Sheffield Physical Activity Booster Trial

Public Health Clinical Trial

— Booster  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00836459
• Other study ID #: 120243
• Secondary ID: HTA: 07/25/02IRA
• Status: Completed
• Phase: N/A
• First received: February 3, 2009
• Last updated: December 1, 2014
• Start date: November 2009
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: University of Sheffield
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Public Health

Intervention

Behavioral:
• Mini Booster
Two telephone-based physical activity consultations, delivered in a motivational interviewing style, at one month and two months from randomisation
• Full Booster
Two face-to-face physical activity consultations, delivered in a motivational interviewing style, at one month and two months from randomisation

Locations

Country	Name	City	State
United Kingdom	Centre for Sport and Exercise Science, Sheffield Hallam University	Sheffield	South Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Richard Hudson	NHS Health Technology Assessment Programme

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Goyder, Elizabeth, et al.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity measured by accelerometry.		3 months post-randomisation	No
Secondary	Physical activity assessed by accelerometry.		9 months post-randomisation	No
Secondary	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		3 months and 9 months post-randomisation	No
Secondary	Health-related quality of life using the Sheffield Version SF-12v2 plus 4 survey instrument		3 months and 9 months post-randomisation	No
Secondary	Self-reported use of community facilities for physical activity		3 months and 9 months post-randomisation	No
Secondary	Self-reported health and social care contacts		3 months and 9 months post-randomisation	No
Secondary	Psychological measures of motivation, assessed using BREQ-2 (Mullan et al, 1997)		3 months and 9 months post-randomisation	No

External Links

•   Link to abstract and full study report