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Sheffield Physical Activity Booster Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Sheffield.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
NHS Health Technology Assessment Programme
Information provided by:
University of Sheffield
ClinicalTrials.gov Identifier:
NCT00836459
First received: February 3, 2009
Last updated: January 11, 2010
Last verified: January 2010
  Purpose

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 Intervention
Public Health
Behavioral: Mini Booster
Behavioral: Full Booster

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by University of Sheffield:

Primary Outcome Measures:
  • Physical activity measured by accelerometry. [ Time Frame: 3 months post-randomisation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical activity assessed by accelerometry. [ Time Frame: 9 months post-randomisation ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Health−related quality of life using the Sheffield Version SF−12v2 plus 4 survey instrument [ Time Frame: 3 months and 9 months post-randomisation ] [ Designated as safety issue: No ]
  • Self−reported use of community facilities for physical activity [ Time Frame: 3 months and 9 months post-randomisation ] [ Designated as safety issue: No ]
  • Self−reported health and social care contacts [ Time Frame: 3 months and 9 months post-randomisation ] [ Designated as safety issue: No ]
  • Psychological measures of motivation, assessed using BREQ−2 (Mullan et al, 1997) [ Time Frame: 3 months and 9 months post-randomisation ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: November 2009
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00836459

Contacts
Contact: Danny Hind, PhD +44 (0)114 222 0707 d.hind@sheffield.ac.uk
Contact: David White +44 (0)114 222 0807 d.a.white@sheffield.ac.uk

Locations
United Kingdom
Centre for Sport and Exercise Science, Sheffield Hallam University Recruiting
Sheffield, South Yorkshire, United Kingdom, S10 2BP
Contact: Emma Scott, PhD    +44 (0)114 225 2524    e.scott@shu.ac.uk   
Sponsors and Collaborators
University of Sheffield
NHS Health Technology Assessment Programme
Investigators
Principal Investigator: Liddy Goyder, MD FFPH University of Sheffield
  More Information

No publications provided by University of Sheffield

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Elizabeth Goyder, The University of Sheffield
ClinicalTrials.gov Identifier: NCT00836459     History of Changes
Other Study ID Numbers: 120243, HTA: 07/25/02, IRAS: 08/H1308/270
Study First Received: February 3, 2009
Last Updated: January 11, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Sheffield:
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

ClinicalTrials.gov processed this record on November 25, 2014