Physical ActivityTAGNCT02560792
Tailored Activity Goals - an Exercise Prescription Study
A study testing Positive Affect Condition and Negative Affect Condition in people with Physical Activity and Affect, run by University of Colorado, Boulder.
Trial summary
The primary goal of this study is to determine experimentally the relationship between affective response to exercise and future exercise behavior. A secondary goal is to examine potential mediators and moderators of this relationship, specifically four variables considered to contribute to the volitional control of… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Affect
- What is being tested?
- Positive Affect Condition and Negative Affect Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Feb 2010
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- eligible participants will be between the ages of 18 and 39 (for men) and 18 and 45 (for women)
- free of overt disease (as cleared by clinical translational research center medical staff)
- free of mental health conditions other than depression and anxiety (by self-report)
- physically capable of engaging in moderate exercise activity (i.e., no injuries or physical impairments)
- willing to receive a "prescription" for exercise intensity, frequency, and duration, and have access to a computer with Internet connectivity in order to complete the online follow-up survey.
Who cannot join
- elite (i.e., paid) athletes or required to participate in aerobic exercise in conjunction with their occupation (e.g., aerobics instructors)
- women must not be pregnant or planning to become pregnant during the study period
- on any medications for which exercise is contraindicated (as cleared by clinical translational research center medical staff)
- smoker
About this study
The primary goal of this study is to determine experimentally the relationship between affective response to exercise and future exercise behavior. A secondary goal is to examine potential mediators and moderators of this relationship, specifically four variables considered to contribute to the volitional control of exercise behavior - planning, attention, resource commitment, and affect regulation. An additional goal is to examine how symptoms of depression might influence the affective response to exercise, and the relationship between affective response to exercise and exercise behavior.
Read the detailed description
The specific aims are as follows:
Aim 1. The first aim is to determine the effectiveness of an experimental manipulation of individuals' affective response to a laboratory-supervised bout of exercise corresponding to a vigorous intensity (just below the ventilatory threshold), compared to a control condition that simply measures individuals' natural affective response to exercise. The investigators will specifically determine the effect of this manipulation on anticipated, experienced and remembered affective response to exercise.
Aim 2. The second aim is to examine individuals' adherence to an exercise prescription over the course of one week that asks them to exercise daily on their own for twenty minutes at the same intensity (as indicated by a heart rate monitor) as the laboratory-supervised exercise session, and to determine whether adherence to this prescription is greater for those who expect exercise to lead to positive affect than those who expect exercise to lead to negative affect, as compared to a control condition.
Aim 3. The third aim is to examine potential mediators and moderators of the relationship between anticipated affect and subsequent exercise behavior, including volitional control of exercise, affect regulation ability, and symptoms of depression.
- Conditions
- Physical Activity, Affect
- Being tested
- Positive Affect Condition, Negative Affect Condition, Control Condition
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Affect ConditionBehavioural
Participants read: "Most people exercising at this intensity say that it feels good, and that it makes them feel energized and more positive, and more relaxed afterwards. Thinking about your exercise prescription, please list the reasons or ways in which you, personally, might expect this exercise to lead to positive feelings, and what specifically about this exercise might make you, personally, feel good."
Negative Affect ConditionBehavioural
Participants read: "Most people exercising at this intensity say that it doesn't feel very good, and that it makes them feel tired and not so positive, and not very relaxed afterwards. Thinking about your exercise prescription, please list the reasons or ways in which you, personally, might expect this exercise to lead to negative feelings, and what specifically about this exercise might make you, personally, feel bad."
Control ConditionBehavioural
Participants receive no information about affective response
| Study group | Role | What they receive |
|---|---|---|
| Positive Affect Condition | Experimental | Participants read that their exercise prescription was a healthy level of intensity for exercise, and then read that most people indicated this level of intensity leads to positive affect. To further encourage participants to think about how the supposed typical affective response might apply to them personally, they were also asked to describe how they thought the exercise might lead to positive feelings. Receives: Behavioral: Positive Affect Condition |
| Negative Affect Condition | Experimental | Participants read that their exercise prescription was a healthy level of intensity for exercise, and then read that most people indicated this level of intensity leads to negative affect. To further encourage participants to think about how the supposed typical affective response might apply to them personally, they were also asked to describe how they thought the exercise might lead to negative feelings. Receives: Behavioral: Negative Affect Condition |
| Control Condition | Experimental | Participants read that their exercise prescription was a healthy level of intensity for exercise - affect was not mentioned. Receives: Behavioral: Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of exercise according to prescription as measured by exercise log
Number of days of prescribed exercise recorded on exercise log
Measured: 7 days
Days of exercise according to prescription as measured by heart rate monitor
Number of days of prescribed exercise recorded by heart rate monitor
Measured: 7 days
Secondary outcomes (3)
Intentions to exercise according to prescription as measured by intention to exercise scale
Self-report survey: intention to exercise scale
Measured: 5 minutes post-intervention
Volitional control of exercise: Planning as measured by exercise planning scale
Self-report survey: exercise planning scale
Measured: 7 days post-intervention
Volitional control of exercise: Commitment as measured by commitment to exercise scale
Self-report survey: commitment to exercise scale
Measured: 7 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startSep 2009
- Primary completionJan 2010
- Study completionFeb 2010
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Bethany Kwan, PhD, Principal investigator, University of Colorado School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560792
- Sponsor's protocol ID
- F31MH079636
- Other IDs
- F31MH079636
- Acronym
- TAG
- Status last verified
- Sep 2015
- First submitted
- 30 Jul 2015
- Last updated
- 25 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Activity Goals - an Exercise Prescription Study
- ClinicalTrials.gov ID
- NCT02560792
- Acronym / sponsor ID
- TAG / F31MH079636
- Conditions
- Physical Activity, Affect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 25 Sep 2015 (estimated)
- 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 primary goal of this study is to determine experimentally the relationship between affective response to exercise and future exercise behavior. A secondary goal is to examine potential mediators and moderators of this relationship, specifically four variables considered to contribute to the volitional control of exercise behavior - planning, attention, resource commitment, and affect regulation. An additional goal is to examine how symptoms of depression might influence the affective response to exercise, and the relationship between affective response to exercise and exercise behavior.
Detailed description
The specific aims are as follows:
Aim 1. The first aim is to determine the effectiveness of an experimental manipulation of individuals' affective response to a laboratory-supervised bout of exercise corresponding to a vigorous intensity (just below the ventilatory threshold), compared to a control condition that simply measures individuals' natural affective response to exercise. The investigators will specifically determine the effect of this manipulation on anticipated, experienced and remembered affective response to exercise.
Aim 2. The second aim is to examine individuals' adherence to an exercise prescription over the course of one week that asks them to exercise daily on their own for twenty minutes at the same intensity (as indicated by a heart rate monitor) as the laboratory-supervised exercise session, and to determine whether adherence to this prescription is greater for those who expect exercise to lead to positive affect than those who expect exercise to lead to negative affect, as compared to a control condition.
Aim 3. The third aim is to examine potential mediators and moderators of the relationship between anticipated affect and subsequent exercise behavior, including volitional control of exercise, affect regulation ability, and symptoms of depression.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Positive Affect Condition | Experimental | Behavioral: Positive Affect ConditionParticipants read that their exercise prescription was a healthy level of intensity for exercise, and then read that most people indicated this level of intensity leads to positive affect. To further encourage participants to think about how the supposed typical affective response might apply to them personally, they were also asked to describe how they thought the exercise might lead to positive feelings. |
| Negative Affect Condition | Experimental | Behavioral: Negative Affect ConditionParticipants read that their exercise prescription was a healthy level of intensity for exercise, and then read that most people indicated this level of intensity leads to negative affect. To further encourage participants to think about how the supposed typical affective response might apply to them personally, they were also asked to describe how they thought the exercise might lead to negative feelings. |
| Control Condition | Experimental | Behavioral: Control ConditionParticipants read that their exercise prescription was a healthy level of intensity for exercise - affect was not mentioned. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- eligible participants will be between the ages of 18 and 39 (for men) and 18 and 45 (for women)
- free of overt disease (as cleared by clinical translational research center medical staff)
- free of mental health conditions other than depression and anxiety (by self-report)
- physically capable of engaging in moderate exercise activity (i.e., no injuries or physical impairments)
- willing to receive a "prescription" for exercise intensity, frequency, and duration, and have access to a computer with Internet connectivity in order to complete the online follow-up survey.
Key exclusion criteria (4 listed)
- elite (i.e., paid) athletes or required to participate in aerobic exercise in conjunction with their occupation (e.g., aerobics instructors)
- women must not be pregnant or planning to become pregnant during the study period
- on any medications for which exercise is contraindicated (as cleared by clinical translational research center medical staff)
- smoker
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 |
|---|---|---|
| Positive Affect ConditionParticipants read: "Most people exercising at this intensity say that it feels good, and that it makes them feel energized and more positive, and more relaxed afterwards. Thinking about your exercise prescription, please list the reasons or ways in which you, personally, might expect this exercise to lead to positive feelings, and what specifically about this exercise might make you, personally, feel good." | Behavioural | Positive Affect Condition |
| Negative Affect ConditionParticipants read: "Most people exercising at this intensity say that it doesn't feel very good, and that it makes them feel tired and not so positive, and not very relaxed afterwards. Thinking about your exercise prescription, please list the reasons or ways in which you, personally, might expect this exercise to lead to negative feelings, and what specifically about this exercise might make you, personally, feel bad." | Behavioural | Negative Affect Condition |
| Control ConditionParticipants receive no information about affective response | Behavioural | Control Condition |
Primary outcome
Days of exercise according to prescription as measured by exercise log
Time frame: 7 days
Number of days of prescribed exercise recorded on exercise log
Days of exercise according to prescription as measured by heart rate monitor
Time frame: 7 days
Number of days of prescribed exercise recorded by heart rate monitor
3 secondary outcomes
Intentions to exercise according to prescription as measured by intention to exercise scale
Time frame: 5 minutes post-intervention
Volitional control of exercise: Planning as measured by exercise planning scale
Time frame: 7 days post-intervention
Volitional control of exercise: Commitment as measured by commitment to exercise scale
Time frame: 7 days post-intervention
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 Sep 2015.
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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.
Bethany Kwan, PhD principal investigator
University of Colorado School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Positive Affect Condition and Negative Affect Condition in people with Physical Activity and Affect, run by University of Colorado, Boulder.
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 25 Sep 2015. 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?
Days of exercise according to prescription as measured by exercise log (time frame: 7 days). 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 25 Sep 2015; AzTrials last refreshed its copy on 6 Nov 2026.