Physical ActivityNCT03906955
A Video Chat Intervention for Enhancing Self-efficacy for Lifestyle Physical Activity
A study testing Efficacy for Lifestyle PA and Efficacy for Work-life Balance in people with Physical Activity and Self Efficacy, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of three, brief (10-minute) theory-guided video chats for increasing self-efficacy for lifestyle physical activity versus a time-matched video chat comparison group designed to increase self-efficacy for work-life balance. Read more about this study
- Who is it for?
- Ages 25 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Self Efficacy, Working Adults
- What is being tested?
- Efficacy for Lifestyle PA and Efficacy for Work-life Balance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2019to 15 Sep 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 25 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 25-64 years of age
- inactive (defined as not participating in exercise for 2 or more days per week for >30 minutes over the past 3-months)
- willing to be randomized to any condition
- owns iOs or Android smartphone
Who cannot join
- unable to speak or read English
- having a cognitive impairment (assessed via modified Telephone Interview for Cognitive Status [TICS]; score less than 21 will result in study exclusion)
- unable to exercise at moderate intensity level without causing or exacerbating a pre-existing condition which prevents participation in an exercise program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing a Brief, Theory-guided Video Chat Intervention for Enhancing Self-efficacy and Lifestyle Physical Activity Among Low Active Working Adults
The purpose of this study is to evaluate the efficacy of three, brief (10-minute) theory-guided video chats for increasing self-efficacy for lifestyle physical activity versus a time-matched video chat comparison group designed to increase self-efficacy for work-life balance. Participants will include individuals who are low-active, full-time (>35 hours/week) working adults.
Read the detailed description
Eligible participants will complete three brief (10-minute) video chats to promote self-efficacy during the first three weeks of engaging in lifestyle physical activity. Randomization will place participants into one of two groups: (1) Social Cognitive Theory-guided video chat or (2) time-matched video chat comparison group. Video chats will be delivered via the Google Duo smartphone app.
Baseline and follow-up assessments will consist of psycho-social questionnaires assessing constructs of the Social Cognitive Theory, affect, stress, and work-life balance. Physiological measures including heart rate will be assessed during a baseline treadmill assessment (to be completed in lab). All participants, regardless of group, will be asked to wear an activity tracker for the entirety of the study for assessing lifestyle physical activity. The comparison group will be asked to complete all baseline and follow-up assessments but will not receive information relative to lifestyle physical activity. The baseline assessments will take place with an academic research laboratory and weeks 2-7 will take place off outside of the lab.
- Conditions
- Physical Activity, Self Efficacy, Working Adults
- Being tested
- Efficacy for Lifestyle PA, Efficacy for Work-life Balance
- Keywords
- leisure-time physical activity, adherence, working adults, motivation, social cognitive theory, telemedicine, teleconference, self-perceptions, self-confidence
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efficacy for Lifestyle PABehavioural
Also called intervention group
The intervention group is asked to participate in three (10-minute) video chats during the first three weeks of six weeks of engaging in lifestyle physical activity. Participants in this group will receive information that addresses outcome expectations in week one (e.g. physical, social, and self-evaluative outcomes and intrinsic and extrinsic motives), self-efficacy in week two (e.g. the four efficacy sources: vicarious experiences, mastery experiences, social persuasion, and perceptions of physiological and affective responses to behavior), and self-regulatory strategies in week three (e.g. goal-setting, self-monitoring, and planning) for engaging in lifestyle physical activity.
Efficacy for Work-life BalanceBehavioural
Also called time-matched control group
The time-matched control group is asked to participate in three (10-minute) video chats during the first three weeks of six weeks of engaging in lifestyle physical activity. Participants in this group will receive information that addresses outcome expectations in week one (e.g. physical, social, and self-evaluative outcomes and intrinsic and extrinsic motives), self-efficacy in week two (e.g. the four efficacy sources: vicarious experiences, mastery experiences, social persuasion, and perceptions of physiological and affective responses to behavior), and self-regulatory strategies in week three (e.g. goal-setting, self-monitoring, and planning) for work-life balance.
| Study group | Role | What they receive |
|---|---|---|
| Efficacy for Lifestyle PA | Experimental | Three brief (10-minute) video chats during first three weeks of six weeks of lifestyle physical activity engagement providing information relative to outcome expectations (week 1), self-efficacy (week 2), and self-regulatory strategies (week 3) to enhance self-efficacy for lifestyle physical activity. Receives: Behavioral: Efficacy for Lifestyle PA |
| Efficacy for Work-life Balance | Active comparator | Three brief (10-minute) video chats during first three weeks of six weeks of lifestyle physical activity engagement providing information relative to outcome expectations (week 1), self-efficacy (week 2), and self-regulatory strategies (week 3) to enhance self-efficacy for work-life balance. Receives: Behavioral: Efficacy for Work-life Balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-efficacy for Lifestyle Physical Activity (SELPA)
The SELPA is a 6-item questionnaire that assesses beliefs in one's ability to engage in physical activity of one's own choosing to meet the physical activity guidelines. The SELPA is a modified version of the Lifestyle Efficacy Scale (McAuley, Hall, Motl, Wojcicki, White, Hu, \& Doerksen, 2009). In this study, participants are asked to assess their confidence in their ability to accumulate five or more times per week at a moderate intensity, for at least 30 minutes for six weeks. Each question is based on a confidence scale ranging from 0% (not confident at all) to 100% (highly confident). The SELPA composite score is calculated by summing and averaging the six items, with higher scores representing greater self-efficacy for lifestyle physical activity.
Measured: Assessed at baseline, at week 2, 3, and 4, as well as end of study (beginning of week 8)
Secondary outcomes (15)
Lifestyle Physical Activity (subjective)
Lifestyle physical activity will be assessed via the Godin Leisure-Time Exercise Questionnaire (GLTEQ; Godin \& Shephard, 1985), a brief, 4-item measure of physical activity that asks individuals to assess their current frequencies of engaging in strenuous, moderate, and light activities for at least 15 minutes per session during a typical week.Total weekly leisure activity is calculated by the equation: (9*strenuous) + (5*moderate) + (3*light). The second question assesses the frequency of weekly leisure-time activities that are done long enough for the individual to "work up a sweat."
Measured: Assessed at baseline and at 6-week follow-up
Lifestyle Physical Activity (objective)
Lifestyle physical activity will be objectively measured using the Fitbit Charge 3 activity and sleep tracker. The Fitbit Charge 3 is a small device that measures all-day activity, distance, floors climbed, and sleep. The participants will be asked to wear the device for seven consecutive days (24 hours/day) prior to the brief in-person assessment and upon completion of the in-person assessment, all participants will be asked to wear the device for the entirety of the six weeks of the study period. Lifestyle physical activity will be assessed through "active minutes," or time spent in moderate-intensity activity.
Measured: Assessed for entirety of 7-week study
Positive and Negative Feeling States
The Feeling Scale (FS; Hardy \& Rejeski, 1989), consists of a single-item assessing feelings of pleasure-displeasure, ranging from -5 (very bad) to +5 (very good). Participants are asked how the exercise makes them feel. The FS is scored based upon the number provided by the participant, with a possible range of -5 to +5, with higher scores indicating greater feelings experienced.
Measured: Assessed at week 1 (pre/post-treadmill assessment)
Anticipated Negative Affect
Anticipated negative emotions will be assessed via the Anticipated Negative Affect Questionnaire (ANAQ; Wang, 2011). The ANAQ asks participants to anticipate how they may feel not regularly participating in physical activity. The ANAQ consists of 5 bi-polar items: "relaxed/tense," "not guilty/guilty," "no regret/regret," "not angry/angry," and "displeased/pleased." The ANAQ scale ranges from 1 to 7. Anticipated negative affect is scored based upon the number provided for each individual question, with higher scores indicating more negative emotions.
Measured: Assessed at week 1 (pre/post-treadmill assessment)
Forecasted Pleasure
Forecasted pleasure will be assessed via one question "If you repeated the exercise session again, how do you think it would make you feel?" (Zenko et al., 2016). Responses are recorded by selecting from 15 empirically spaced anchors, ranging from -100 (most unpleasant imaginable) to +100 (most pleasant imaginable). Forecasted pleasure is scored based upon the number provided by the participant, with a possible range of -100 to +100, with higher scores indicating more pleasant, imaginable feelings.
Measured: Assessed at week 1 (pre/post-treadmill assessment)
Sedentary Behavior
The Sedentary Behavior Questionnaire (SBQ; Rosenberg et al., 2010) will be used to assess individual's self-reported sedentary behavior. The SBQ assesses the amount of time spent doing nine sedentary behaviors (watching television, playing computer/video games, sitting while listening to music, sitting and talking on the phone, doing paperwork or office work, sitting and reading, playing a musical instrument, doing arts and crafts, sitting and driving/riding in a car, bus, or train). The SBQ assesses sedentary time on a typical weekday and weekend day. Total sedentary behavior is calculated by recoding time reported into hours, then summing the total hours for all nine measures, for the weekday and weekend day. Weekly estimates are calculated by multiplying the weekday hours by (5) and the weekend day hours by (2), and summing together for total sedentary hours per week.
Measured: Assessed at baseline and at 6-week follow-up
General Stress
General stress will be assessed via the Perceived Stress Scale (PSS; Cohen, Kamarck, \& Mermelstein, 1983). The PSS is a 10-item questionnaire and scores are obtained by reverse scoring on four positive items and then summing across all items. Each question is based on a 5-point Likert scale, ranging from 0 (never) to 4 (very often). Higher scores indicates higher levels of general stress.
Measured: Assessed at baseline and at 6-week follow-up
Job-related Stress
Job stress will be assessed via the Brief Job Stress Questionnaire (BJSQ; Kawada \& Otsuka, 2011). The BJSQ is a 15-item scale that has 4 subscales: evaluation of job demand, job control, support, and degree of job satisfaction. Each question is based on a 4-point Likert scale, ranging from 1 (disagree) to 4 (agree). Each subscale is scored by summing the total items (reverse scoring the job demand subscale), with higher scores being indicative of lower job stress.
Measured: Assessed at baseline and at 6-week follow-up
Exercise Planning and Scheduling
The Exercise Planning and Schedule Scale (EPSS; Rovniak, Anderson, Winett, \& Stephens, 2002) is a 10-item questionnaire that assesses exercise scheduling and planning. Each question is based on a 5-point Likert scale, ranging from 1 (does not describe me) to 5 (describes me completely). The EPSS composite score is calculated by reverse-scoring items 2, 3, and 7 then summing and averaging the 10-items to create a composite score. Higher scores indicate more scheduling and planning done for exercise.
Measured: Assessed at baseline and at 6-week follow-up
Physical Activity Self-regulation
The Physical Activity Self-regulation Scale (PASR-12; Umstattd et al., 2009) assesses the degree to which self-regulation strategies are used to support physical activity behavior. The PASR-12 is a 12-item questionnaire and the composite score is calculated by summing the 12-items. There are six subscales within the PASR-12 (calculated by summing the designated items): self-monitoring, goal-setting, social support, reinforcement, time management, and relapse prevention. Higher scores indicate greater strategy-use (either by subscale or composite score of total strategies used).
Measured: Assessed at baseline and at 6-week follow-up
Self-efficacy to Regulate Work and Life
The Self-efficacy to Regulate Work and Life Questionnaire is a 5-item questionnaire that assesses how confident individuals are in regulating their work and non-work domains (Chan et al., 2016).The five items include: 1) "How confident are you in changing your lifestyle to achieve a good work-life balance?," 2) "How confident are you in finding out how to balance work and life?," 3) "How confident are you in achieving your ideal work-life balance?," 4) "How confident are you in implementing strategies to achieve work-life balance?," and 5) "How confident are you in inventing ways to balance your work and life?." Responses to all items are based on a scale ranging from 0 (cannot do at all) to 100 (highly certain can do). The composite score is calculated by summing and averaging the five items, with higher scores indicating that individuals are more confident in their abilities to cope with work-life challenges.
Measured: Assessed at baseline, at week 2, 3, and 4, as well as end of study (beginning of week 8)
Outcome Expectancies for Exercise
The Multidimensional Outcome Expectancies for Exercise Scale (MOEES; Wójcicki, White, \& McAuley, 2009) is a 15-item questionnaire that has three subscales: physical outcome expectancies, social outcome expectancies, and self-evaluative outcome expectancies. The MOEES assesses an individual's beliefs or expectations about the benefits of regular exercise. Each question is based on a 5-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree). Each subscale is scored by summing the total items, with higher scores being indicative of higher outcome expectations for exercise.
Measured: Assessed at baseline and at 6-week follow-up
Work-life Balance
The work-life balance scale (WLB-6; Gröpel \& Kuhl, 2009) is a 6-item questionnaire that measures perceived sufficiency of time available for work and social life. Each question is based on a 6-point Likert scale, ranging from 1 (completely disagree) to 6 (completely agree). The WLB-6 is scored by reverse coding select items and summing the total items, with higher scores being indicative of high work-life balance.
Measured: Assessed at baseline and at 6-week follow-up
Exercise Self-Schema
The Exercise Self-Schema Questionnaire (ESSQ; Kendzierski, 1988) was originally a 9-item scale. We are using a modified version which includes an additional item reflecting self-certainty ratings for each self-description item, as well as an extra question reflecting self-description, -importance, and -certainty with regard to "I am someone who will always be an exerciser" (Mullen, 2011). This version is a 12-item questionnaire and each question is based on an 11-point Likert Scale, ranging from 1 (does not describe me) to 11 (describes me). The ESSQ will be scored by summing and averaging the subscales (self-description, importance, certainty), with higher scores indicating greater exercise schema. Schematics can also be determined by categorizing responses to self-description and importance items that fall within the 8 to 11 range. In this study, change in self-schema will be assessed via changes in mean levels of the continuous variables rather than the dichotomous categorization.
Measured: Assessed at baseline and at 6-week follow-up
Self-efficacy for Physical Activity
The Sources of Self-efficacy for Physical Activity (Warner et al., 2014) is an 18-item questionnaire that measures mastery experience, self-persuasion, verbal persuasion, vicarious experience, negative affect, and positive affect relative to physical activity. Each question is based on a 4-point Likert Scale, ranging from 1 (strongly disagree) to 4 (strongly agree). The questionnaire is scored by summing and averaging the subscales, with higher scores indicating greater use of self-efficacy sources.
Measured: Assessed at baseline and at 6-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start9 Apr 2019
- Primary completion15 Sep 2019
- Study completion15 Sep 2019
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to one of two groups.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean Mullen, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906955
- Sponsor's protocol ID
- 19544
- Status last verified
- Oct 2019
- First submitted
- 4 Apr 2019
- Last updated
- 24 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Brief, Theory-guided Video Chat Intervention for Enhancing Self-efficacy and Lifestyle Physical Activity Among Low Active Working Adults
- ClinicalTrials.gov ID
- NCT03906955
- Acronym / sponsor ID
- 19544
- Conditions
- Physical Activity, Self Efficacy, Working Adults
- Keywords
- leisure-time physical activity, adherence, working adults, motivation, social cognitive theory, telemedicine, teleconference, self-perceptions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 8 Apr 2019 (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 purpose of this study is to evaluate the efficacy of three, brief (10-minute) theory-guided video chats for increasing self-efficacy for lifestyle physical activity versus a time-matched video chat comparison group designed to increase self-efficacy for work-life balance. Participants will include individuals who are low-active, full-time (>35 hours/week) working adults.
Detailed description
Eligible participants will complete three brief (10-minute) video chats to promote self-efficacy during the first three weeks of engaging in lifestyle physical activity. Randomization will place participants into one of two groups: (1) Social Cognitive Theory-guided video chat or (2) time-matched video chat comparison group. Video chats will be delivered via the Google Duo smartphone app.
Baseline and follow-up assessments will consist of psycho-social questionnaires assessing constructs of the Social Cognitive Theory, affect, stress, and work-life balance. Physiological measures including heart rate will be assessed during a baseline treadmill assessment (to be completed in lab). All participants, regardless of group, will be asked to wear an activity tracker for the entirety of the study for assessing lifestyle physical activity. The comparison group will be asked to complete all baseline and follow-up assessments but will not receive information relative to lifestyle physical activity. The baseline assessments will take place with an academic research laboratory and weeks 2-7 will take place off outside of the lab.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to one of two groups.
| Arm | Type | Receives |
|---|---|---|
| Efficacy for Lifestyle PA | Experimental | Behavioral: Efficacy for Lifestyle PAThree brief (10-minute) video chats during first three weeks of six weeks of lifestyle physical activity engagement providing information relative to outcome expectations (week 1), self-efficacy (week 2), and self-regulatory strategies (week 3) to enhance self-efficacy for lifestyle physical activity. |
| Efficacy for Work-life Balance | Active comparator | Behavioral: Efficacy for Work-life BalanceThree brief (10-minute) video chats during first three weeks of six weeks of lifestyle physical activity engagement providing information relative to outcome expectations (week 1), self-efficacy (week 2), and self-regulatory strategies (week 3) to enhance self-efficacy for work-life balance. |
Who may qualify
- Ages
- 25 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 25-64 years of age
- inactive (defined as not participating in exercise for 2 or more days per week for >30 minutes over the past 3-months)
- willing to be randomized to any condition
- owns iOs or Android smartphone
Key exclusion criteria (3 listed)
- unable to speak or read English
- having a cognitive impairment (assessed via modified Telephone Interview for Cognitive Status [TICS]; score less than 21 will result in study exclusion)
- unable to exercise at moderate intensity level without causing or exacerbating a pre-existing condition which prevents participation in an exercise program
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 |
|---|---|---|
| Efficacy for Lifestyle PAAlso: intervention groupThe intervention group is asked to participate in three (10-minute) video chats during the first three weeks of six weeks of engaging in lifestyle physical activity. Participants in this group will receive information that addresses outcome expectations in week one (e.g. physical, social, and self-evaluative outcomes and intrinsic and extrinsic motives), self-efficacy in week two (e.g. the four efficacy sources: vicarious experiences, mastery experiences, social persuasion, and perceptions of physiological and affective responses to behavior), and self-regulatory strategies in week three (e.g. goal-setting, self-monitoring, and planning) for engaging in lifestyle physical activity. | Behavioural | Efficacy for Lifestyle PA |
| Efficacy for Work-life BalanceAlso: time-matched control groupThe time-matched control group is asked to participate in three (10-minute) video chats during the first three weeks of six weeks of engaging in lifestyle physical activity. Participants in this group will receive information that addresses outcome expectations in week one (e.g. physical, social, and self-evaluative outcomes and intrinsic and extrinsic motives), self-efficacy in week two (e.g. the four efficacy sources: vicarious experiences, mastery experiences, social persuasion, and perceptions of physiological and affective responses to behavior), and self-regulatory strategies in week three (e.g. goal-setting, self-monitoring, and planning) for work-life balance. | Behavioural | Efficacy for Work-life Balance |
Primary outcome
Change in Self-efficacy for Lifestyle Physical Activity (SELPA)
Time frame: Assessed at baseline, at week 2, 3, and 4, as well as end of study (beginning of week 8)
The SELPA is a 6-item questionnaire that assesses beliefs in one's ability to engage in physical activity of one's own choosing to meet the physical activity guidelines. The SELPA is a modified version of the Lifestyle Efficacy Scale (McAuley, Hall, Motl, Wojcicki, White, Hu, \& Doerksen, 2009). In this study, participants are asked to assess their confidence in their ability to accumulate five or more times per week at a moderate intensity, for at least 30 minutes for six weeks. Each question is based on a confidence scale ranging from 0% (not confident at all) to 100% (highly confident). The SELPA composite score is calculated by summing and averaging the six items, with higher scores representing greater self-efficacy for lifestyle physical activity.
15 secondary outcomes
Lifestyle Physical Activity (subjective)
Time frame: Assessed at baseline and at 6-week follow-up
Lifestyle Physical Activity (objective)
Time frame: Assessed for entirety of 7-week study
Positive and Negative Feeling States
Time frame: Assessed at week 1 (pre/post-treadmill assessment)
Anticipated Negative Affect
Time frame: Assessed at week 1 (pre/post-treadmill assessment)
Forecasted Pleasure
Time frame: Assessed at week 1 (pre/post-treadmill assessment)
Sedentary Behavior
Time frame: Assessed at baseline and at 6-week follow-up
General Stress
Time frame: Assessed at baseline and at 6-week follow-up
Job-related Stress
Time frame: Assessed at baseline and at 6-week follow-up
Exercise Planning and Scheduling
Time frame: Assessed at baseline and at 6-week follow-up
Physical Activity Self-regulation
Time frame: Assessed at baseline and at 6-week follow-up
Self-efficacy to Regulate Work and Life
Time frame: Assessed at baseline, at week 2, 3, and 4, as well as end of study (beginning of week 8)
Outcome Expectancies for Exercise
Time frame: Assessed at baseline and at 6-week follow-up
Work-life Balance
Time frame: Assessed at baseline and at 6-week follow-up
Exercise Self-Schema
Time frame: Assessed at baseline and at 6-week follow-up
Self-efficacy for Physical Activity
Time frame: Assessed at baseline and at 6-week follow-up
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 24 Oct 2019.
- Exercise, Technology, and Cognition LaboratoryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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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 Efficacy for Lifestyle PA and Efficacy for Work-life Balance in people with Physical Activity and Self Efficacy, run by University of Illinois at Urbana-Champaign 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 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 24 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?
Change in Self-efficacy for Lifestyle Physical Activity (SELPA) (time frame: Assessed at baseline, at week 2, 3, and 4, as well as end of study (beginning of week 8)). 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 24 Oct 2019.