MotivationNCT04505241
Evaluating Mechanisms of Action of Adaptive Goal-Setting for Physical Activity
A study testing Remotely-delivered physical activity promotion in people with Motivation and Physical Activity Promotion, run by Drexel University at 1 site in United States.
Trial summary
Behavior modification programs hold promise for increasing levels of physical activity (PA) for individuals who are insufficiently active. However, existing interventions, which typically prescribe uniform PA goals across participants, are limited by their insensitivity to changing individual needs and circumstances… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Motivation, Physical Activity Promotion, Behavior Change
- What is being tested?
- Remotely-delivered physical activity promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2020to 1 Apr 2021
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18-75 years old
- Reporting a desire to increase physical activity in order to lose weight, prevent weight gain or improve physical health
- Possessing a smartphone that can connect to a WiFi (wireless fidelity) network
- Daily access to a WiFi connection
- Ability to understand and provide informed consent
- Proficiency in speaking, reading, and writing English
- Currently report engaging in insufficient levels of physical activity (<150 minutes/week of moderate-to-vigorous physical activity)
Who cannot join
- Present involvement in another physical activity promotion or a behavioral weight loss program
- Pregnant or planning to become pregnant within the next 6 months (exclude for either)
- Current BMI <18.5 kg/m^2
- Diagnosis of a medical condition that could limit the ability to increase physical activity
- Acute suicide risk (exclude if present in the past 2 weeks or if any attempts were made in past 2 years)
- Current substance use disorder
Show all 10Show fewer
- Current diagnosis of psychosis
- Current diagnosis of bipolar disorder
- Currently meet criteria for loss-of-control eating
- Presence of compensatory behaviors (vomiting, laxatives, diuretics, exercise)
Trial locations and contacts
1 site in 1 country.
About this study
Behavior modification programs hold promise for increasing levels of physical activity (PA) for individuals who are insufficiently active. However, existing interventions, which typically prescribe uniform PA goals across participants, are limited by their insensitivity to changing individual needs and circumstances over time. An alternative approach is to continuously adjust goal difficulty to match fluctuations in individual performance, or adaptive goal-setting (AGS), which evidence suggests may more effective for increasing PA than non-adaptive approaches. Still, no prior studies have examined the psychological mechanisms targeted by AGS, which limits the ability to further refine and disseminate this technique. In this exploratory study, several candidate mechanisms of AGS (expectancy beliefs about goals, perceived value of goals, affective appraisal of goals, implicit attitudes towards exercise) will be examined. Adult participants interested in increasing their level of physical activity (N = 36) will be randomized to receive 6 weeks of either adaptive goal-setting (AGS) or non-adaptive, static goal-setting (SGS) as part of a remote, low-intensity PA intervention. The primary aim of the study will be to evaluate the hypothesis that AGS, as compared to SGS, results in greater increases over time to four hypothesized psychological mechanisms. The secondary aim will be to evaluate whether post-intervention increases to any among these three mechanisms mediate the relationship between intervention type (AGS vs. SGS) and increases to PA over the course of the intervention.
Read the detailed description
Interested participants will schedule and complete a phone screen with a researcher to determine eligibility, and if deemed eligible, will complete an initial hour-long baseline assessment with a member of the study team. The baseline assessment will be conducted over video call using the secure, easy-to-use and HIPAA-compliant Zoom service hosted by Drexel University. During the baseline assessment, the assessor will electronically obtain the participant's informed consent to participate in the study, guide the participant on using a mobile phone application to track their daily steps (Google Fit), verbally provide participants with psychoeducational content on safely increasing their physical activity, and administer a psychological task (Implicit Association Test) as well as questionnaires (Demographics; Physical Activity Enjoyment Scale; Treatment Self-Regulation Questionnaire; Self-Efficacy for Exercise Scale). Immediately following the assessment, participants will be randomized to receive one of two possible remote physical activity interventions: adaptive goal-setting (AGS) or static goal-setting (SGS). Randomization will follow a stratified procedure based on age (cutoff point = 45 years), and permuted block randomization will be used within strata to assign individuals to an intervention condition (AGS or SGS). Both interventions will be preceded by a 10-day baseline "run-in" period during which participants will be asked to record their activity but will not receive any daily step goals. In addition, in both interventions, a brief (10-minute) mid-study (3-week) check-in call will be conducted with each participant by a member of the study team to encourage continued compliance with step goals and problem-solve any barriers to increasing physical activity. Participants will also complete a brief survey once each week over the course of the intervention period. At the conclusion of the intervention period, participants will complete several post-intervention questionnaires/tasks and will then be compensated for their participation.
Participants in the adaptive goal-setting condition will begin receiving a new step goal each day over text message (SMS) following the baseline run-in period (starting Week 2). These messages will continue to be delivered each day for the entire duration of the 6-week intervention period (through Week 8), and will contain information about the participant's daily-assigned step goal as well as their number of steps on the previous day in reference to their previous day's goal. Goals will be calculated using a 60th percentile method (consistent with prior research on adaptive goal-setting), such that each day's goal will be set to the 60th percentile value of the last 9 days of available step data for that participant. Goals will be calculated by an algorithm stored on a remote database that automatically extracts user data from the Google Fit cloud server (Google Fitness Store). The database will store daily steps data for each participant, use these data to calculate new daily step goals and transmit them over SMS using a commercial cloud communications platform. The maximum steps goal permitted by the algorithm will be 20,000 steps/day, to ensure that goals remain within an attainable range for most individuals. Participants in the static goal-setting condition will receive the same exact step goal each day (10,000 steps), consistent with prior research, and will receive daily text message updates providing a summary of their previous day's steps and encouraging them to reach their 10,000-step goal for that day.
- Being tested
- Remotely-delivered physical activity promotion
- Keywords
- Physical Activity, Goal-Setting, Adaptive Interventions, Health-Related Behavior Change
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remotely-delivered physical activity promotionBehavioural
Over video-call, participants will receive educational content on safely increasing their levels of physical activity (e.g., selecting an appropriate form of exercise, minimizing health risks, the importance of planning), will receive daily text messages (see arm descriptions) for six weeks and complete a 10-15 minute check-in call at the 3-week point of the intervention to assess compliance with daily step goals as well as to help problem-solve barriers to compliance.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Goal-Setting | Experimental | Participants in this condition will receive daily step goals calculated as the 60th percentile of their last 9 days of available daily steps data. Goals will be transmitted over text message, and will be accompanied by information about the participant's steps on the previous day and whether they met their goal the previous day. Receives: Behavioral: Remotely-delivered physical activity promotion |
| Static Goal-Setting | Experimental | Participants in this condition will receive daily a uniform daily goal of 10,000 steps per day. Participants will receive daily texts including information about the participant's steps on the previous day, whether they met their goal the previous day, and encouraging them to continue striving for 10,000 steps each day. Receives: Behavioral: Remotely-delivered physical activity promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change to Week 3 Expectancy Beliefs about Goals at Week 7
Expectations about one's own ability to achieve physical activity goals will be assessed weekly using a single Likert scale derived from prior research on Expectancy-Values Theories (EVT) of achievement motivation. Responses on the scale will range from 1-5, with higher values representing higher expectations about one's ability to achieve daily activity goals.
Measured: Measured once weekly from Week 3 through Week 7
Change to Week 3 Affective Appraisals of Goals at Week 7
Appraisals of daily physical activity goals will assessed weekly using a single Likert scale item asking participants to rate their emotional reactions to daily goals on a scale from 1 (Most Negative) to 10 (Most Positive).
Measured: Measured once weekly from Week 3 through Week 7
Change to Week 3 Perceived Value of Goals at Week 7
Perceived Value of Goals corresponds to the value or importance that an individual attributes to assigned activity goals, and will be assessed weekly using four items derived from Expectancy-Value Theory (EVT) questionnaires (attainment value; interest value; utility value; cost). All items will be measured on a 1-5 Likert scale where higher scores represent higher perceived value, and the mean of all four items will be used to generate an overall Perceived Value score.
Measured: Measured once weekly from Week 3 through Week 7
Change to Baseline Implicit Attitudes Towards Exercise at Week 8
Implicit attitudes towards exercise will be measured using an Implicit Association Test (IAT) tailored to examine attitudes towards exercise. Image and text stimuli will be closely adapted from prior IAT research in the domain of exercise, with "Exercise" vs. "Not Exercise" serving as the concept dimension and "Pleasant" vs. "Unpleasant" serving as the attribute dimension. A difference score (d-score) will be computed for each participant, with more positive scores indicating more favorable implicit attitudes towards exercise.
Measured: Measured at Week 0 (baseline) and Week 8 (post-intervention)
Secondary outcomes (4)
Change to Baseline Self-efficacy for Exercise at Week 8
Self-efficacy regarding one's ability to exercise will be examined using the Self-Efficacy for Exercise (SEE) questionnaire. This 9-item questionnaire assesses an individual's confidence in their ability to exercise when faced with a variety of barriers (e.g., fatigue, discomfort, lack of time). Items are rated on a 0-10 scale, with higher scores representing greater self-efficacy about one's ability to exercise. Scores for each item are averaged to compute an overall self-efficacy score.
Measured: Measured at Week 0 (baseline) and Week 8 (post-intervention)
Change to Baseline Physical Activity Enjoyment at Week 8
Enjoyment of physical activity will be assessed using the Physical Activity Enjoyment Scale (PACES) is an 18-item measure that evaluates enjoyment of various facets of physical activity on a 7-point bipolar Likert scale, with higher scores indicating greater enjoyment of exercise. Scores for each item are averaged to compute an overall physical activity enjoyment score.
Measured: Measured at Week 0 (baseline) and Week 8 (post-intervention)
Change to Autonomous Motivation to Exercise at Week 8
Autonomous motivation to exercise will be assessed using the Treatment Self-Regulation Questionnaire (TSRQ), which is a 15-item measure examines several facets of motivation to engage in health behaviors as conceptualized by self-determination theory. Responses are rated on a Likert scale (0 = not at all true, 7 = very true) and averaged across items to compute individual subscale scores (autonomous, external, introjected, identified, amotivation). The current study will focus primarily on the Autonomous Motivation subscale, which assesses an individual's intrinsic reasons for engaging in health behaviors.
Measured: Measured at Week 0 (baseline) and Week 8 (post-intervention)
Change to Baseline Daily Levels of Physical Activity at Week 8
Daily level of physical activity will be measured as the number of steps that a participant records each day using their smartphone pedometers. Daily steps data collected over the full duration intervention phase will be automatically transferred via Google Fit to a remote database where they will be stored and later analyzed.
Measured: Measured at Week 0 (baseline) and Week 8 (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start21 Sep 2020
- Primary completion1 Feb 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MotivationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Half of participants will be randomized to receive text message-delivered adaptive goal-setting (goals change each day) for 6 weeks, and half will receive static goal-setting (goals are fixed) for 6 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evan Forman, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505241
- Sponsor's protocol ID
- DRX-7861
- Status last verified
- Apr 2021
- First submitted
- 2 Aug 2020
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Mechanisms of Action of Adaptive Goal-Setting for Physical Activity
- ClinicalTrials.gov ID
- NCT04505241
- Acronym / sponsor ID
- DRX-7861
- Keywords
- Physical Activity, Goal-Setting, Adaptive Interventions, Health-Related Behavior Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 10 Aug 2020 (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.
Behavior modification programs hold promise for increasing levels of physical activity (PA) for individuals who are insufficiently active. However, existing interventions, which typically prescribe uniform PA goals across participants, are limited by their insensitivity to changing individual needs and circumstances over time. An alternative approach is to continuously adjust goal difficulty to match fluctuations in individual performance, or adaptive goal-setting (AGS), which evidence suggests may more effective for increasing PA than non-adaptive approaches. Still, no prior studies have examined the psychological mechanisms targeted by AGS, which limits the ability to further refine and disseminate this technique. In this exploratory study, several candidate mechanisms of AGS (expectancy beliefs about goals, perceived value of goals, affective appraisal of goals, implicit attitudes towards exercise) will be examined. Adult participants interested in increasing their level of physical activity (N = 36) will be randomized to receive 6 weeks of either adaptive goal-setting (AGS) or non-adaptive, static goal-setting (SGS) as part of a remote, low-intensity PA intervention. The primary aim of the study will be to evaluate the hypothesis that AGS, as compared to SGS, results in greater increases over time to four hypothesized psychological mechanisms. The secondary aim will be to evaluate whether post-intervention increases to any among these three mechanisms mediate the relationship between intervention type (AGS vs. SGS) and increases to PA over the course of the intervention.
Detailed description
Interested participants will schedule and complete a phone screen with a researcher to determine eligibility, and if deemed eligible, will complete an initial hour-long baseline assessment with a member of the study team. The baseline assessment will be conducted over video call using the secure, easy-to-use and HIPAA-compliant Zoom service hosted by Drexel University. During the baseline assessment, the assessor will electronically obtain the participant's informed consent to participate in the study, guide the participant on using a mobile phone application to track their daily steps (Google Fit), verbally provide participants with psychoeducational content on safely increasing their physical activity, and administer a psychological task (Implicit Association Test) as well as questionnaires (Demographics; Physical Activity Enjoyment Scale; Treatment Self-Regulation Questionnaire; Self-Efficacy for Exercise Scale). Immediately following the assessment, participants will be randomized to receive one of two possible remote physical activity interventions: adaptive goal-setting (AGS) or static goal-setting (SGS). Randomization will follow a stratified procedure based on age (cutoff point = 45 years), and permuted block randomization will be used within strata to assign individuals to an intervention condition (AGS or SGS). Both interventions will be preceded by a 10-day baseline "run-in" period during which participants will be asked to record their activity but will not receive any daily step goals. In addition, in both interventions, a brief (10-minute) mid-study (3-week) check-in call will be conducted with each participant by a member of the study team to encourage continued compliance with step goals and problem-solve any barriers to increasing physical activity. Participants will also complete a brief survey once each week over the course of the intervention period. At the conclusion of the intervention period, participants will complete several post-intervention questionnaires/tasks and will then be compensated for their participation.
Participants in the adaptive goal-setting condition will begin receiving a new step goal each day over text message (SMS) following the baseline run-in period (starting Week 2). These messages will continue to be delivered each day for the entire duration of the 6-week intervention period (through Week 8), and will contain information about the participant's daily-assigned step goal as well as their number of steps on the previous day in reference to their previous day's goal. Goals will be calculated using a 60th percentile method (consistent with prior research on adaptive goal-setting), such that each day's goal will be set to the 60th percentile value of the last 9 days of available step data for that participant. Goals will be calculated by an algorithm stored on a remote database that automatically extracts user data from the Google Fit cloud server (Google Fitness Store). The database will store daily steps data for each participant, use these data to calculate new daily step goals and transmit them over SMS using a commercial cloud communications platform. The maximum steps goal permitted by the algorithm will be 20,000 steps/day, to ensure that goals remain within an attainable range for most individuals. Participants in the static goal-setting condition will receive the same exact step goal each day (10,000 steps), consistent with prior research, and will receive daily text message updates providing a summary of their previous day's steps and encouraging them to reach their 10,000-step goal for that day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Half of participants will be randomized to receive text message-delivered adaptive goal-setting (goals change each day) for 6 weeks, and half will receive static goal-setting (goals are fixed) for 6 weeks.
| Arm | Type | Receives |
|---|---|---|
| Adaptive Goal-Setting | Experimental | Behavioral: Remotely-delivered physical activity promotionParticipants in this condition will receive daily step goals calculated as the 60th percentile of their last 9 days of available daily steps data. Goals will be transmitted over text message, and will be accompanied by information about the participant's steps on the previous day and whether they met their goal the previous day. |
| Static Goal-Setting | Experimental | Behavioral: Remotely-delivered physical activity promotionParticipants in this condition will receive daily a uniform daily goal of 10,000 steps per day. Participants will receive daily texts including information about the participant's steps on the previous day, whether they met their goal the previous day, and encouraging them to continue striving for 10,000 steps each day. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18-75 years old
- Reporting a desire to increase physical activity in order to lose weight, prevent weight gain or improve physical health
- Possessing a smartphone that can connect to a WiFi (wireless fidelity) network
- Daily access to a WiFi connection
- Ability to understand and provide informed consent
Key exclusion criteria (10 listed)
- Present involvement in another physical activity promotion or a behavioral weight loss program
- Pregnant or planning to become pregnant within the next 6 months (exclude for either)
- Current BMI <18.5 kg/m^2
- Diagnosis of a medical condition that could limit the ability to increase physical activity
- Acute suicide risk (exclude if present in the past 2 weeks or if any attempts were made in past 2 years)
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 |
|---|---|---|
| Remotely-delivered physical activity promotionOver video-call, participants will receive educational content on safely increasing their levels of physical activity (e.g., selecting an appropriate form of exercise, minimizing health risks, the importance of planning), will receive daily text messages (see arm descriptions) for six weeks and complete a 10-15 minute check-in call at the 3-week point of the intervention to assess compliance with daily step goals as well as to help problem-solve barriers to compliance. | Behavioural | Adaptive Goal-Setting, Static Goal-Setting |
Primary outcome
Change to Week 3 Expectancy Beliefs about Goals at Week 7
Time frame: Measured once weekly from Week 3 through Week 7
Expectations about one's own ability to achieve physical activity goals will be assessed weekly using a single Likert scale derived from prior research on Expectancy-Values Theories (EVT) of achievement motivation. Responses on the scale will range from 1-5, with higher values representing higher expectations about one's ability to achieve daily activity goals.
Change to Week 3 Affective Appraisals of Goals at Week 7
Time frame: Measured once weekly from Week 3 through Week 7
Appraisals of daily physical activity goals will assessed weekly using a single Likert scale item asking participants to rate their emotional reactions to daily goals on a scale from 1 (Most Negative) to 10 (Most Positive).
Change to Week 3 Perceived Value of Goals at Week 7
Time frame: Measured once weekly from Week 3 through Week 7
Perceived Value of Goals corresponds to the value or importance that an individual attributes to assigned activity goals, and will be assessed weekly using four items derived from Expectancy-Value Theory (EVT) questionnaires (attainment value; interest value; utility value; cost). All items will be measured on a 1-5 Likert scale where higher scores represent higher perceived value, and the mean of all four items will be used to generate an overall Perceived Value score.
Change to Baseline Implicit Attitudes Towards Exercise at Week 8
Time frame: Measured at Week 0 (baseline) and Week 8 (post-intervention)
Implicit attitudes towards exercise will be measured using an Implicit Association Test (IAT) tailored to examine attitudes towards exercise. Image and text stimuli will be closely adapted from prior IAT research in the domain of exercise, with "Exercise" vs. "Not Exercise" serving as the concept dimension and "Pleasant" vs. "Unpleasant" serving as the attribute dimension. A difference score (d-score) will be computed for each participant, with more positive scores indicating more favorable implicit attitudes towards exercise.
4 secondary outcomes
Change to Baseline Self-efficacy for Exercise at Week 8
Time frame: Measured at Week 0 (baseline) and Week 8 (post-intervention)
Change to Baseline Physical Activity Enjoyment at Week 8
Time frame: Measured at Week 0 (baseline) and Week 8 (post-intervention)
Change to Autonomous Motivation to Exercise at Week 8
Time frame: Measured at Week 0 (baseline) and Week 8 (post-intervention)
Change to Baseline Daily Levels of Physical Activity at Week 8
Time frame: Measured at Week 0 (baseline) and Week 8 (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 13 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Motivation
Recruiting
Sustainability of the Effects of an Adapted Physical Activity Program on Physical Fitness and Psycho-behavioral Factors in Patients With Chronic Diseases
Adapted Physical Activity, Smartwatches
Not yet recruiting
The Effect of Two Different Generative AI Tools on Nursing Students' Patient Counseling Skills and Motivation Regarding Instructional Materials
Artifical Intelligence, Generative Artificial Intelligence
Recruiting
Behavioural Study in Chronic Pain : Creativity and Motivation, and Circuits Involved in Functional MRI
Chronic Pain
Active, not recruiting
Flipped Classroom vs. Flip-Jigsaw in Theoretical Physiotherapy Education
Physiotherapy and Rehabilitation, Educational Technology
Active, not recruitingPhase 3
PREVENT HPV -Related Cancers Trial
HPV Vaccination, Uptake Vaccination
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 Remotely-delivered physical activity promotion in people with Motivation and Physical Activity Promotion, run by Drexel 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 7 inclusion and 10 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 13 Apr 2021. 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 to Week 3 Expectancy Beliefs about Goals at Week 7 (time frame: Measured once weekly from Week 3 through Week 7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.