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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


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
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