ExerciseEarly Phase 1NCT01150084
"Step by Step": A Feasibility Study of the Promotion of Lunchtime Walking to Increase Physical Activity and Improve Mental Well-being in Sedentary Employees
A Early Phase 1 study testing 16-week lunchtime walking intervention and delayed treatment in people with Exercise and Sedentary, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
Increasing rates of sedentary living, often complemented by obesity, among large segments of the adult population are associated with costs to individual health and well-being and thereby to society as a whole. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- 16-week lunchtime walking intervention and delayed treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2009to Mar 2011
- Phase
- Early Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy, mobile, 18-65 year old employees who report they are engaging in less than 30 minutes of moderate intensity physical activity per week
Who cannot join
- employees with significant auditory or visual problems and those who have severe musculoskeletal disorders that prevent them from engaging in physical activity. Medical clearance will be requested for those who report any cardiovascular disease.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Birmingham
Birmingham, West Midlands, B15 2TT
About this study
Increasing rates of sedentary living, often complemented by obesity, among large segments of the adult population are associated with costs to individual health and well-being and thereby to society as a whole. Although some workplaces offer physical activity opportunities, those employees who tend to need it the most (i.e., the health needy) are often not attracted. In this project, the investigators propose to develop and evaluate a programme that is targeted to the sedentary health needy employees. The investigators will work with the corporate partner (a large university) to attract such employees through an extensive social marketing driven campaign. A 16-week lunchtime walking programme is proposed in which walking groups are offered followed by support and motivational strategies for longer term independent walking. The investigators will examine the effects of the programme on total amount of walking (including a follow-up assessment 4 months later) and will use innovative technology (Smartphones) to also examine the effect of lunchtime walks on well-being and work performance within and between participants.
- Being tested
- 16-week lunchtime walking intervention, delayed treatment
- Keywords
- increasing physical activity in sedentary employees
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16-week lunchtime walking interventionOther
10 week group led lunchtime walks (each 30 minutes) followed by 6 weeks independent walking
delayed treatmentOther
to start at week 10
| Study group | Role | What they receive |
|---|---|---|
| lunchtime walking | Experimental | Not described Receives: Other: 16-week lunchtime walking intervention |
| waiting-list control | Other | Not described Receives: Other: delayed treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of steps
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2010 (estimated)
- Study startSep 2009
- Primary completionDec 2010 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Bupa Chile
- Investigators
- Cecilie Thogersen-Ntoumani, PhD, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150084
- Sponsor's protocol ID
- ISRCTN01150084
- Other IDs
- ISRCTN01150084
- Status last verified
- Sep 2009
- First submitted
- 23 Jun 2010
- Last updated
- 28 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Step by Step": A Feasibility Study of the Promotion of Lunchtime Walking to Increase Physical Activity and Improve Mental Well-being in Sedentary Employees
- ClinicalTrials.gov ID
- NCT01150084
- Acronym / sponsor ID
- ISRCTN01150084
- Keywords
- increasing physical activity in sedentary employees
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Bupa Chile
- Study start
- Sep 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 24 Jun 2010 (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.
Increasing rates of sedentary living, often complemented by obesity, among large segments of the adult population are associated with costs to individual health and well-being and thereby to society as a whole. Although some workplaces offer physical activity opportunities, those employees who tend to need it the most (i.e., the health needy) are often not attracted. In this project, the investigators propose to develop and evaluate a programme that is targeted to the sedentary health needy employees. The investigators will work with the corporate partner (a large university) to attract such employees through an extensive social marketing driven campaign. A 16-week lunchtime walking programme is proposed in which walking groups are offered followed by support and motivational strategies for longer term independent walking. The investigators will examine the effects of the programme on total amount of walking (including a follow-up assessment 4 months later) and will use innovative technology (Smartphones) to also examine the effect of lunchtime walks on well-being and work performance within and between participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lunchtime walking | Experimental | Other: 16-week lunchtime walking intervention |
| waiting-list control | Other | Other: delayed treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy, mobile, 18-65 year old employees who report they are engaging in less than 30 minutes of moderate intensity physical activity per week
Key exclusion criteria (1 listed)
- employees with significant auditory or visual problems and those who have severe musculoskeletal disorders that prevent them from engaging in physical activity. Medical clearance will be requested for those who report any cardiovascular disease.
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 |
|---|---|---|
| 16-week lunchtime walking intervention10 week group led lunchtime walks (each 30 minutes) followed by 6 weeks independent walking | Other | lunchtime walking |
| delayed treatmentto start at week 10 | Other | waiting-list control |
Primary outcome
number of steps
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2010.
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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.
Cecilie Thogersen-Ntoumani, PhD principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 16-week lunchtime walking intervention and delayed treatment in people with Exercise and Sedentary, run by University of Birmingham 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 1 inclusion and 1 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 28 Jun 2010. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
number of steps (time frame: 8 months). 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 28 Jun 2010.