ExerciseNCT03415542
A Comparison of Exercise Beliefs to Same-day Exercise Behavior
A study testing Exercise Promotion in people with Exercise, run by Brown University at 1 site in United States.
Trial summary
Regular aerobic exercise is associated with reduced risk of multiple cancers, yet the majority of adults are inactive. Across health behavior theories, the expectations people have about the outcomes of exercise influence their decision to exercise. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- Exercise Promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2016to 1 Jan 2019
- 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
- Generally healthy, inactive adults 18-65
Who cannot join
- Chronic diseases, recent hospitalization for mental health problems, binge drinking, physical limitations that would make exercise unsafe
Trial locations and contacts
1 site in 1 country.
About this study
Official title: When Outcomes Matter: A Temporal Analysis of Instrumental and Affective Outcomes of Exercise Behavior Using Ecological Momentary Assessment
Regular aerobic exercise is associated with reduced risk of multiple cancers, yet the majority of adults are inactive. Across health behavior theories, the expectations people have about the outcomes of exercise influence their decision to exercise. Extending prior work, a fine-grained analysis of the relationship between perceived outcomes and daily exercise behavior will be achieved using ecological momentary assessment methods to measure perceived outcomes, and accelerometry to measure exercise objectively. The results of this research will inform exercise promotion efforts by determining how perceptions and temporal factors interact to predict exercise behavior.
Read the detailed description
There is strong evidence for an association between regular physical activity and reduced risk for cancers of the breast and colon. The majority of adults do not engage in enough physical activity. Motivating adults to exercise is critical to cancer prevention efforts. However, additional work is needed to improve the theoretical frameworks applied to exercise promotion. The most often cited theories of health promotion include the outcomes of a target behavior as important determinants. The perceptions people have about the outcomes of exercise, and more generally attitudes about exercise, are associated with exercise participation. Conceptualizations of perceived outcomes are categorized by whether they are instrumental (i.e. utility-based) or affective (i.e. feeling-based) in nature. Recent efforts to compare the relative predictive power of instrumental and affective attitudes suggest that affective attitudes may better predict exercise behavior. Aim 1 of this proposal seeks to compare the relative influence of instrumental versus affective attitudes on exercise behavior. Another distinction can be made between perceptions that are held temporally proximal versus distal to exercise behavior. In the vast majority of relevant research in the exercise field, perceptions are assessed and then future exercise behavior is assessed months later via self-report. However, day to day perceptions and exercise behavior is largely unknown. The temporal distance of perceptions from the decision to exercise can be significantly shortened using ecological momentary assessments. Aim 2 of this proposal seeks to compare the relative predictive power of temporally distal versus proximal perceptions on exercise behavior. Finally, aim 3 will examine the interaction between instrumental/affective and temporally proximal/distal attitudes for predicting exercise behavior. The proposed research seeks to contribute to cancer prevention efforts by examining underlying perceptions that motivate the day to day decision to exercise. In particular, technological advances in mobile platforms to deliver interventions to people wherever they are requires better support for how to apply these methods. Using theory-based, empirically supported concepts, this longitudinal study will follow previously inactive adults over 12 weeks using electronic diaries to measure their perceptions and exercise behavior change while they receive an exercise intervention. This study will provide a fine-grained examination of the determinants of exercise targeted in exercise promotion interventions. The results will inform future efforts to promote exercise using mobile technologies by determining what types of beliefs (instrumental/affective) and what times (temporal proximity to behavior) are most critical times to intervene.
- Conditions
- Exercise
- Being tested
- Exercise Promotion
- Keywords
- Attitudes, Ecological momentary assessment
- Medical subject headings
- Motor Activity, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise PromotionBehavioural
Evidence-based techniques (goal-setting, reduced barriers) for increasing exercise behavior
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Other | Participants receive a print-based exercise promotion program across 12 weeks and are asked to monitor their exercise behavior using an app on their cell phone. Receives: Behavioral: Exercise Promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise behavior
Examine the association between attitudes and exercise behavior defined by the time of the start and end of each exercise session
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start23 May 2016
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by Brown 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica A Emerson, MS, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415542
- Sponsor's protocol ID
- 1604001464
- Status last verified
- Aug 2019
- First submitted
- 6 Dec 2017
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon request, data may be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- When Outcomes Matter: A Temporal Analysis of Instrumental and Affective Outcomes of Exercise Behavior Using Ecological Momentary Assessment
- ClinicalTrials.gov ID
- NCT03415542
- Acronym / sponsor ID
- 1604001464
- Conditions
- Exercise
- Keywords
- Attitudes, Ecological momentary assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- 23 May 2016 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 30 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.
Regular aerobic exercise is associated with reduced risk of multiple cancers, yet the majority of adults are inactive. Across health behavior theories, the expectations people have about the outcomes of exercise influence their decision to exercise. Extending prior work, a fine-grained analysis of the relationship between perceived outcomes and daily exercise behavior will be achieved using ecological momentary assessment methods to measure perceived outcomes, and accelerometry to measure exercise objectively. The results of this research will inform exercise promotion efforts by determining how perceptions and temporal factors interact to predict exercise behavior.
Detailed description
There is strong evidence for an association between regular physical activity and reduced risk for cancers of the breast and colon. The majority of adults do not engage in enough physical activity. Motivating adults to exercise is critical to cancer prevention efforts. However, additional work is needed to improve the theoretical frameworks applied to exercise promotion. The most often cited theories of health promotion include the outcomes of a target behavior as important determinants. The perceptions people have about the outcomes of exercise, and more generally attitudes about exercise, are associated with exercise participation. Conceptualizations of perceived outcomes are categorized by whether they are instrumental (i.e. utility-based) or affective (i.e. feeling-based) in nature. Recent efforts to compare the relative predictive power of instrumental and affective attitudes suggest that affective attitudes may better predict exercise behavior. Aim 1 of this proposal seeks to compare the relative influence of instrumental versus affective attitudes on exercise behavior. Another distinction can be made between perceptions that are held temporally proximal versus distal to exercise behavior. In the vast majority of relevant research in the exercise field, perceptions are assessed and then future exercise behavior is assessed months later via self-report. However, day to day perceptions and exercise behavior is largely unknown. The temporal distance of perceptions from the decision to exercise can be significantly shortened using ecological momentary assessments. Aim 2 of this proposal seeks to compare the relative predictive power of temporally distal versus proximal perceptions on exercise behavior. Finally, aim 3 will examine the interaction between instrumental/affective and temporally proximal/distal attitudes for predicting exercise behavior. The proposed research seeks to contribute to cancer prevention efforts by examining underlying perceptions that motivate the day to day decision to exercise. In particular, technological advances in mobile platforms to deliver interventions to people wherever they are requires better support for how to apply these methods. Using theory-based, empirically supported concepts, this longitudinal study will follow previously inactive adults over 12 weeks using electronic diaries to measure their perceptions and exercise behavior change while they receive an exercise intervention. This study will provide a fine-grained examination of the determinants of exercise targeted in exercise promotion interventions. The results will inform future efforts to promote exercise using mobile technologies by determining what types of beliefs (instrumental/affective) and what times (temporal proximity to behavior) are most critical times to intervene.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Other | Behavioral: Exercise PromotionParticipants receive a print-based exercise promotion program across 12 weeks and are asked to monitor their exercise behavior using an app on their cell phone. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Generally healthy, inactive adults 18-65
Key exclusion criteria (1 listed)
- Chronic diseases, recent hospitalization for mental health problems, binge drinking, physical limitations that would make exercise unsafe
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 |
|---|---|---|
| Exercise PromotionEvidence-based techniques (goal-setting, reduced barriers) for increasing exercise behavior | Behavioural | Exercise Intervention |
Primary outcome
Exercise behavior
Time frame: 1 day
Examine the association between attitudes and exercise behavior defined by the time of the start and end of each exercise session
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 15 Aug 2019.
- Individual participant dataSharing planned: No. Upon request, data may be shared with other researchers
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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.
Jessica A Emerson, MS principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Promotion in people with Exercise, run by Brown 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 15 Aug 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?
Exercise behavior (time frame: 1 day). 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 15 Aug 2019.