Physical InactivityNCT05930431
Physical Activity Variety's Impact on Physical Activity Participation
A study testing Physical activity variety intervention and Physical activity consistency comparison condition in people with Physical Inactivity, run by University of Minnesota at 1 site in United States.
Trial summary
The primary purpose of the proposed study is to examine the effect of a home-based physical activity variety intervention on objectively measured physical activity in an eight-week randomized intervention trial. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- Physical activity variety intervention and Physical activity consistency comparison condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 3 Jun 2024
- 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 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Engaged in no or low levels of physical activity (less than 90 minutes of moderate to vigorous intensity physical activity per week)
- Capable of completing a 30-minute session of physical activity
- 18-25 years of age old
Who cannot join
- Pregnant individuals
- Cannot read in English
- No access to the internet
- Healthcare providers have instructed them not to be active
- Any medical condition that would make physical activity unsafe or unwise
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
The primary purpose of the proposed study is to examine the effect of a home-based physical activity variety intervention on objectively measured physical activity in an eight-week randomized intervention trial.
Read the detailed description
The primary purpose of the proposed study is to examine the effect of a home-based physical activity variety intervention on objectively measured physical activity in an eight-week randomized intervention trial. Early research on physical activity variety has observed increased physical activity participation, motivation, and enjoyment as a result of physical activity variety. However, previous studies examining variety have not included home-based interventions, objective measures of physical activity, or cardiovascular fitness classes.
Forty low-active college students will be randomly assigned to either an eight-week physical activity variety intervention (n=20) or a physical activity consistency comparison condition (n=20). Physical activity will be assessed via an accelerometer (e.g., Actigraph) at baseline and eight weeks, and psychosocial variables at baseline, four weeks, and eight weeks (i.e., post-intervention). Affect will be assessed at one, four, and eight weeks. Participants will receive counseling sessions and access to a website containing workouts appropriate to their condition.
- Conditions
- Physical Inactivity
- Being tested
- Physical activity variety intervention, Physical activity consistency comparison condition
- Keywords
- variety, consistency, HIIT (High intensity interval training), intervention, physical activity participation, enjoyment, motivation
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity variety interventionBehavioural
The counseling in the variety condition will serve many purposes. The first session will concentrate on informing participants on the importance of having variety in their physical activity routine and how to access the variety of physical activities available to them. The variety condition will be instructed to complete at least three different HIIT workouts per week. They will be encouraged to complete more than three workouts. The following counseling sessions will be provided to not only continue supporting variety in physical activity but also to support participants' basic psychological needs.
Physical activity consistency comparison conditionBehavioural
The counseling in the consistency condition will serve many purposes. The first session will concentrate on informing participants the importance of having consistency in their physical activity routine and how to access the HIIT workout available to them. The consistency condition will be instructed to complete the provided HIIT workout three times per week. They will be encouraged to complete more than three workouts. The following counseling sessions will be provided to not only continue supporting consistency in physical activity but also to support participants' basic psychological needs.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity variety intervention | Experimental | Participants in the variety condition will be sent the link to their condition's website via email. The variety website will contain nine distinct high intensity interval training (HIIT) videos. The videos will be 30-minutes containing a five-minute warm-up, 20-minute workout, and a five-minute cool down. The website will emphasize the importance of having variety in one's physical activity routine. This will include reminders to have variety in selected workouts and the benefits associated with doing so. This emphasis will be supported through the counseling sessions provided to participants in the variety condition. Receives: Behavioral: Physical activity variety intervention |
| Physical activity consistency comparison condition | Active comparator | Upon the completion of randomization, participants in the consistency condition will be sent the link to their condition's website via email. The consistency website will contain one HIIT video. The video will be 30-minutes and include a five-minute warm-up, 20-minute workout, and a five-minute cool down. The website will emphasize the importance of having consistency in one's physical activity routine. This will include reminders to be consistent in workouts and the benefits associated with doing so (Guiney \& Machado, 2013). This emphasis will be supported through the counseling sessions provided to participants in the consistency condition. Receives: Behavioral: Physical activity consistency comparison condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actigraph
An electronic device worn on the right hip to identify motion.
Measured: Measuring the change from baseline to week 8.
Actigraph
An electronic device worn on the right hip to identify steps taken.
Measured: Measuring the change from baseline to week 8.
Actigraph
An electronic device worn on the right hip to identify energy expenditure.
Measured: Measuring the change from baseline to week 8.
Actigraph
An electronic device worn on the right hip to identify time spent in different intensities of activity.
Measured: Measuring the change from baseline to week 8.
7-Day Physical Activity Recall Interview
Allows for tracking all bouts of MVPA that are at least 10 minutes in duration over the previous week. Physical activity is reported as minutes spent in moderate, hard, and very hard activities.
Measured: Measuring change weekly from baseline until the eighth week of the intervention.
Secondary outcomes (7)
Behavioral Regulation in Exercise Questionnaire (BREQ-2)
Questionnaire: The BREQ-2 will assess participants' motivation regarding physical activity including amotivation, external regulation, introjected regulation, identified regulation, intrinsic regulation, and intrinsic motivation towards physical activity. The BREQ-2 is 19 items that includes a five-point Likert scale ranging from 0-4 with zero indicating "is not true" and four "very true." The BREQ-2 is a validated and commonly used measure examining SDT constructs.
Measured: At baseline, weeks 4, and 8.
Motives for Physical Activity Measure-Revised (MPAM-R)
Questionnaire: The MPAM-R will be administered to assess participants' motives for physical activity. The five areas of motivation that are assessed include the following: Interest/enjoyment, competence, appearance, fitness, and social. Participants indicate how true an item is regarding why they engage in physical activity. Examples of the 30 items include, "It is fun," "I want to maintain physical strength for a healthy life," and "I like to be with others interested in this activity." The MPAM-R includes a Likert scale ranging from 1-7, with one indicating "not at all true" and a seven "very true." This measure has been validated for measuring motives for physical activity.
Measured: At baseline, weeks 4, and 8.
Psychological Need Satisfaction in Exercise (PNSE)
Questionnaire: The PNSE will assess participants' satisfaction of their psychological needs, competence, autonomy, and relatedness. This measure is 18-items with six items examining each psychological need. An example of one item included for perceived competence is, "I feel that I am able to complete exercises that are personally challenging." An example of one item for perceived autonomy is, "I feel free to exercise in my own way." Lastly, one example of an item included for perceived relatedness is, "I feel attached to my exercise companions because they accept me for who I am." The items are scored using a Likert scale ranging from 1-6 with a one indicating "false" and a six representing "true." Higher values signify greater satisfaction of psychological needs. The PNSE has high reliability and is a commonly used measure for basic psychological needs.
Measured: At baseline, weeks 4, and 8.
Physical Activity Enjoyment Scale (PACES)
Questionnaire: The PACES will assess participants' physical activity enjoyment. The PACES is an 18-item measure instructing participants to, "Measure how they feel about physical activity at this moment in time...." Participants rate each item using a Likert scale ranging from 1-7 with one and seven reflecting opposite ends of the spectrum. For example, the two anchors for the first item are, "I enjoy it" and "I hate it." In this example, a one aligns with "I enjoy it" and a seven aligns with "I hate it." Eleven of the items are reverse scored. Higher scores indicate higher levels of physical activity enjoyment. This measure has been found to be reliable and valid.
Measured: At baseline, weeks 4, and 8.
Bored of Sports Scale (BOSS)
Questionnaire: The BOSS is a newly developed scale to assess boredom in physical activity. The BOSS is 11 items and includes a five-point Likert scale ranging from 0-4, with one representing "strongly disagree" and four representing "strongly agree." An example of an item is, "Exercising is dull and monotonous." Participants respond to prompts regarding their boredom in a specific bout of physical activity. This measure has been found to be reliable.
Measured: At baseline, weeks 4, and 8.
Exercise-Induced Feeling Inventory (EFI)
Questionnaire: The EFI will assess exercise feeling. The 12-item questionnaire instructs participants to, "Indicate how each word describes how they feel at this moment in time...." Participants rate how they feel on a Likert scale of 0-4 with a zero indicating an item is "not felt;" whereas, a four indicates an item is "felt very strongly." Examples of the items are "refreshed," "worn out," and "energetic." The EFI is scored by summing the four subscales, which include revitalization, physical exhaustion, positive engagement, and tranquility. The four subscales each consist of three items. The EFI has demonstrated good internal consistency and reliability.
Measured: At baseline, weeks 4, and 8.
Feeling Scale (FS)
Questionnaire: The FS will assess affective valence experienced during physical activity. The FS is a two-item questionnaire that measures how participants are feeling and how much they are enjoying or enjoyed exercise. Participants rate their current feeling before, during, and after physical activity as part of the FS-current using a scale of -5 to +5, with a higher score indicating higher levels of positive affect. They rate their enjoyment as part of the FS-enjoyment on a scale of 1-7, with higher scores reflecting higher enjoyment. The FS is reliable for assessing in-exercise affect.
Measured: At weeks 1, 4, and 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 Sep 2023
- Primary completion3 Jun 2024
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two distinct physical activity groups occurring at the same time.
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930431
- Sponsor's protocol ID
- U_of_Minnesota_PA_Variety
- Status last verified
- Jan 2025
- First submitted
- 12 May 2023
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Principal Investigator will be the only person with the authority to release the collected data. Confidential information will not be released under any circumstance. The original data file will stay in its original slate.
Publications
Glaros, N. M., & Janelle, C. M. (2001). Varying the mode of cardiovascular exercise to increase adherence. Journal of Sport Behavior, 24(1).
Juvancic-Heltzel JA, Glickman EL, Barkley JE. The effect of variety on physical activity: a cross-sectional study. J Strength Cond Res. 2013 Jan;27(1):244-51. doi: 10.1519/JSC.0b013e3182518010.
PubMed 22395266Sylvester BD, Standage M, McEwan D, Wolf SA, Lubans DR, Eather N, Kaulius M, Ruissen GR, Crocker PR, Zumbo BD, Beauchamp MR. Variety support and exercise adherence behavior: experimental and mediating effects. J Behav Med. 2016 Apr;39(2):214-24. doi: 10.1007/s10865-015-9688-4. Epub 2015 Nov 6.
PubMed 26546241
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Variety's Impact on Physical Activity Participation
- ClinicalTrials.gov ID
- NCT05930431
- Acronym / sponsor ID
- U_of_Minnesota_PA_Variety
- Conditions
- Physical Inactivity
- Keywords
- variety, consistency, HIIT (High intensity interval training), intervention, physical activity participation, enjoyment, motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 5 Jul 2023 (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 primary purpose of the proposed study is to examine the effect of a home-based physical activity variety intervention on objectively measured physical activity in an eight-week randomized intervention trial.
Detailed description
The primary purpose of the proposed study is to examine the effect of a home-based physical activity variety intervention on objectively measured physical activity in an eight-week randomized intervention trial. Early research on physical activity variety has observed increased physical activity participation, motivation, and enjoyment as a result of physical activity variety. However, previous studies examining variety have not included home-based interventions, objective measures of physical activity, or cardiovascular fitness classes.
Forty low-active college students will be randomly assigned to either an eight-week physical activity variety intervention (n=20) or a physical activity consistency comparison condition (n=20). Physical activity will be assessed via an accelerometer (e.g., Actigraph) at baseline and eight weeks, and psychosocial variables at baseline, four weeks, and eight weeks (i.e., post-intervention). Affect will be assessed at one, four, and eight weeks. Participants will receive counseling sessions and access to a website containing workouts appropriate to their condition.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two distinct physical activity groups occurring at the same time.
| Arm | Type | Receives |
|---|---|---|
| Physical activity variety intervention | Experimental | Behavioral: Physical activity variety interventionParticipants in the variety condition will be sent the link to their condition's website via email. The variety website will contain nine distinct high intensity interval training (HIIT) videos. The videos will be 30-minutes containing a five-minute warm-up, 20-minute workout, and a five-minute cool down. The website will emphasize the importance of having variety in one's physical activity routine. This will include reminders to have variety in selected workouts and the benefits associated with doing so. This emphasis will be supported through the counseling sessions provided to participants in the variety condition. |
| Physical activity consistency comparison condition | Active comparator | Behavioral: Physical activity consistency comparison conditionUpon the completion of randomization, participants in the consistency condition will be sent the link to their condition's website via email. The consistency website will contain one HIIT video. The video will be 30-minutes and include a five-minute warm-up, 20-minute workout, and a five-minute cool down. The website will emphasize the importance of having consistency in one's physical activity routine. This will include reminders to be consistent in workouts and the benefits associated with doing so (Guiney \& Machado, 2013). This emphasis will be supported through the counseling sessions provided to participants in the consistency condition. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Engaged in no or low levels of physical activity (less than 90 minutes of moderate to vigorous intensity physical activity per week)
- Capable of completing a 30-minute session of physical activity
- 18-25 years of age old
Key exclusion criteria (5 listed)
- Pregnant individuals
- Cannot read in English
- No access to the internet
- Healthcare providers have instructed them not to be active
- Any medical condition that would make physical activity unsafe or unwise
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 |
|---|---|---|
| Physical activity variety interventionThe counseling in the variety condition will serve many purposes. The first session will concentrate on informing participants on the importance of having variety in their physical activity routine and how to access the variety of physical activities available to them. The variety condition will be instructed to complete at least three different HIIT workouts per week. They will be encouraged to complete more than three workouts. The following counseling sessions will be provided to not only continue supporting variety in physical activity but also to support participants' basic psychological needs. | Behavioural | Physical activity variety intervention |
| Physical activity consistency comparison conditionThe counseling in the consistency condition will serve many purposes. The first session will concentrate on informing participants the importance of having consistency in their physical activity routine and how to access the HIIT workout available to them. The consistency condition will be instructed to complete the provided HIIT workout three times per week. They will be encouraged to complete more than three workouts. The following counseling sessions will be provided to not only continue supporting consistency in physical activity but also to support participants' basic psychological needs. | Behavioural | Physical activity consistency comparison condition |
Primary outcome
Actigraph
Time frame: Measuring the change from baseline to week 8.
An electronic device worn on the right hip to identify motion.
Actigraph
Time frame: Measuring the change from baseline to week 8.
An electronic device worn on the right hip to identify steps taken.
Actigraph
Time frame: Measuring the change from baseline to week 8.
An electronic device worn on the right hip to identify energy expenditure.
Actigraph
Time frame: Measuring the change from baseline to week 8.
An electronic device worn on the right hip to identify time spent in different intensities of activity.
7-Day Physical Activity Recall Interview
Time frame: Measuring change weekly from baseline until the eighth week of the intervention.
Allows for tracking all bouts of MVPA that are at least 10 minutes in duration over the previous week. Physical activity is reported as minutes spent in moderate, hard, and very hard activities.
7 secondary outcomes
Behavioral Regulation in Exercise Questionnaire (BREQ-2)
Time frame: At baseline, weeks 4, and 8.
Motives for Physical Activity Measure-Revised (MPAM-R)
Time frame: At baseline, weeks 4, and 8.
Psychological Need Satisfaction in Exercise (PNSE)
Time frame: At baseline, weeks 4, and 8.
Physical Activity Enjoyment Scale (PACES)
Time frame: At baseline, weeks 4, and 8.
Bored of Sports Scale (BOSS)
Time frame: At baseline, weeks 4, and 8.
Exercise-Induced Feeling Inventory (EFI)
Time frame: At baseline, weeks 4, and 8.
Feeling Scale (FS)
Time frame: At weeks 1, 4, and 8.
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 7 Jan 2025.
- BackgroundGlaros, N. M., & Janelle, C. M. (2001). Varying the mode of cardiovascular exercise to increase adherence. Journal of Sport Behavior, 24(1).
- Background: PubMed 22395266Juvancic-Heltzel JA, Glickman EL, Barkley JE. The effect of variety on physical activity: a cross-sectional study. J Strength Cond Res. 2013 Jan;27(1):244-51. doi: 10.1519/JSC.0b013e3182518010.
- Background: PubMed 26546241Sylvester BD, Standage M, McEwan D, Wolf SA, Lubans DR, Eather N, Kaulius M, Ruissen GR, Crocker PR, Zumbo BD, Beauchamp MR. Variety support and exercise adherence behavior: experimental and mediating effects. J Behav Med. 2016 Apr;39(2):214-24. doi: 10.1007/s10865-015-9688-4. Epub 2015 Nov 6.
- Individual participant dataSharing planned: No. The Principal Investigator will be the only person with the authority to release the collected data. Confidential information will not be released under any circumstance. The original data file will stay in its original slate.
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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 Physical activity variety intervention and Physical activity consistency comparison condition in people with Physical Inactivity, run by University of Minnesota 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 3 inclusion and 5 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 7 Jan 2025. 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?
Actigraph (time frame: Measuring the change from baseline to week 8.). The study lists 5 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 NCT05930431, which also lists 3 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 7 Jan 2025.