Sedentary BehaviorNCT04053686
An Intervention to Reduce Prolonged Sitting in Police Staff
A study testing Breaks in people with Sedentary Behavior and Metabolic Syndrome, run by University of Bedfordshire at 1 site in United Kingdom.
Trial summary
The primary aim of this study is to assess the feasibility of an intervention to reduce and break up prolonged sitting time in full-time police staff. The secondary aims of this study are to assess preliminary effects on patterns of sedentary behaviour (number of breaks, number of prolonged sitting bouts, average… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior, Metabolic Syndrome, Affect
- What is being tested?
- Breaks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Sep 2019to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 0.6 Full Time Equivalent (FTE) work hours
- Ambulatory
- Predominantly desk-based (spend on average ≥ 5-h/day seated at work by self-report)
- Own a smartphone, with ability to keep phone with them during work hours
Who cannot join
- Planned absence of two weeks or more during the intervention period
- Work part time (< 0.6 FTE)
- Health contraindications to standing and walking
- Planned relocation to another site, office or workplace
- Have personal access to an active workstation (sit-stand desk, seat cycle, treadmill desk or similar)
- Participating simultaneously in another workplace intervention (for sedentary behaviour, physical activity, diet, lifestyle, or combination thereof)
- Health contraindications to postural stability testing (e.g., injury to the lower extremities in the past six months, dizziness, or epilepsy)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Bedfordfordshire
Bedford, Bedfordshire, MK41 9EA
About this study
Official title: A-REST (Activity to Reduce Excessive Sitting Time): a Cluster Randomised Controlled Feasibility Trial to Reduce Prolonged Sitting in Police Staff
The primary aim of this study is to assess the feasibility of an intervention to reduce and break up prolonged sitting time in full-time police staff. The secondary aims of this study are to assess preliminary effects on patterns of sedentary behaviour (number of breaks, number of prolonged sitting bouts, average duration of prolonged sitting bouts, and total prolonged sitting duration), additional measures of sedentary behaviour (total sitting time, standing, and stepping), cardiometabolic risk markers, physiological stress (cortisol levels), physical health (self-report and postural stability), psychological wellbeing and mood, work stress (self-reported), and work performance (job satisfaction and productivity).
Read the detailed description
Prolonged sedentary behaviour is associated with a higher incidence of cardiovascular disease and type 2 diabetes. A large proportion of daily sedentary time (sitting) occurs in the workplace. On average, full time office workers spend upwards of 70% of their working day seated with the majority of this time accumulated in sitting bouts ≥ 20 minutes. A recent cross-sectional investigation into the occupational characteristics of over 5,000 British police force employees reported at least 30% identifying as having mainly office-based duties. When trying to reduce prolonged sitting in the workplace, one of the most effective strategies is the use of multi-component interventions. At the present time, sedentary workplace intervention studies in the police are limited.
The primary aim of this study is to assess the feasibility of an intervention to reduce and break up prolonged sitting time at work in full-time police staff. The secondary aims of this study are to assess preliminary effects on sedentary behaviour, cardiometabolic risk markers, physiological stress, physical health, psychological wellbeing and mood, work stress, and work performance.
This has a single-arm, pre-post study design. Participants will receive a multi-component intervention to break up and reduce prolonged sitting including: a presentation/workshop, electronic support, minor environmental modifications, organisational support, and team competition. Assessments will take place at baseline and post-intervention (week 10).
- Conditions
- Sedentary Behavior, Metabolic Syndrome, Affect, Stress, Physiological, Stress, Psychological, Musculoskeletal Pain
- Being tested
- Breaks
- Medical subject headings
- Sedentary Behavior, Metabolic Syndrome, Stress, Psychological, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreaksBehavioural
3-min breaks every half hour at work
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group will aim to regularly break up participants' prolonged sitting time with three-minute incidental movement breaks every half hour at work. Support for behaviour change will include a lecture/workshop, electronic prompts, break logging, team competition, health champions, and email support. Receives: Behavioral: Breaks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Adherence: Drop-out rates in control and intervention group
Analyses of drop-out rates (%) in control and intervention group.
Measured: From recruitment (typically 4 weeks prior to baseline) up to study completion (typically 12 weeks)
Feasibility - Acceptability: Perceptions of the intervention
Asking participants' to qualitatively reflect on the intervention via semi-structured interview.
Measured: At week 11
Secondary outcomes (30)
Change in the number of breaks (sit-stand transitions) from sedentary time per hour (workplace and daily)
Participants will wear a thigh-based accelerometer/inclinometer (ActivPAL3), which provides a well established measure of sit-stand transitions.
Measured: This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
Change in sitting time accrued in prolonged bouts (≥ 30 minutes) (workplace and daily)
Participants will wear a thigh-based accelerometer/inclinometer (ActivPAL3), which provides a well established measure of sitting time accrued in prolonged bouts (≥ 30 minutes).
Measured: This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
Change in the average duration (minutes) of prolonged sitting bouts (≥ 30 minutes) (workplace and daily)
Participants will wear a thigh-based accelerometer/inclinometer (ActivPAL3), which provides a well established measure of the average duration (minutes) of prolonged sitting bouts (≥ 30 minutes).
Measured: This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
Change in the number of prolonged sitting bouts (≥ 30 minutes) (workplace and daily)
Participants will wear a thigh-based accelerometer/inclinometer (ActivPAL3), which provides a well established measure of the number of prolonged sitting bouts (≥ 30 minutes).
Measured: This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
Change in the total duration (minutes) of sitting time (workplace and daily)
Participants will wear a thigh-based accelerometer/inclinometer (ActivPAL3), which provides a well established measure of sitting time.
Measured: This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
Change in step count (workplace and daily)
Participants will wear a thigh-based accelerometer/inclinometer (ActivPAL3), which provides a well established measure of step count.
Measured: This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
Change in total stepping time (in minutes) (workplace and daily)
Participants will wear a thigh-based accelerometer/inclinometer (ActivPAL3), which provides a well established measure of total stepping time (in minutes).
Measured: This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
Change in total standing time (in minutes) (workplace and daily)
Participants will wear a thigh-based accelerometer/inclinometer (ActivPAL3), which provides a well established measure of total standing time (in minutes).
Measured: This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
Weight (kg)
Changes in weight via Tanita scale.
Measured: Baseline and at week 11
Body mass index (BMI)
Changes in BMI will be computed by dividing participants' weight (in kilograms) by their height (in metres) squared.
Measured: Baseline and at week 11
Waist circumference (cm)
Changes in waist circumference will be assessed by tape measure.
Measured: Baseline and at week 11
Body fat %
Changes in body fat percentage will be assessed via a bioelectric impedance spectroscopy device.
Measured: Baseline and at week 11
Body fat mass (kg)
Changes in body fat mass via a bioelectric impedance spectroscopy device.
Measured: Baseline and at week 11
Lean body mass (kg)
Changes in lean body mass via a bioelectric impedance spectroscopy device.
Measured: Baseline and at week 11
Blood pressure (mmHg)
Changes in blood pressure measured via electronic sphygmomanometer.
Measured: Baseline and at week 11
Fasted blood cholesterol (mg/dL)
Changes in total, high density lipoprotein (HDL), and low density lipoprotein (LDL) cholesterol measured via fasting blood tests using a Cholestech machine.
Measured: Baseline and at week 11
Fasted blood triglycerides (mg/dL)
Changes in triglycerides measured via fasting blood tests using a Cholestech machine.
Measured: Baseline and at week 11
Fasted blood glucose (mg/dL)
Changes in glucose levels measured via fasting blood tests using a Cholestech machine.
Measured: Baseline and at week 11
Salivary cortisol (nmol/L)
Changes in the cortisol awakening response and diurnal cortisol levels will be assessed via saliva samples (provided by chewing on a cotton swab for 60secs) collected seven times over the course of one day.
Measured: Baseline and at week 11. At each time point saliva samples will be collected at 7 time points over the course of one day.
Nordic musculoskeletal questionnaire
The Nordic musculoskeletal questionnaire is comprised of 40 forced-choice questions pertaining to low back, neck, shoulder and general physical complaints most often experienced in the work setting. A visual diagram aids the viewer by labelling the nine regions of the body referred to in the questionnaire. Acceptable reliability for this tool has been demonstrated.
Measured: Baseline and at week 11
Postural sway velocity (mm/s)
Change in postural sway velocity (bipedal-eyes-open, bipedal-eyes-closed, unipedal-eyes-open, unipedal-eyes-closed) will be evaluated via dynamic plantar pressure sensor (RS Footscan).
Measured: Baseline and at week 11
Postural sway range (mm)
Change in postural sway range (bipedal-eyes-open, bipedal-eyes-closed, unipedal-eyes-open, unipedal-eyes-closed) will be evaluated via dynamic plantar pressure sensor (RS Footscan).
Measured: Baseline and at week 11
International Physical Activity Questionnaire short form (IPAQ)
Changes in self-reported physical activity and total sitting time. The International Physical Activity Questionnaire short form (IPAQ) measures self-reported physical activity and sitting time in the last seven days. Participants are asked to report frequency of participation (0-7 days) and duration of activity on one of those days (in hours and minutes). The IPAQ has demonstrated acceptable reliability and validity in measuring activity in the last seven days.
Measured: Baseline and at week 11
Marshall sitting questionnaire
The Marshall sitting questionnaire has five questions that measure self-reported domain-specific sitting time (hours and minutes) on weekend days and weekdays. This questionnaire has good reliability and validity for sitting time on weekdays and weekend days.
Measured: Baseline and at week 11
Warwick-Edinburgh mental well-being scale (WEMWBS)
The Warwick-Edinburgh mental well-being scale (WEMWBS) is a 14-item questionnaire used to assess various aspects of positive mental health (e.g., "I've been feeling optimistic about the future"). Participants are asked to rate their experience of each wellbeing statement between 1 and 5 (1 = none of the time and 5 = all of the time). Item scores are then combined to provide a total score (between 14 - 70). The higher the score the better the overall mental wellbeing. For intervention purposes, a change in the total score of 3-8 points between two time points may be considered a "meaningful change".
Measured: Baseline and at week 11
Positive and negative affect schedule (PANAS)
Changes in self-reported mood via the positive and negative affect schedule (PANAS) consisting of two 10-item subscales to measure positive and negative affect (i.e., mood). A number of words that describe different feelings and emotions (e.g., "interested", "distressed", "excited") are presented and participants are asked to indicate on a 5-point scale to what extent over the past week they have felt these feelings/emotions (1 = very slightly or not at all and 5 = extremely). These scales are internally consistent with very good convergent and discriminant correlations.
Negative Affect subscale Item scores on the negative affect scale are then combined to provide a total score (between 10 - 50). The higher the score the more negative emotions experienced.
Positive Affect subscale Item scores on the positive affect scale are then combined to provide a total score (between 10 - 50). The higher the score the more positive emotions experienced.
Measured: Baseline and at week 11
Operational police stress questionnaire (PSQ-Op)
Changes in ratings of 20 operational stressors for police (PSQ-Org). Participants will be asked to rate items on "how much stress it has caused you over the past 6 months" using a 7-point Likert scale (1 = no stress at all and 7 = a lot of stress). Item scores are then combined to provide a total score (between 20 - 140). The higher the score the worse the stress level. This instrument has demonstrated acceptable reliability and validity for measuring police-specific occupational stressors.
Measured: Baseline and at week 11
Organisational police stress questionnaire (PSQ-Org)
Changes in ratings of 20 organisational stressors for police (PSQ-Org). Participants will be asked to rate items on "how much stress it has caused you over the past 6 months" using a 7-point Likert scale (1 = no stress at all and 7 = a lot of stress). Item scores are then combined to provide a total score (between 20 - 140). The higher the score the worse the stress level. This instrument has demonstrated acceptable reliability and validity for measuring police-specific occupational stressors.
Measured: Baseline and at week 11
Job satisfaction
Changes in self-reported job satisfaction and will be evaluated via a single-item questionnaire ("How satisfied are you with your job in general?") assessed on a 7-point Likert scale (1 = dissatisfied and 7 = extremely satisfied). A higher score represents more satisfaction with one's job.
Measured: Baseline and at week 11
Job performance
Changes in self-reported job performance will be evaluated via a single-item questionnaire ("How well do you think you have performed in your job recently?") with a 7-point Likert scale (1 = very poorly and 7 = extremely well). A higher score represents a more positive assessment of job performance.
Measured: Baseline and at week 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start9 Sep 2019
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bedfordshire
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marsha Brierley, University of Bedfordshire
- Investigators
- Daniel Bailey, PhD, Principal investigator, University of Bedfordshire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053686
- Sponsor's protocol ID
- 2019ISPAR008
- Status last verified
- Nov 2020
- First submitted
- 29 Jul 2019
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A-REST (Activity to Reduce Excessive Sitting Time): a Cluster Randomised Controlled Feasibility Trial to Reduce Prolonged Sitting in Police Staff
- ClinicalTrials.gov ID
- NCT04053686
- Acronym / sponsor ID
- 2019ISPAR008
- Conditions
- Sedentary Behavior, Metabolic Syndrome, Affect, Stress, Physiological, Stress, Psychological, Musculoskeletal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of BedfordshireUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 12 Aug 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 primary aim of this study is to assess the feasibility of an intervention to reduce and break up prolonged sitting time in full-time police staff. The secondary aims of this study are to assess preliminary effects on patterns of sedentary behaviour (number of breaks, number of prolonged sitting bouts, average duration of prolonged sitting bouts, and total prolonged sitting duration), additional measures of sedentary behaviour (total sitting time, standing, and stepping), cardiometabolic risk markers, physiological stress (cortisol levels), physical health (self-report and postural stability), psychological wellbeing and mood, work stress (self-reported), and work performance (job satisfaction and productivity).
Detailed description
Prolonged sedentary behaviour is associated with a higher incidence of cardiovascular disease and type 2 diabetes. A large proportion of daily sedentary time (sitting) occurs in the workplace. On average, full time office workers spend upwards of 70% of their working day seated with the majority of this time accumulated in sitting bouts ≥ 20 minutes. A recent cross-sectional investigation into the occupational characteristics of over 5,000 British police force employees reported at least 30% identifying as having mainly office-based duties. When trying to reduce prolonged sitting in the workplace, one of the most effective strategies is the use of multi-component interventions. At the present time, sedentary workplace intervention studies in the police are limited.
The primary aim of this study is to assess the feasibility of an intervention to reduce and break up prolonged sitting time at work in full-time police staff. The secondary aims of this study are to assess preliminary effects on sedentary behaviour, cardiometabolic risk markers, physiological stress, physical health, psychological wellbeing and mood, work stress, and work performance.
This has a single-arm, pre-post study design. Participants will receive a multi-component intervention to break up and reduce prolonged sitting including: a presentation/workshop, electronic support, minor environmental modifications, organisational support, and team competition. Assessments will take place at baseline and post-intervention (week 10).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: BreaksThe intervention group will aim to regularly break up participants' prolonged sitting time with three-minute incidental movement breaks every half hour at work. Support for behaviour change will include a lecture/workshop, electronic prompts, break logging, team competition, health champions, and email support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 0.6 Full Time Equivalent (FTE) work hours
- Ambulatory
- Predominantly desk-based (spend on average ≥ 5-h/day seated at work by self-report)
- Own a smartphone, with ability to keep phone with them during work hours
Key exclusion criteria (7 listed)
- Planned absence of two weeks or more during the intervention period
- Work part time (< 0.6 FTE)
- Health contraindications to standing and walking
- Planned relocation to another site, office or workplace
- Have personal access to an active workstation (sit-stand desk, seat cycle, treadmill desk or similar)
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 |
|---|---|---|
| Breaks3-min breaks every half hour at work | Behavioural | Intervention |
Primary outcome
Feasibility - Adherence: Drop-out rates in control and intervention group
Time frame: From recruitment (typically 4 weeks prior to baseline) up to study completion (typically 12 weeks)
Analyses of drop-out rates (%) in control and intervention group.
Feasibility - Acceptability: Perceptions of the intervention
Time frame: At week 11
Asking participants' to qualitatively reflect on the intervention via semi-structured interview.
30 secondary outcomes
Change in the number of breaks (sit-stand transitions) from sedentary time per hour (workplace and daily)
Time frame: This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
Change in sitting time accrued in prolonged bouts (≥ 30 minutes) (workplace and daily)
Time frame: This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
Change in the average duration (minutes) of prolonged sitting bouts (≥ 30 minutes) (workplace and daily)
Time frame: This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
Change in the number of prolonged sitting bouts (≥ 30 minutes) (workplace and daily)
Time frame: This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
Change in the total duration (minutes) of sitting time (workplace and daily)
Time frame: This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
Change in step count (workplace and daily)
Time frame: This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
Change in total stepping time (in minutes) (workplace and daily)
Time frame: This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
Change in total standing time (in minutes) (workplace and daily)
Time frame: This measure will be assessed at baseline and 10 weeks. At each time point the accelerometer will be worn for 7 days.
Weight (kg)
Time frame: Baseline and at week 11
Body mass index (BMI)
Time frame: Baseline and at week 11
Waist circumference (cm)
Time frame: Baseline and at week 11
Body fat %
Time frame: Baseline and at week 11
Body fat mass (kg)
Time frame: Baseline and at week 11
Lean body mass (kg)
Time frame: Baseline and at week 11
Blood pressure (mmHg)
Time frame: Baseline and at week 11
Fasted blood cholesterol (mg/dL)
Time frame: Baseline and at week 11
Fasted blood triglycerides (mg/dL)
Time frame: Baseline and at week 11
Fasted blood glucose (mg/dL)
Time frame: Baseline and at week 11
Salivary cortisol (nmol/L)
Time frame: Baseline and at week 11. At each time point saliva samples will be collected at 7 time points over the course of one day.
Nordic musculoskeletal questionnaire
Time frame: Baseline and at week 11
Postural sway velocity (mm/s)
Time frame: Baseline and at week 11
Postural sway range (mm)
Time frame: Baseline and at week 11
International Physical Activity Questionnaire short form (IPAQ)
Time frame: Baseline and at week 11
Marshall sitting questionnaire
Time frame: Baseline and at week 11
Warwick-Edinburgh mental well-being scale (WEMWBS)
Time frame: Baseline and at week 11
Positive and negative affect schedule (PANAS)
Time frame: Baseline and at week 11
Operational police stress questionnaire (PSQ-Op)
Time frame: Baseline and at week 11
Organisational police stress questionnaire (PSQ-Org)
Time frame: Baseline and at week 11
Job satisfaction
Time frame: Baseline and at week 11
Job performance
Time frame: Baseline and at week 11
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 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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.
Daniel Bailey, PhD principal investigator
University of Bedfordshire
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breaks in people with Sedentary Behavior and Metabolic Syndrome, run by University of Bedfordshire at 1 site in United Kingdom.
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 7 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 Nov 2020. 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 Kingdom. 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?
Feasibility - Adherence: Drop-out rates in control and intervention group (time frame: From recruitment (typically 4 weeks prior to baseline) up to study completion (typically 12 weeks)). 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 13 Nov 2020.