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| Sponsor: | University of Sheffield |
|---|---|
| Collaborator: |
NHS Health Technology Assessment Programme |
| Information provided by: | University of Sheffield |
| ClinicalTrials.gov Identifier: | NCT00836459 |
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. |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
| 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 | |
| Principal Investigator: | Liddy Goyder, MD FFPH | University of Sheffield |
More Information
| 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 |
|
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 |