Public HealthBoosterNCT00836459
Sheffield Physical Activity Booster Trial
A study testing Mini Booster and Full Booster in people with Public Health, run by Richard Hudson at 1 site in United Kingdom.
Trial summary
Adults that increase their physical activity can improve their health, and reduce future risks to health, but long-term changes are difficult to sustain. This study assesses whether it is worth providing further support, 3 months after giving initial advice, to those who have managed to do more physical activity. Read more about this study
- Who is it for?
- Ages 40 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Public Health
- What is being tested?
- Mini Booster and Full Booster
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2009to Dec 2013
- 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 40 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Residents of the 20 most deprived neighbourhoods in the city of Sheffield
- Aged 40 to 64 years
- Not achieving the current recommended activity level (30 mins of moderate activity on at least 5 days) assessed using the SPAQ (Lowther, 1999) and wishing to have support to become more active
Who cannot join
- Have increased their physical activity level by at least 30 mins of moderate or vigorous activity per week (assessed using the SPAQ) since initial assessment of activity level
- Capacity to give written informed consent to trial participation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Sport and Exercise Science, Sheffield Hallam University
Sheffield, South Yorkshire, S10 2BP
About this study
Official title: A Randomised Controlled Trial and Cost-effectiveness Evaluation of "Booster" Interventions to Sustain Increases in Physical Activity in Middle-aged Adults in Deprived Urban Neighbourhoods.
Adults that increase their physical activity can improve their health, and reduce future risks to health, but long-term changes are difficult to sustain. This study assesses whether it is worth providing further support, 3 months after giving initial advice, to those who have managed to do more physical activity. All participants will initially be given an interactive DVD. A researcher from Sheffield Hallam University will provide two telephone follow ups at one month intervals to assess physical activity levels. Only those that have increased their physical activity at this point will remain in the study. These participants will receive a "mini booster", a "full booster" or no booster. The "mini booster" consists of a two telephone calls one month apart to discuss physical activity and usage of the DVD. A "full booster" consists of a face-to-face meeting with the facilitator at the same intervals. The purpose of these booster sessions is to help the individual to maintain their increase in physical activity. The investigators will measure the differences in physical activity, quality of life and costs, associated with the booster interventions, 3 months and 9 months from randomisation. The research will be carried out in 20 of the most deprived neighbourhoods in Sheffield. These locations have large, ethnically diverse populations, high levels of economic deprivation, low levels of physical activity, poorer health and shorter life expectancy. Participants will be recruited through general practices and community groups, as well as by postal invitation to ensure the participation of minority ethnic groups and those with lower levels of literacy. Sheffield City Council and Primary Care Trust fund a range of facilities and activities to promote physical activity and variations in access to these between neighbourhoods will make it possible to examine whether the effectiveness of the intervention is modified by access to community facilities.
- Conditions
- Public Health
- Being tested
- Mini Booster, Full Booster
- Keywords
- Humans, Middle Aged, Behavior Therapy, Directive Counseling, Health Behavior, Interview, Psychological, Motivation, Exercise, Physical Fitness, Self Efficacy, Life Style, Health Promotion, Health Knowledge, Attitudes, Practice, Body Mass Index, Monitoring, Ambulatory, Walking
- Medical subject headings
- Health Behavior, Motor Activity, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini BoosterBehavioural
Two telephone-based physical activity consultations, delivered in a motivational interviewing style, at one month and two months from randomisation
Full BoosterBehavioural
Two face-to-face physical activity consultations, delivered in a motivational interviewing style, at one month and two months from randomisation
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Mini Booster | Experimental | Not described Receives: Behavioral: Mini Booster |
| Full Booster | Experimental | Not described Receives: Behavioral: Full Booster |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity measured by accelerometry.
Measured: 3 months post-randomisation
Secondary outcomes (6)
Physical activity assessed by accelerometry.
Measured: 9 months post-randomisation
Self-reported moderate or strenuous physical activity using the Scottish Physical Activity Questionnaire (SPAQ, incorporating Stage of Change information) which records type and duration of activities in the previous week
Measured: 3 months and 9 months post-randomisation
Health-related quality of life using the Sheffield Version SF-12v2 plus 4 survey instrument
Measured: 3 months and 9 months post-randomisation
Self-reported use of community facilities for physical activity
Measured: 3 months and 9 months post-randomisation
Self-reported health and social care contacts
Measured: 3 months and 9 months post-randomisation
Psychological measures of motivation, assessed using BREQ-2 (Mullan et al, 1997)
Measured: 3 months and 9 months post-randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Public HealthStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Richard Hudson
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Health Technology Assessment Programme
- Responsible party
- Sponsor-investigator, Richard Hudson, University of Sheffield
- Investigators
- Liddy Goyder, MD FFPH, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836459
- Sponsor's protocol ID
- 120243
- Other IDs
- HTA: 07/25/02, IRAS: 08/H1308/270
- Acronym
- Booster
- Status last verified
- Dec 2014
- First submitted
- 3 Feb 2009
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Goyder, Elizabeth, et al.
Copeland RJ, Horspool K, Humphreys L, Scott E; Booster trial team. Recruiting to a large-scale physical activity randomised controlled trial - experiences with the gift of hindsight. Trials. 2016 Feb 24;17(1):104. doi: 10.1186/s13063-016-1229-0.
PubMed 26908117Goyder E, Hind D, Breckon J, Dimairo M, Minton J, Everson-Hock E, Read S, Copeland R, Crank H, Horspool K, Humphreys L, Hutchison A, Kesterton S, Latimer N, Scott E, Swaile P, Walters SJ, Wood R, Collins K, Cooper C. A randomised controlled trial and cost-effectiveness evaluation of 'booster' interventions to sustain increases in physical activity in middle-aged adults in deprived urban neighbourhoods. Health Technol Assess. 2014 Feb;18(13):1-210. doi: 10.3310/hta18130.
PubMed 24571932Hind D, Scott EJ, Copeland R, Breckon JD, Crank H, Walters SJ, Brazier JE, Nicholl J, Cooper C, Goyder E. A randomised controlled trial and cost-effectiveness evaluation of "booster" interventions to sustain increases in physical activity in middle-aged adults in deprived urban neighbourhoods. BMC Public Health. 2010 Jan 4;10:3. doi: 10.1186/1471-2458-10-3.
PubMed 20047672
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial and Cost-effectiveness Evaluation of "Booster" Interventions to Sustain Increases in Physical Activity in Middle-aged Adults in Deprived Urban Neighbourhoods.
- ClinicalTrials.gov ID
- NCT00836459
- Acronym / sponsor ID
- Booster / 120243
- Conditions
- Public Health
- Keywords
- Humans, Middle Aged, Behavior Therapy, Directive Counseling, Health Behavior, Interview, Psychological, Motivation, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Richard HudsonUniversity, hospital or other
- Collaborators
- NHS Health Technology Assessment Programme
- Study start
- Nov 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 4 Feb 2009 (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.
Adults that increase their physical activity can improve their health, and reduce future risks to health, but long-term changes are difficult to sustain. This study assesses whether it is worth providing further support, 3 months after giving initial advice, to those who have managed to do more physical activity. All participants will initially be given an interactive DVD. A researcher from Sheffield Hallam University will provide two telephone follow ups at one month intervals to assess physical activity levels. Only those that have increased their physical activity at this point will remain in the study. These participants will receive a "mini booster", a "full booster" or no booster. The "mini booster" consists of a two telephone calls one month apart to discuss physical activity and usage of the DVD. A "full booster" consists of a face-to-face meeting with the facilitator at the same intervals. The purpose of these booster sessions is to help the individual to maintain their increase in physical activity. The investigators will measure the differences in physical activity, quality of life and costs, associated with the booster interventions, 3 months and 9 months from randomisation. The research will be carried out in 20 of the most deprived neighbourhoods in Sheffield. These locations have large, ethnically diverse populations, high levels of economic deprivation, low levels of physical activity, poorer health and shorter life expectancy. Participants will be recruited through general practices and community groups, as well as by postal invitation to ensure the participation of minority ethnic groups and those with lower levels of literacy. Sheffield City Council and Primary Care Trust fund a range of facilities and activities to promote physical activity and variations in access to these between neighbourhoods will make it possible to examine whether the effectiveness of the intervention is modified by access to community facilities.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Mini Booster | Experimental | Behavioral: Mini Booster |
| Full Booster | Experimental | Behavioral: Full Booster |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Residents of the 20 most deprived neighbourhoods in the city of Sheffield
- Aged 40 to 64 years
- Not achieving the current recommended activity level (30 mins of moderate activity on at least 5 days) assessed using the SPAQ (Lowther, 1999) and wishing to have support to become more active
Key exclusion criteria (2 listed)
- Have increased their physical activity level by at least 30 mins of moderate or vigorous activity per week (assessed using the SPAQ) since initial assessment of activity level
- Capacity to give written informed consent to trial participation
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 |
|---|---|---|
| Mini BoosterTwo telephone-based physical activity consultations, delivered in a motivational interviewing style, at one month and two months from randomisation | Behavioural | Mini Booster |
| Full BoosterTwo face-to-face physical activity consultations, delivered in a motivational interviewing style, at one month and two months from randomisation | Behavioural | Full Booster |
Primary outcome
Physical activity measured by accelerometry.
Time frame: 3 months post-randomisation
6 secondary outcomes
Physical activity assessed by accelerometry.
Time frame: 9 months post-randomisation
Self-reported moderate or strenuous physical activity using the Scottish Physical Activity Questionnaire (SPAQ, incorporating Stage of Change information) which records type and duration of activities in the previous week
Time frame: 3 months and 9 months post-randomisation
Health-related quality of life using the Sheffield Version SF-12v2 plus 4 survey instrument
Time frame: 3 months and 9 months post-randomisation
Self-reported use of community facilities for physical activity
Time frame: 3 months and 9 months post-randomisation
Self-reported health and social care contacts
Time frame: 3 months and 9 months post-randomisation
Psychological measures of motivation, assessed using BREQ-2 (Mullan et al, 1997)
Time frame: 3 months and 9 months post-randomisation
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 2 Dec 2014.
- Results publicationGoyder, Elizabeth, et al.
- Derived from this study: PubMed 26908117Copeland RJ, Horspool K, Humphreys L, Scott E; Booster trial team. Recruiting to a large-scale physical activity randomised controlled trial - experiences with the gift of hindsight. Trials. 2016 Feb 24;17(1):104. doi: 10.1186/s13063-016-1229-0.
- Derived from this study: PubMed 24571932Goyder E, Hind D, Breckon J, Dimairo M, Minton J, Everson-Hock E, Read S, Copeland R, Crank H, Horspool K, Humphreys L, Hutchison A, Kesterton S, Latimer N, Scott E, Swaile P, Walters SJ, Wood R, Collins K, Cooper C. A randomised controlled trial and cost-effectiveness evaluation of 'booster' interventions to sustain increases in physical activity in middle-aged adults in deprived urban neighbourhoods. Health Technol Assess. 2014 Feb;18(13):1-210. doi: 10.3310/hta18130.
- Derived from this study: PubMed 20047672Hind D, Scott EJ, Copeland R, Breckon JD, Crank H, Walters SJ, Brazier JE, Nicholl J, Cooper C, Goyder E. A randomised controlled trial and cost-effectiveness evaluation of "booster" interventions to sustain increases in physical activity in middle-aged adults in deprived urban neighbourhoods. BMC Public Health. 2010 Jan 4;10:3. doi: 10.1186/1471-2458-10-3.
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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.
Liddy Goyder, MD FFPH principal investigator
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini Booster and Full Booster in people with Public Health, run by Richard Hudson 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 3 inclusion and 2 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 2 Dec 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?
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?
Physical activity measured by accelerometry. (time frame: 3 months post-randomisation). 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 NCT00836459, which also lists 4 linked publications.
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 2 Dec 2014.