Sheffield Physical Activity Booster Trial (Booster)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00836459
Recruitment Status : Completed
First Posted : February 4, 2009
Last Update Posted : December 2, 2014
NHS Health Technology Assessment Programme
Information provided by (Responsible Party):
Richard Hudson, University of Sheffield

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Public Health Behavioral: Mini Booster Behavioral: Full Booster Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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.
Study Start Date : November 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Control
Experimental: Mini Booster Behavioral: Mini Booster
Two telephone-based physical activity consultations, delivered in a motivational interviewing style, at one month and two months from randomisation
Experimental: Full Booster Behavioral: Full Booster
Two face-to-face physical activity consultations, delivered in a motivational interviewing style, at one month and two months from randomisation

Primary Outcome Measures :
  1. Physical activity measured by accelerometry. [ Time Frame: 3 months post-randomisation ]

Secondary Outcome Measures :
  1. Physical activity assessed by accelerometry. [ Time Frame: 9 months post-randomisation ]
  2. 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 ]
  3. Health−related quality of life using the Sheffield Version SF−12v2 plus 4 survey instrument [ Time Frame: 3 months and 9 months post-randomisation ]
  4. Self−reported use of community facilities for physical activity [ Time Frame: 3 months and 9 months post-randomisation ]
  5. Self−reported health and social care contacts [ Time Frame: 3 months and 9 months post-randomisation ]
  6. Psychological measures of motivation, assessed using BREQ−2 (Mullan et al, 1997) [ Time Frame: 3 months and 9 months post-randomisation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00836459

United Kingdom
Centre for Sport and Exercise Science, Sheffield Hallam University
Sheffield, South Yorkshire, United Kingdom, S10 2BP
Sponsors and Collaborators
Richard Hudson
NHS Health Technology Assessment Programme
Principal Investigator: Liddy Goyder, MD FFPH University of Sheffield

Publications of Results:
Goyder, Elizabeth, et al.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Richard Hudson, Sponsor, University of Sheffield Identifier: NCT00836459     History of Changes
Other Study ID Numbers: 120243
HTA: 07/25/02
IRAS: 08/H1308/270
First Posted: February 4, 2009    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: December 2014

Keywords provided by Richard Hudson, University of Sheffield:
Middle Aged
Behavior Therapy
Directive Counseling
Health Behavior
Interview, Psychological
Physical Fitness
Self Efficacy
Life Style
Health Promotion
Health Knowledge, Attitudes, Practice
Body Mass Index
Monitoring, Ambulatory