Sheffield Physical Activity Booster Trial

NCT ID: NCT00836459

Last Updated: 2014-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 282 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2013-12-31

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.

Conditions

Public Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Mini Booster

Group Type: EXPERIMENTAL

Mini Booster

Intervention Type: BEHAVIORAL

Two telephone-based physical activity consultations, delivered in a motivational interviewing style, at one month and two months from randomisation

Full Booster

Group Type: EXPERIMENTAL

Full Booster

Intervention Type: BEHAVIORAL

Two face-to-face physical activity consultations, delivered in a motivational interviewing style, at one month and two months from randomisation

Interventions

Mini Booster

Two telephone-based physical activity consultations, delivered in a motivational interviewing style, at one month and two months from randomisation

Intervention Type: BEHAVIORAL

Full Booster

Two face-to-face physical activity consultations, delivered in a motivational interviewing style, at one month and two months from randomisation

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NHS Health Technology Assessment Programme

OTHER

Sponsor Role: collaborator

Richard Hudson

OTHER

Sponsor Role: lead

Responsible Party

Richard Hudson

Sponsor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Liddy Goyder, MD FFPH

Role: PRINCIPAL_INVESTIGATOR

University of Sheffield

Locations

Centre for Sport and Exercise Science, Sheffield Hallam University

Sheffield, South Yorkshire, United Kingdom

Countries

United Kingdom

References

Goyder, Elizabeth, et al.

Reference Type: RESULT

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.

Reference Type: DERIVED

PMID: 26908117 (View on PubMed)

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 Feb;18(13):1-210. doi: 10.3310/hta18130.

Reference Type: DERIVED

PMID: 24571932 (View on PubMed)

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 Jan 4;10:3. doi: 10.1186/1471-2458-10-3.

Reference Type: DERIVED

PMID: 20047672 (View on PubMed)

Other Identifiers

HTA: 07/25/02

Identifier Type: -

Identifier Source: secondary_id

IRAS: 08/H1308/270

Identifier Type: -

Identifier Source: secondary_id

120243

Identifier Type: -

Identifier Source: org_study_id