Sheffield physical activity booster trial
| ISRCTN | ISRCTN56495859 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56495859 |
| ClinicalTrials.gov number | NCT00836459 |
| Secondary identifying numbers | HTA 07/25/02; 120243 |
- Submission date
- 12/02/2009
- Registration date
- 16/02/2009
- Last edited
- 11/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
Adults who 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. 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.
Who can participate?
Residents of the 20 most deprived neighbourhoods in the city of Sheffield, aged 40 to 64, who are not achieving the current recommended activity level.
What does the study involve?
All participants are initially given an interactive DVD. A researcher contacts them twice at one month intervals to assess their physical activity levels. Only those who have increased their physical activity at this point remain in the study. These participants are randomly allocated to receive either 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 participants to maintain their increase in physical activity. After 3 and 9 months we measure the differences in physical activity, quality of life and costs associated with the booster interventions.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
University of Sheffield (UK)
When is the study starting and how long is it expected to run for?
April 2009 to March 2013
Who is funding the study?
Health Technology Assessment Programme (UK)
Who is the main contact?
Dr Elizabeth Goyder
e.goyder@sheffield.ac.uk
Contact information
Scientific
University of Sheffield
Regent Court
30 Regent St
Sheffield
S1 4DA
United Kingdom
| e.goyder@sheffield.ac.uk |
Study information
| Study design | Open-label parallel-group randomised controlled single-centre trial, with a feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific 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 |
| Study acronym | Booster Study |
| Study hypothesis | 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. Further details can be found at: http://www.nets.nihr.ac.uk/projects/hta/072502 Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0005/51746/PRO-07-25-02.pdf |
| Ethics approval(s) | North Sheffield Local Research Ethics Committee, approval pending as of 12/02/2009 |
| Condition | Physical activity levels in middle-aged adults |
| Intervention | The participants will be individually randomised to the following three arms: 1. Mini Booster: Two telephone-based physical activity consultations, delivered in a motivational interviewing style, at one month and two months from randomisation. Duration of treatment 2 months, duration of follow-up 9 months. 2. Full Booster: Two face-to-face physical activity consultations, delivered in a motivational interviewing style, at one month and two months from randomisation. Duration of treatment 2 months, duration of follow-up 9 months. 3. Control: No Intervention. Duration of follow-up is 9 months. |
| Intervention type | Other |
| Primary outcome measure | Physical activity measured by 7-day accelerometric assessment (recoded as counts per week) at 3 months post-randomisation. |
| Secondary outcome measures | 1. Physical activity measured by 7-day accelerometric assessment (recoded as counts per week) at 9 months post-randomisation 2. Self-reported moderate or strenuous physical activity using the SSPAQ (incorporating Stage of Change information) which records type and duration of activities in the previous week (at 3 and 9 months post randomisation) 3. Health-related quality of life using the Sheffield Version SF-12v2 plus 4 survey instrument (at 3 and 9 months post randomisation) 4. Self-reported use of community facilities for physical activity (at 3 and 9 months post randomisation) 5. Self-reported health and social care contacts (at 3 and 9 months post randomisation) 6. Psychological measures of motivation, intentions, attitudes, beliefs, social influences and self-efficacy towards physical activity, measured using the Theory of Planned Behaviour. Exercise stages of change, and self-determination will be assessed using Behavioural Regulation in Exercise Questionnaire (BREQ-2) (at 3 and 9 months post randomisation) |
| Overall study start date | 01/04/2009 |
| Overall study end date | 31/03/2013 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 600 |
| Participant inclusion criteria | 1. Residents of the 20 most deprived neighbourhoods in the city of Sheffield 2. Both males and females, aged 40 to 64 years 3. Not achieving the current recommended activity level (30 mins of moderate activity on at least 5 days) assessed using the Scottish Physical Activity Questionnaire (SPAQ) and wishing to have support to become more active |
| Participant exclusion criteria | 1. 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 2. Capacity to give written informed consent to trial participation |
| Recruitment start date | 01/04/2009 |
| Recruitment end date | 31/03/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
S1 4DA
United Kingdom
Sponsor information
University/education
Research Office
New Spring House
231 Glossop Road
Sheffield
S10 2GW
England
United Kingdom
| Phone | +44 (0)114 222 1469 |
|---|---|
| r.j.hudson@sheffield.ac.uk | |
| Website | http://www.shef.ac.uk |
"ROR" |
https://ror.org/05krs5044 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 04/01/2010 | Yes | No | |
| Results article | results | 01/02/2014 | Yes | No | |
| Results article | results | 24/02/2016 | Yes | No |
Editorial Notes
11/05/2016: Plain English summary added.
26/02/2016: Publication reference added.
