decreases in task-related stress.
- Furthermore, participants who receive comprehensive informational support will show larger physical activity improvements than participants who do not receive informational support.
- Initial stress will act as a moderator of the effects of informational support on physical activity, such that higher initial stress will reduce the positive effects of informational support.
Importantly, the proposed intervention is specifically designed to support the subsequent development of an intervention program that is not only feasible, but easy to implement by individuals motivated to achieve a positive health behavior change. A key factor will be the insights gained into stress as a mechanism that counteracts implementation and maintenance of behavior change. This is especially important given the central role of stress in negative health outcomes associated with lack of physical activity, such as poor sleep, negative mood, and chronic low-grade inflammation.
Read the detailed description
Research to date has not fully addressed the role of stress in behavior change. Stress is implicated in many negative health outcomes, including poor sleep, depressive mood, and health problems related to chronic low-grade inflammation, such as hypertension, diabetes, and obesity. These negative health outcomes can lead an individual to form intentions to change health behavior. However, while stress-related negative health outcomes may motivate the attempt to change behavior, the simple intention or very attempt to change behavior may induce stress. Thus, a vicious cycle is started in which stress contributes to health conditions that necessitate and motivate behavior change attempts, while simultaneously immobilizing one from successfully implementing behavior change.
The multiple pathways through which stress can influence health behaviors may become especially apparent in middle-aged and older adults. Not only does poor health increase the urgency for behavior change and thus present a perceived threat, but the lack of resources, such as knowledge of how to implement change, and presence of barriers, such as limited time due to stressful jobs, fear of negative effects, potential to fail, or uncertainty of beneficial outcomes, all contribute to making behavior change a daunting and stressful endeavor. Conversely, many behavior change techniques can be conceptualized as stress management techniques. These techniques can operate by reducing threat perception and/or increasing access to resources, often via provision of informational support.
The proposed study thus seeks to reduce stress in order to facilitate implementation of physical activity change. This will be accomplished by providing health behavior-relevant informational support to sedentary middle-aged and older adults. Specifically, the study's aims are:
- To determine whether providing individually tailored and comprehensive informational support can increase the number of daily steps in middle-aged and older adults in a 12-week physical activity intervention setting.
- To assess how initial stress, initial stress perceived due to the intention to implement behavior change, and changes in perceived stress throughout the intervention affect physical activity change.
- To elucidate downstream effects of the intervention in terms of mental health (i.e., depressive symptoms, chronic stress) and physical health outcomes (i.e., inflammatory status) In line with the Roybal Center Aim 1, the current study explicitly targets a population of sedentary middle-aged and older adults who unsuccessfully attempted to increase physical activity. Pressure to change behavior will in many cases stem from health decrements. Furthermore, participants will be recruited from the Waltham community, which will allow targeted advertisement to ensure a diverse sample in terms of socioeconomic background as well as ethnicity. Lastly, only participants who cannot walk for stretches of several minutes without pain will be excluded, allowing individuals in early stages of disability to participate. Using a stress framework to develop the current intervention and assessing psychological, social, and biological correlates will contribute to Roybal Center Aim 2, as the findings will advance theory and empirical findings on behavior change processes and mechanism. Lastly, the current study addresses Roybal Center Aim 3, as knowledge gained from the current study will facilitate larger-scale physical activity interventions expected to improve health and quality of life of older adults.
- Conditions
- Adult Disease
- Being tested
- Fitbit One
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit OneDevice
Participants will receive a Fitbit device and a detailed user manual as well as diary materials to record daily steps taken, miles walked, and flight of stairs walked for a total of 12 weeks. An in-person follow-up meeting will be scheduled 7 days after the initial meeting to establish the baseline activity level of the participant and to determine the target number of daily steps for the subsequent 5 blocks of 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Low informational support | Other | After the first week, informational support will be manipulated by providing one group with information in the form of physical activity monitoring only. Receives: Device: Fitbit One |
| high informational support | Other | The second group will additionally receive individualized information on how to change behavior by providing maps of a participant's neighborhood with distances depicted in steps, lists with age- and health-status appropriate suggestions as to how to increase numbers of steps, as well as medical information linking changes in physical activity to change in health outcomes; and information on health effects of behavior change by monitoring changes in sleep in conjunction with physical activity changes. Receives: Device: Fitbit One |
What is being measured
The primary outcome is the main question the study is designed to answer.
daily steps
daily physical activity measured in steps taken
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start8 May 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult DiseaseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The overall behavior change goal is defined as increasing physical activity by 15% every other week over 10 weeks based on an initial one week of activity recording establishing an individual's baseline. This will result in a doubling of the initial steps by weeks 10-11, while keeping the demands and goals comparable between individuals. After the first week, informational support will be manipulated by providing one group with information in the form of physical activity monitoring only. The second group will additionally receive individualized information on how to change behavior by providing maps of a participant's neighborhood with distances depicted in steps, lists with age- and health-status appropriate suggestions as to how to increase numbers of steps, as well as medical information linking changes in physical activity to change in health outcomes; and information on health effects of behavior change by monitoring changes in sleep in conjunction with physical activity changes.
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brandeis University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119220
- Sponsor's protocol ID
- 15138
- Other IDs
- P30AG048785
- Status last verified
- Apr 2017
- First submitted
- 13 Apr 2017
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying a Stress Framework to Health Behavior Change: A Fitbit Study
- ClinicalTrials.gov ID
- NCT03119220
- Acronym / sponsor ID
- 15138
- Conditions
- Adult Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Brandeis UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 8 May 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 18 Apr 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 current study aims to counteract perceived stress-related barriers to implementation and maintenance of positive health behavior change (i.e., increasing physical activity), by providing an individually tailored and comprehensive informational support program. This translates into an intervention that, in addition to behavior monitoring (low informational support), will provide comprehensive informational support by combining advice and suggestions on how to achieve positive physical activity change with information on the health effects of such a change (high informational support). The latter will be achieved by providing information on general health benefits of increasing physical activity as well as on how physical activity change is linked to individual changes in health-relevant outcomes (i.e., mood and sleep quality changes). Specifically, it is hypothesized that:
- Higher chronic stress levels in general as well as stress perceived by the anticipated task of improving physical activity will be negatively associated with physical activity changes.
- Participants receiving informational support will show decreases in task-related stress.
- Furthermore, participants who receive comprehensive informational support will show larger physical activity improvements than participants who do not receive informational support.
- Initial stress will act as a moderator of the effects of informational support on physical activity, such that higher initial stress will reduce the positive effects of informational support.
Importantly, the proposed intervention is specifically designed to support the subsequent development of an intervention program that is not only feasible, but easy to implement by individuals motivated to achieve a positive health behavior change. A key factor will be the insights gained into stress as a mechanism that counteracts implementation and maintenance of behavior change. This is especially important given the central role of stress in negative health outcomes associated with lack of physical activity, such as poor sleep, negative mood, and chronic low-grade inflammation.
Detailed description
Research to date has not fully addressed the role of stress in behavior change. Stress is implicated in many negative health outcomes, including poor sleep, depressive mood, and health problems related to chronic low-grade inflammation, such as hypertension, diabetes, and obesity. These negative health outcomes can lead an individual to form intentions to change health behavior. However, while stress-related negative health outcomes may motivate the attempt to change behavior, the simple intention or very attempt to change behavior may induce stress. Thus, a vicious cycle is started in which stress contributes to health conditions that necessitate and motivate behavior change attempts, while simultaneously immobilizing one from successfully implementing behavior change.
The multiple pathways through which stress can influence health behaviors may become especially apparent in middle-aged and older adults. Not only does poor health increase the urgency for behavior change and thus present a perceived threat, but the lack of resources, such as knowledge of how to implement change, and presence of barriers, such as limited time due to stressful jobs, fear of negative effects, potential to fail, or uncertainty of beneficial outcomes, all contribute to making behavior change a daunting and stressful endeavor. Conversely, many behavior change techniques can be conceptualized as stress management techniques. These techniques can operate by reducing threat perception and/or increasing access to resources, often via provision of informational support.
The proposed study thus seeks to reduce stress in order to facilitate implementation of physical activity change. This will be accomplished by providing health behavior-relevant informational support to sedentary middle-aged and older adults. Specifically, the study's aims are:
- To determine whether providing individually tailored and comprehensive informational support can increase the number of daily steps in middle-aged and older adults in a 12-week physical activity intervention setting.
- To assess how initial stress, initial stress perceived due to the intention to implement behavior change, and changes in perceived stress throughout the intervention affect physical activity change.
- To elucidate downstream effects of the intervention in terms of mental health (i.e., depressive symptoms, chronic stress) and physical health outcomes (i.e., inflammatory status) In line with the Roybal Center Aim 1, the current study explicitly targets a population of sedentary middle-aged and older adults who unsuccessfully attempted to increase physical activity. Pressure to change behavior will in many cases stem from health decrements. Furthermore, participants will be recruited from the Waltham community, which will allow targeted advertisement to ensure a diverse sample in terms of socioeconomic background as well as ethnicity. Lastly, only participants who cannot walk for stretches of several minutes without pain will be excluded, allowing individuals in early stages of disability to participate. Using a stress framework to develop the current intervention and assessing psychological, social, and biological correlates will contribute to Roybal Center Aim 2, as the findings will advance theory and empirical findings on behavior change processes and mechanism. Lastly, the current study addresses Roybal Center Aim 3, as knowledge gained from the current study will facilitate larger-scale physical activity interventions expected to improve health and quality of life of older adults.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The overall behavior change goal is defined as increasing physical activity by 15% every other week over 10 weeks based on an initial one week of activity recording establishing an individual's baseline. This will result in a doubling of the initial steps by weeks 10-11, while keeping the demands and goals comparable between individuals. After the first week, informational support will be manipulated by providing one group with information in the form of physical activity monitoring only. The second group will additionally receive individualized information on how to change behavior by providing maps of a participant's neighborhood with distances depicted in steps, lists with age- and health-status appropriate suggestions as to how to increase numbers of steps, as well as medical information linking changes in physical activity to change in health outcomes; and information on health effects of behavior change by monitoring changes in sleep in conjunction with physical activity changes.
| Arm | Type | Receives |
|---|---|---|
| Low informational support | Other | Device: Fitbit OneAfter the first week, informational support will be manipulated by providing one group with information in the form of physical activity monitoring only. |
| high informational support | Other | Device: Fitbit OneThe second group will additionally receive individualized information on how to change behavior by providing maps of a participant's neighborhood with distances depicted in steps, lists with age- and health-status appropriate suggestions as to how to increase numbers of steps, as well as medical information linking changes in physical activity to change in health outcomes; and information on health effects of behavior change by monitoring changes in sleep in conjunction with physical activity changes. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- residents of Waltham and surrounding communities
- between the ages of 50 and 70+
- English and non-English speaking participants
- individuals who are sedentary and/or dealing with health issues and have been unsuccessful in implementing behavior change **We will ask participants three questions that will be rated on a 1 to 10 scale. They will be asked 1) how concerned they are about their current level of exercise, 2) how much pressure they feel to exercise more, and 3) how difficult it feels to overcome obstacles to exercise. To be eligible, participants must rate the first question at a 6 or higher and the three questions together at 15.
Key exclusion criteria (3 listed)
- Participants who have been told not to participate in physical activity or who have doubts about their ability to safely increase physical activity
- not able to walk or not able to walk continuously for several minutes without pain
- being very active and rate the question regarding how much they are in motion during the day at 8 or higher (on a scale of 1-10)
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 |
|---|---|---|
| Fitbit OneParticipants will receive a Fitbit device and a detailed user manual as well as diary materials to record daily steps taken, miles walked, and flight of stairs walked for a total of 12 weeks. An in-person follow-up meeting will be scheduled 7 days after the initial meeting to establish the baseline activity level of the participant and to determine the target number of daily steps for the subsequent 5 blocks of 2 weeks. | Device | Low informational support, high informational support |
Primary outcome
daily steps
Time frame: 12 weeks
daily physical activity measured in steps taken
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 19 Apr 2017.
- Individual participant dataSharing planned: Yes
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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 Fitbit One in people with Adult Disease, run by Brandeis University.
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 3 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 19 Apr 2017. 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?
daily steps (time frame: 12 weeks). 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 19 Apr 2017.