Health BehaviorNCT02136381
Lifestyle Interventions at Retirement
A study testing LEAP intervention in people with Health Behavior, run by Newcastle University at 1 site in United Kingdom.
Trial summary
The LiveWell research programme aims to develop evidence-based, acceptable and scalable interventions to improve health and wellbeing in the retirement transition. Life stage transitions involve changes in lifestyle and thus present key opportunities for behaviour change interventions. Read more about this study
- Who is it for?
- Ages 55 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- LEAP intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2014to Feb 2015
- 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 55 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults within 2 years (before/after) retirement from full time work
- Healthy volunteers
- Internet users
- English language speakers
Who cannot join
- Non-internet users
- Non-English speakers
- Not within the peri-retirement period (within two years of retirement)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Human Nutrition Research Centre, Institute for Ageing and Health, Newcastle University
Newcastle upon Tyne, Tyne and Wear, NE45PL
John C Mathers, PhD, +44 (0) 1912081133, john.mathers@ncl.ac.uk
Jose Lara, PhD, +44 (0) 1912081141, jose.lara@ncl.ac.uk
About this study
Official title: Pilot Randomised Controlled Trial of an Internet-based Lifestyle Intervention for People Around Retirement
The LiveWell research programme aims to develop evidence-based, acceptable and scalable interventions to improve health and wellbeing in the retirement transition.
Life stage transitions involve changes in lifestyle and thus present key opportunities for behaviour change interventions. Our assessment of the literature shows that interventions with people of retirement age can effectively promote components of the Mediterranean diet (Lara et al, BMC Medicine Apr 8;12(1):60: 2014), physical activity (Hobbs et al, BMC Medicine Mar 19;11:75; 2013) and explicit social roles (Heaven et al, Milbank Q. Jun;91(2):222-87: 2013).
Read more
This study is a 2-month randomised controlled trial (RCT) with two intervention arms taking place in the North-East of England.
We have developed an internet-based lifestyle programme (Living, Eating, Activity and Planning through retirement (LEAP)) that promotes three key health and social behaviours; 1) healthy eating by adopting a Mediterranean diet, 2) increasing physical activity with the use of a step-counter, and 3) improving social connectedness.
Participants recruited for this study will be allocated in random order with a ratio of 2:1 to the intervention group (LEAP) or to a control group.
This study will evaluate the feasibility and acceptability of the LEAP intervention among people of retirement age and will pilot trial procedures.
In this programme of research we have also defined a suite of outcome measures and identified tools appropriate for capturing the Healthy Ageing Phenotype (HAP) (Lara et al, Maturitas. 2013 Oct;76(2):189-99). We will assess aspects of Cognition, Physical capability, Physiological outcomes, and psycho-social wellbeing. The feasibility and acceptability of these measures has yet to be determined and therefore will be formally assessed in this pilot RCT alongside more proximal outcomes of the intervention modules (i.e. diet, physical activity and social roles).
The hypotheses to be tested in the LiveWell programme are as follows:
- A newly developed internet-based lifestyle programme (Living, Eating, Activity and Planning through retirement (LEAP)) is an acceptable tool for behaviour change among people of peri-retirement age.
- A suite of outcome measures and identified tools appropriate for capturing the Healthy Ageing Phenotype (HAP) is acceptable among people of peri-retirement age.
Read the detailed description
This intervention will last two months.
Participants will attend a 2-hour session with the researchers in order to provide signed consent and undergo the baseline assessment of healthy-ageing related outcome measures. Participants will attend a second 2-hour session after two months to repeat the assessment.
The assessments will take place at the participant's place of work. Participants who have retired will be asked to attend assessments at their previous place of work, at a local privately hired venue (e.g. community hall), or in their own homes.
Semi-structured interviews (n=28) will be conducted with a sample of participants from the intervention and control groups and two 'reduced participation' groups.
The reduced participation groups will include people who decline to participate in the trial but consent to a brief qualitative interview about their decision not to participate (after initially expressing interest) (n= up to 2), and people who withdraw from the trial but consent to a follow-up interview (n= up to 2).
The interviews will address three overlapping domains of enquiry: 1) questions relating to participation in the pilot study; 2) questions relating to use of the intervention website; and 3) questions relating to the use of the HAP set of measurement tools.
- Conditions
- Health Behavior
- Being tested
- LEAP intervention, Control
- Keywords
- Lifestyle, interventions, retirement
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEAP interventionBehavioural
LEAP has 5 modules of tools and resources. LEAP is personalised based on information provided at different stages. The user determines the modules to complete (skipping or revisiting modules). Users can choose among 8 animated mentors (4 female; 4 male) to guide them through the intervention.
Users will provide demographic data, health-related information, and current lifestyles in order to tailor the advice to be received.
Advice will focus on adopting elements of a Mediterranean dietary pattern, increase physical activity, and improve social connectedness.
Participants will receive 1) Mediterranean diet recipes; 2) a step counter to monitor physical activity goals; 3) advice in how to enhance social engagement and facilitate social roles
ControlBehavioural
Thirty participants will be randomised to a minimal intervention comparator condition, where participants will be emailed a direct link to the National Health Service (NHS) choices 'LiveWell' website (http://www.nhs.uk/LiveWell/Pages/Livewellhub.aspx).
The email will encourage the participants to access the health resources and information on the pages labelled men's health 40-60, men's health 60-plus, women's health 40-60, women's health 60-plus, as appropriate.
Participants in the control group will be assessment after two months.
| Study group | Role | What they receive |
|---|---|---|
| LEAP intervention | Experimental | A newly developed internet-based lifestyle programme (Living, Eating, Activity and Planning through retirement (LEAP)) will promote three key health and social behaviours; healthy eating following a Mediterranean diet, increasing physical activity and improve social connectedness. Receives: Behavioral: LEAP intervention |
| Control | Other | Thirty participants will be randomised to a minimal intervention comparator condition, where participants will be emailed a direct link to the National Health Service (NHS) choices 'LiveWell' website (http://www.nhs.uk/LiveWell/Pages/Livewellhub.aspx).
This website contains general information on improving life style and health. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability of intervention
Participants will complete a questionnaire directed to obtain early markers of how the intervention is used
Measured: 2 months
Secondary outcomes (27)
Functional outcomes
At baseline and at 2 months post-randomisation, participants will be asked to complete a series of tests to assess the impact of the programme on the following health-related indices:
- Resting blood pressure
- Lung function by spirometry (a breathing test measuring how much air someone can breathe in and out. It also measures how fast you can blow air out)
- Dexterity test (measuring the ability to coordinate fingers to manipulate objects quickly and accurately)
- Handgrip strength (a measure of muscle strength)
- Walking speed (measured by walking 4 meters at a normal pace)
- Endurance (measured by walking at a fast pace for 2 minutes)
- Standing balance
- Sit-to-stand test
- Timed-up-and-go test
- Cognitive function tests (such as memory and attention tests completed on a touchscreen computer)
- Psycho-social wellbeing tests (completed on a computer).
Measured: At 0 and 2 months
Change from baseline physical activity levels at 2 months
Physical activity will be assessed assessed during seven days at baseline and after 2 months interventions by accelerometry.
Measured: 0 and 2 months
Change from baseline dietary intake
Participants will self-report dietary intake using the 24-hour dietary recall method. Three days (including 2 weekdays and 1 weekend day) of dietary intake at baseline and after two months will be reported.
Measured: 0 and 2 months
Change from baseline resting blood pressure at 2 months
Measured: 0 and 2 months
Change from baseline lung function at 2 months
Lung function will be measured by spirometry (a breathing test measuring how much air someone can breathe in and out. It also measures how fast you can blow air out)
Measured: 0 and 2 months
Change from baseline dexterity at 2 months
The National Institutes of Health Toolbox dexterity test, involving the 9-hole pegboard test (measuring the ability to coordinate fingers to manipulate objects quickly and accurately), will be used.
Measured: 0 and 2 months
Change from baseline Handgrip strength at 2 months
Measured: 0 and 2 months
Change from baseline walking speed at 2 months
Walking speed will be measured by walking 4 meters at a normal pace
Measured: 0 and 2 months
Change from baseline endurance at 2 months
Endurance will be measured as the total distance walked at a fast pace during 2 minutes
Measured: 0 and 2 months
Change from baseline standing balance at 2 months
Measured: 0 and 2 months
Change from baseline functional change of transitional movements at 2 months
The sit-to-stand test will be used
Measured: 0 and 2 months
Change from baseline mobility at 2 months
The timed-up-and-go test will be used
Measured: 0 and 2 months
Change from baseline episodic memory at 2 months
The Paired Associates Learning (PAL) episodic memory test will be used
Measured: 0 and 2 months
Change from baseline verbal and category fluency at 2 months
The verbal and category fluency test will be used
Measured: 0 and 2 months
Change from baseline processing speed at 2 months
The letter digit substitution test will be used
Measured: 0 and 2 months
Change from baseline life satisfaction at 2 months
The satisfaction with life scale will be used
Measured: 0 and 2 months
Change from baseline quality of life at 2 months
The World Health Organization Quality of Life scale (WHOQoL-BREF) will be used
Measured: 0 and 2 months
Change from baseline meaning and purpose at 2 months
The National Institutes of health toolbox meaning and purpose test will be used
Measured: 0 and 2 months
Change from baseline social companionship at 2 months
The companionship scale of the Patient-Reported Outcomes Measurement Information System (PROMIS) will be used
Measured: 0 and 2 months
Change from baseline emotional support at 2 months
The Patient-Reported Outcomes Measurement Information System (PROMIS) emotional support scale will be used
Measured: 0 and 2 months
Change from baseline social functioning at 2 months
The Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction with social roles scale will be used
Measured: 0 and 2 months
Acceptability, feasibility and compliance with the healthy ageing phenotype (HAP) battery assessment procedures
Participants will complete a questionnaire directed to evaluate the acceptability, feasibility and compliance with the healthy ageing phenotype (HAP) battery assessment procedures
Measured: 2 months
Change from baseline positive affect at 2 months
The National Institutes of Health toolbox "positive affect scale" will be used
Measured: 0 and 2 months
Change from baseline instrumental support at 2 months
The National Institutes of Health toolbox "instrumental support" scale will be used
Measured: 0 and 2 months
Change from baseline satisfaction with social roles and activities at 2 months
The National Institutes of Health toolbox "satisfaction with social roles and activities" scale will be used.
Measured: 0 and 2 months
Change from baseline social isolation at 2 months
The National Institutes of Health toolbox "social isolation" scale will be used
Measured: 0 and 2 months
Change from baseline depression scale at 2 months
The Center for Epidemiologic Studies Depression Scale (CES-D) will be used
Measured: 0 and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John C Mathers, PhD, Study director, Human Nutrition Research Centre, Institute for Ageing and Health, Newcastle UniversityMartin White, PhD, Principal investigator, Institute for Health and Society, Newcastle UniversityFalko F Sniehotta, PhD, Principal investigator, Institute for Health and Society, Newcastle UniversityLynn Rochester, PhD, Principal investigator, Newcastle UniversityMoynihan J Paula, PhD, Principal investigator, Newcastle UniversityThomas D Meyer, PhD, Principal investigator, Institute of Neuroscience, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136381
- Sponsor's protocol ID
- LiveWell_00745/2014
- Status last verified
- May 2014
- First submitted
- 28 Apr 2014
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lara J, O'Brien N, Godfrey A, Heaven B, Evans EH, Lloyd S, Moffatt S, Moynihan PJ, Meyer TD, Rochester L, Sniehotta FF, White M, Mathers JC. Pilot Randomised Controlled Trial of a Web-Based Intervention to Promote Healthy Eating, Physical Activity and Meaningful Social Connections Compared with Usual Care Control in People of Retirement Age Recruited from Workplaces. PLoS One. 2016 Jul 29;11(7):e0159703. doi: 10.1371/journal.pone.0159703. eCollection 2016.
PubMed 27472560
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomised Controlled Trial of an Internet-based Lifestyle Intervention for People Around Retirement
- ClinicalTrials.gov ID
- NCT02136381
- Acronym / sponsor ID
- LiveWell_00745/2014
- Conditions
- Health Behavior
- Keywords
- Lifestyle, interventions, retirement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 13 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The LiveWell research programme aims to develop evidence-based, acceptable and scalable interventions to improve health and wellbeing in the retirement transition.
Life stage transitions involve changes in lifestyle and thus present key opportunities for behaviour change interventions. Our assessment of the literature shows that interventions with people of retirement age can effectively promote components of the Mediterranean diet (Lara et al, BMC Medicine Apr 8;12(1):60: 2014), physical activity (Hobbs et al, BMC Medicine Mar 19;11:75; 2013) and explicit social roles (Heaven et al, Milbank Q. Jun;91(2):222-87: 2013).
This study is a 2-month randomised controlled trial (RCT) with two intervention arms taking place in the North-East of England.
We have developed an internet-based lifestyle programme (Living, Eating, Activity and Planning through retirement (LEAP)) that promotes three key health and social behaviours; 1) healthy eating by adopting a Mediterranean diet, 2) increasing physical activity with the use of a step-counter, and 3) improving social connectedness.
Participants recruited for this study will be allocated in random order with a ratio of 2:1 to the intervention group (LEAP) or to a control group.
This study will evaluate the feasibility and acceptability of the LEAP intervention among people of retirement age and will pilot trial procedures.
In this programme of research we have also defined a suite of outcome measures and identified tools appropriate for capturing the Healthy Ageing Phenotype (HAP) (Lara et al, Maturitas. 2013 Oct;76(2):189-99). We will assess aspects of Cognition, Physical capability, Physiological outcomes, and psycho-social wellbeing. The feasibility and acceptability of these measures has yet to be determined and therefore will be formally assessed in this pilot RCT alongside more proximal outcomes of the intervention modules (i.e. diet, physical activity and social roles).
The hypotheses to be tested in the LiveWell programme are as follows:
- A newly developed internet-based lifestyle programme (Living, Eating, Activity and Planning through retirement (LEAP)) is an acceptable tool for behaviour change among people of peri-retirement age.
- A suite of outcome measures and identified tools appropriate for capturing the Healthy Ageing Phenotype (HAP) is acceptable among people of peri-retirement age.
Detailed description
This intervention will last two months.
Participants will attend a 2-hour session with the researchers in order to provide signed consent and undergo the baseline assessment of healthy-ageing related outcome measures. Participants will attend a second 2-hour session after two months to repeat the assessment.
The assessments will take place at the participant's place of work. Participants who have retired will be asked to attend assessments at their previous place of work, at a local privately hired venue (e.g. community hall), or in their own homes.
Semi-structured interviews (n=28) will be conducted with a sample of participants from the intervention and control groups and two 'reduced participation' groups.
The reduced participation groups will include people who decline to participate in the trial but consent to a brief qualitative interview about their decision not to participate (after initially expressing interest) (n= up to 2), and people who withdraw from the trial but consent to a follow-up interview (n= up to 2).
The interviews will address three overlapping domains of enquiry: 1) questions relating to participation in the pilot study; 2) questions relating to use of the intervention website; and 3) questions relating to the use of the HAP set of measurement tools.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LEAP intervention | Experimental | Behavioral: LEAP interventionA newly developed internet-based lifestyle programme (Living, Eating, Activity and Planning through retirement (LEAP)) will promote three key health and social behaviours; healthy eating following a Mediterranean diet, increasing physical activity and improve social connectedness. |
| Control | Other | Behavioral: ControlThirty participants will be randomised to a minimal intervention comparator condition, where participants will be emailed a direct link to the National Health Service (NHS) choices 'LiveWell' website (http://www.nhs.uk/LiveWell/Pages/Livewellhub.aspx). This website contains general information on improving life style and health. |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults within 2 years (before/after) retirement from full time work
- Healthy volunteers
- Internet users
- English language speakers
Key exclusion criteria (3 listed)
- Non-internet users
- Non-English speakers
- Not within the peri-retirement period (within two years of retirement)
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 |
|---|---|---|
| LEAP interventionLEAP has 5 modules of tools and resources. LEAP is personalised based on information provided at different stages. The user determines the modules to complete (skipping or revisiting modules). Users can choose among 8 animated mentors (4 female; 4 male) to guide them through the intervention. Users will provide demographic data, health-related information, and current lifestyles in order to tailor the advice to be received. Advice will focus on adopting elements of a Mediterranean dietary pattern, increase physical activity, and improve social connectedness. Participants will receive 1) Mediterranean diet recipes; 2) a step counter to monitor physical activity goals; 3) advice in how to enhance social engagement and facilitate social roles | Behavioural | LEAP intervention |
| ControlThirty participants will be randomised to a minimal intervention comparator condition, where participants will be emailed a direct link to the National Health Service (NHS) choices 'LiveWell' website (http://www.nhs.uk/LiveWell/Pages/Livewellhub.aspx). The email will encourage the participants to access the health resources and information on the pages labelled men's health 40-60, men's health 60-plus, women's health 40-60, women's health 60-plus, as appropriate. Participants in the control group will be assessment after two months. | Behavioural | Control |
Primary outcome
Feasibility and acceptability of intervention
Time frame: 2 months
Participants will complete a questionnaire directed to obtain early markers of how the intervention is used
27 secondary outcomes
Functional outcomes
Time frame: At 0 and 2 months
Change from baseline physical activity levels at 2 months
Time frame: 0 and 2 months
Change from baseline dietary intake
Time frame: 0 and 2 months
Change from baseline resting blood pressure at 2 months
Time frame: 0 and 2 months
Change from baseline lung function at 2 months
Time frame: 0 and 2 months
Change from baseline dexterity at 2 months
Time frame: 0 and 2 months
Change from baseline Handgrip strength at 2 months
Time frame: 0 and 2 months
Change from baseline walking speed at 2 months
Time frame: 0 and 2 months
Change from baseline endurance at 2 months
Time frame: 0 and 2 months
Change from baseline standing balance at 2 months
Time frame: 0 and 2 months
Change from baseline functional change of transitional movements at 2 months
Time frame: 0 and 2 months
Change from baseline mobility at 2 months
Time frame: 0 and 2 months
Change from baseline episodic memory at 2 months
Time frame: 0 and 2 months
Change from baseline verbal and category fluency at 2 months
Time frame: 0 and 2 months
Change from baseline processing speed at 2 months
Time frame: 0 and 2 months
Change from baseline life satisfaction at 2 months
Time frame: 0 and 2 months
Change from baseline quality of life at 2 months
Time frame: 0 and 2 months
Change from baseline meaning and purpose at 2 months
Time frame: 0 and 2 months
Change from baseline social companionship at 2 months
Time frame: 0 and 2 months
Change from baseline emotional support at 2 months
Time frame: 0 and 2 months
Change from baseline social functioning at 2 months
Time frame: 0 and 2 months
Acceptability, feasibility and compliance with the healthy ageing phenotype (HAP) battery assessment procedures
Time frame: 2 months
Change from baseline positive affect at 2 months
Time frame: 0 and 2 months
Change from baseline instrumental support at 2 months
Time frame: 0 and 2 months
Change from baseline satisfaction with social roles and activities at 2 months
Time frame: 0 and 2 months
Change from baseline social isolation at 2 months
Time frame: 0 and 2 months
Change from baseline depression scale at 2 months
Time frame: 0 and 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
- Derived from this study: PubMed 27472560Lara J, O'Brien N, Godfrey A, Heaven B, Evans EH, Lloyd S, Moffatt S, Moynihan PJ, Meyer TD, Rochester L, Sniehotta FF, White M, Mathers JC. Pilot Randomised Controlled Trial of a Web-Based Intervention to Promote Healthy Eating, Physical Activity and Meaningful Social Connections Compared with Usual Care Control in People of Retirement Age Recruited from Workplaces. PLoS One. 2016 Jul 29;11(7):e0159703. doi: 10.1371/journal.pone.0159703. eCollection 2016.
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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.
John C Mathers, PhD study director
Human Nutrition Research Centre, Institute for Ageing and Health, Newcastle University
Martin White, PhD principal investigator
Institute for Health and Society, Newcastle University
Falko F Sniehotta, PhD principal investigator
Institute for Health and Society, Newcastle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LEAP intervention in people with Health Behavior, run by Newcastle University 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 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: status not confirmed, as of the sponsor's last update on 13 May 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John C Mathers, PhD (+44 (0) 1912081133, john.mathers@ncl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and acceptability of intervention (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02136381, which also lists 1 linked publication.
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 May 2014; AzTrials last refreshed its copy on 28 Oct 2026.