Sedentary BehaviorNCT03399916
Ecological Momentary Determinants of Sedentary Behavior
A study testing Prompt sent in people with Sedentary Behavior, run by Arizona State University at 1 site in United States.
Trial summary
A two phase trial to understand the personal, behavioral, environmental, and contextual factors that underpin sedentary behavior and to systematically test a series of contextual prompt characteristics that may lead to subsequent change in sedentary behavior. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior
- What is being tested?
- Prompt sent
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Feb 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Full-time employees
- Males or females
- Ages 18-65
- Sedentary working habits (as indicated by >7 hrs/day of sedentary time at work in the Sedentary Behavior Questionnaire)
- Willing to engage in the study assessment and intervention for 10 weeks.
Who cannot join
- Non-ambulatory, pregnant
- Non-English speaking
- Diagnosis of psychiatric problems or taking psychiatric medications
- Medical history that prohibits prolonged standing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TranSITion: Ecological Momentary Determinants of Sedentary Behavior
A two phase trial to understand the personal, behavioral, environmental, and contextual factors that underpin sedentary behavior and to systematically test a series of contextual prompt characteristics that may lead to subsequent change in sedentary behavior.
Read the detailed description
Phase 1: This is an observational study that will utilized Ecological Momentary Assessment, to determine which personal (e.g. fatigue, mood, and stress level), behavioral (e.g. watching TV, working at desk, and eating meals), environmental (e.g. being at home or work, time of the day, and weather) and contextual factors were associated with sedentary behavior. Three EMAs per day will be sent randomly sent to participants on weekdays (Monday to Friday), for four consecutive weeks (total of 20 days). During these days, participants will also wear an activPAL device to objectively measure sedentary behavior. The purpose of the study is to identify the combination of factors most likely to precede and proceed short (<30 min) and long (≥30 min) bouts of sedentary behavior.
Phase 2: A micro-randomized trial will be used to evaluate the efficacy of an email-based prompt to elicit a proximal effect (e.g., a postural response defined as a transition from seated to standing or seated to moving within 5 minutes to interrupt prolonged sitting) compared to a no prompt condition. A secondary aim of this study is to determine whether prompts that encourage standing are more likely to elicit a response than those that encourage moving. An exploratory aim is to examine whether varying the content of the stand or move prompt to include combinations of short term goals and employer approval, influence the magnitude of response.
- Conditions
- Sedentary Behavior
- Being tested
- Prompt sent
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prompt sentBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Prompt | Experimental | An email based prompt was sent- containing either a stand or move message. Exploratory variations of the prompt were designed to include the addition of a goal e.g., stand for the next 5-minutes, and/or employer support e.g., PTS says "stand for the next 5 minutes". Receives: Behavioral: Prompt sent |
| No Prompt | No intervention | Prompt delivery was sequentially randomized to be sent (ST) or not sent (NST) to all participants (probability of 0.5), at eight decision points per day (between 9am and 5pm), to achieve a total of 3200 randomizations across participants (160 per participant). Therefore 50% of the time, no prompt was sent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minutes of sitting behavior (minutes/8h workday)
Objectively measured minutes of sitting, standardized to an 8h workday.
Measured: 40 days
Minutes of standing behavior (minutes/8h workday)
Objectively measured minutes of standing, standardized to an 8h workday.
Measured: 40 days
Minutes of light-intensity physical activity (minutes/8h workday)
Objectively measured minutes of light-intensity physical activity, standardized to an 8h workday.
Measured: 40 days
Minutes of moderate-vigorous physical activity (minutes/8h workday)
Objectively measured minutes of moderate-vigorous physical activity, standardized to an 8h workday.
Measured: 40 days
Secondary outcomes (1)
Momentary affective state (4-item Likert Scales)
Affective states will be assessed using an ecological momentary survey based on the Positive and Negative Affect Scale (4-point Likert scale ranging from "not at all" to "extremely") (Range: 1-4) questionnaire. The ecological momentary assessment questions were designed to assess a range of contextual information (i.e., current office location, posture, social interaction) and physical and emotional feeling states (i.e., calmness, energy, happiness, stress, sadness, pain level, productivity, and willingness to stand/move). Each of these questions will be evaluated individually andaveraged to evaluate positive (i.e., calmness, energy, happiness) and negative (i.e., sadness and stress) affective states. An open-source app (Personal Analytic Companion App) will be used to deliver EMA questions randomly throughout a participant's workday. This will allow us to measure self-reported levels of positive or negative affect.
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study startOct 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- More trials run by Arizona State 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
- Factorial
- Model description
- PART B: A three-factor design with two-levels yielded eight experimental conditions, half of which encouraged standing more (stand; n prompt types = 80, n total prompts =800) and the other half encouraged moving more (move; n prompt types = 80, n total prompts =800).
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Sports Medicine
- Responsible party
- Principal investigator, Matthew P Buman, PhD, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399916
- Sponsor's protocol ID
- STUDY00004349
- Status last verified
- Oct 2019
- First submitted
- 22 Dec 2017
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TranSITion: Ecological Momentary Determinants of Sedentary Behavior
- ClinicalTrials.gov ID
- NCT03399916
- Acronym / sponsor ID
- STUDY00004349
- Conditions
- Sedentary Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- American College of Sports Medicine
- Study start
- Oct 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 17 Jan 2018 (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.
A two phase trial to understand the personal, behavioral, environmental, and contextual factors that underpin sedentary behavior and to systematically test a series of contextual prompt characteristics that may lead to subsequent change in sedentary behavior.
Detailed description
Phase 1: This is an observational study that will utilized Ecological Momentary Assessment, to determine which personal (e.g. fatigue, mood, and stress level), behavioral (e.g. watching TV, working at desk, and eating meals), environmental (e.g. being at home or work, time of the day, and weather) and contextual factors were associated with sedentary behavior. Three EMAs per day will be sent randomly sent to participants on weekdays (Monday to Friday), for four consecutive weeks (total of 20 days). During these days, participants will also wear an activPAL device to objectively measure sedentary behavior. The purpose of the study is to identify the combination of factors most likely to precede and proceed short (<30 min) and long (≥30 min) bouts of sedentary behavior.
Phase 2: A micro-randomized trial will be used to evaluate the efficacy of an email-based prompt to elicit a proximal effect (e.g., a postural response defined as a transition from seated to standing or seated to moving within 5 minutes to interrupt prolonged sitting) compared to a no prompt condition. A secondary aim of this study is to determine whether prompts that encourage standing are more likely to elicit a response than those that encourage moving. An exploratory aim is to examine whether varying the content of the stand or move prompt to include combinations of short term goals and employer approval, influence the magnitude of response.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- PART B: A three-factor design with two-levels yielded eight experimental conditions, half of which encouraged standing more (stand; n prompt types = 80, n total prompts =800) and the other half encouraged moving more (move; n prompt types = 80, n total prompts =800).
| Arm | Type | Receives |
|---|---|---|
| Prompt | Experimental | Behavioral: Prompt sentAn email based prompt was sent- containing either a stand or move message. Exploratory variations of the prompt were designed to include the addition of a goal e.g., stand for the next 5-minutes, and/or employer support e.g., PTS says "stand for the next 5 minutes". |
| No Prompt | No intervention | –Prompt delivery was sequentially randomized to be sent (ST) or not sent (NST) to all participants (probability of 0.5), at eight decision points per day (between 9am and 5pm), to achieve a total of 3200 randomizations across participants (160 per participant). Therefore 50% of the time, no prompt was sent. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Full-time employees
- Males or females
- Ages 18-65
- Sedentary working habits (as indicated by >7 hrs/day of sedentary time at work in the Sedentary Behavior Questionnaire)
- Willing to engage in the study assessment and intervention for 10 weeks.
Key exclusion criteria (4 listed)
- Non-ambulatory, pregnant
- Non-English speaking
- Diagnosis of psychiatric problems or taking psychiatric medications
- Medical history that prohibits prolonged standing.
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 |
|---|---|---|
| Prompt sent | Behavioural | Prompt |
Primary outcome
Minutes of sitting behavior (minutes/8h workday)
Time frame: 40 days
Objectively measured minutes of sitting, standardized to an 8h workday.
Minutes of standing behavior (minutes/8h workday)
Time frame: 40 days
Objectively measured minutes of standing, standardized to an 8h workday.
Minutes of light-intensity physical activity (minutes/8h workday)
Time frame: 40 days
Objectively measured minutes of light-intensity physical activity, standardized to an 8h workday.
Minutes of moderate-vigorous physical activity (minutes/8h workday)
Time frame: 40 days
Objectively measured minutes of moderate-vigorous physical activity, standardized to an 8h workday.
1 secondary outcome
Momentary affective state (4-item Likert Scales)
Time frame: 20 days
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 31 Oct 2019.
- Individual participant dataSharing planned: No
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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 Prompt sent in people with Sedentary Behavior, run by Arizona State 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 5 inclusion and 4 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 31 Oct 2019. 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?
Minutes of sitting behavior (minutes/8h workday) (time frame: 40 days). The study lists 4 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 31 Oct 2019.