Condition category
Not Applicable
Date applied
12/02/2009
Date assigned
16/02/2009
Last edited
11/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Elizabeth Goyder

ORCID ID

Contact details

University of Sheffield
Regent Court
30 Regent St
Sheffield
S1 4DA
United Kingdom
-
e.goyder@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00836459

Protocol/serial number

HTA 07/25/02; 120243

Study information

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

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

North Sheffield Local Research Ethics Committee, approval pending as of 12/02/2009

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

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/04/2009

Overall trial end date

31/03/2013

Reason abandoned

Eligibility

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 type

Other

Age group

Adult

Gender

Both

Target number of participants

600

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

United Kingdom

Trial participating centre

University of Sheffield
Sheffield
S1 4DA
United Kingdom

Sponsor information

Organisation

University of Sheffield (UK)

Sponsor details

Research Office
New Spring House
231 Glossop Road
Sheffield
S10 2GW
United Kingdom
+44 (0)114 222 1469
r.j.hudson@sheffield.ac.uk

Sponsor type

University/education

Website

http://www.shef.ac.uk

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20047672
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24571932
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26908117

Publication citations

  1. Protocol

    Hind 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, 10, 3, doi: 10.1186/1471-2458-10-3.

  2. Results

    Goyder 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, 18, 13, 1-210, doi: 10.3310/hta18130.

  3. Results

    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 , 17, 1, 104, doi: 10.1186/s13063-016-1229-0.

Additional files

Editorial Notes

11/05/2016: Plain English summary added. 26/02/2016: Publication reference added.