| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN88907382 |
| Date ISRCTN assigned | 31/03/2008 |
| Local reference number(s) | N/A |
| Public title | Walking for Wellbeing in the West: a pedometer-based walking programme in combination with a physical activity consultation with a 12-month follow-up |
| Scientific title | The "Walking for Wellbeing in the West" randomised controlled trial of a pedometer-based walking programme in combination with a physical activity consultation with a 12-month follow-up |
| Acronym | WWW |
| Disease/condition/study domain | Promotion of physical activity in the general population |
| Study hypothesis | Walking has been identified as an ideal mode of exercise to promote physical activity in the general population. Large knowledge gaps exist on the optimum methods to promote and sustain walking behaviour in a community setting. Following the RE-AIM principles, WWW is investigating whether a pedometer-based walking programme, in combination with a physical activity consultation will help community dwelling low active adults achieve and sustain the physical activity recommendation of 30 minutes of activity at least 5 days of the week. The study has six key research components (behavioural, psychological, environmental, physiological, qualitative and economic) allowing an insight into the complex relationships between behavioural change, health consequences and the role of the environment, along with participants' views and experiences and the cost effectiveness of this approach.
Research question:
Can a pedometer-based walking programme, in combination with a physical activity consultation increase and maintain walking behaviour over a 12 month period? |
| Design/methodology | Single-centre randomised controlled trial |
| Research ethics review | Ethics approval received from the University of Strathclyde Ethics Committee on the 19th July 2006 (ref: UEC0506/56). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Men and women, aged 18 - 65 years
2. Able to understand the rationale behind the trial
3. Able to walk independently for 5 - 10 minutes
4. Those who speak English
5. Those who are in the precontemplation, contemplation or preparation stages of the transtheoretical model of behaviour change (with respect to meeting the current physical activity recommendations) using an adapted stage of change algorithm |
| Participants - exclusion criteria | Involved in regular activity (i.e., not in stages 1 - 3 of the transtheoretical model of behavioural change). |
| Patient information material |
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| Anticipated start date | 01/07/2007 |
| Anticipated end date | 01/08/2008 |
| Status of trial | Ongoing |
| Target number of participants | 79 |
| Interventions | Participants were randomised into one of two groups: immediate intervention (Group 1) or waiting list control (Group 2).
Participants randomised to Group 1 received a 30 minute physical activity consultation with a trained member of the research team. The participant was given an individualised 12-week walking programme and a pedometer. Following the 12-week walking programme, the participants received a second individual physical activity consultation focusing on relapse prevention. Participants received a written physical activity advice leaflet at 24 weeks and a telephone consultation at 36 weeks.
Participants randomised to Group 2 were allocated to a 12 week waiting list and were requested not to amend their current physical activity levels. After 12 weeks Group 2 received an individualised 12 week walking programme identical to Group 1, brief advice and a pedometer but did not receive a physical activity consultation (i.e., the waiting list control group then became a minimal intervention group).
At 24 weeks and 36 weeks participants received a short feedback session. |
| Primary outcome measure(s) | Walking behaviour: pedometer step counts (Omron HJ-109E Step-O-Meter).
Timepoints of measurement:
Intervention group - at baseline, 3, 6 and 12 months
Control group - at baseline, 3, 6, 9 and 15 months |
| Secondary outcome measure(s) | 1. Walking behaviour: seven-day recall of physical activity using the International Physical Activity Questionnaire (IPAQ) (long version, self-report). This will be assessed at baseline, 3 , 6 and 12 months (intervention) and at baseline, 3, 6, 9 and 15 months (control).
2. Psychological: the four constructs of the Transtheoretical Model (stages of change, processes of change, self efficacy, and decisional balance questionnaires), along with mood (Positive and Negative Affect Schedule [PANAS] questionnaires) and quality of life (European Quality of Life [EQ-5D] questionnaires). This will be assessed at baseline, 12, 24 and 48 weeks (intervention) and at baseline, 12, 24, 36 and 60 weeks (control).
3. Physiological: Body composition, blood pressure, heart rate, total cholesterol, high density lipoprotein (HDL) cholesterol, insulin and glucose, and circulating levels of inflammatory markers. For the intervention group, all physiological measures were taken at baseline and 12 weeks. At 24 weeks body mass, body mass index (BMI), waist-to-hip ratio, percentage body fat, blood pressure and heart rate were assessed. In the control group, all physiological measures were assessed at baseline, 12 week and 24 weeks. At 36 weeks body mass, BMI, waist-to-hip ratio, percentage body fat, blood pressure and heart rate were assessed.
4. Environmental: perceived (subjective) environmental barriers or facilitators to activity, and also any changes in physical activity levels and environmental perceptions over the course of the study using the Neighbourhood Quality of Life Study (1st Survey; NQLS). Questionnaires were completed at baseline, 12 weeks, 24 weeks and 48 weeks (interverntion) and at baseline, 12 weeks, 24 weeks, 36 weeks and 60 weeks (control). An environmental audit tool and geographic information system (GIS) data provides an objective assessment of the study area in relation to walking.
5. Qualitative: a qualitative evaluation is being undertaken alongside the main randomised controlled trial to understand the social context of the trial
6. Economic: A health economist is economically evaluating the trial to give cost-effectiveness in terms of cost/quality-adjusted life years (QALY) gained and the cost per individual achieving the target (30 minutes of exercise on 5 days/week) |
| Trial website | http://ewds.strath.ac.uk/sparcoll/ResearchFramework/Phase2/tabid/1672/Default.aspx |
| Sources of funding | Walking for Well-being in the West is part of work carried out by the Scottish Physical Activity Research Collaboration (SPARColl). SPARColl is managed by NHS Health Scotland, hosted by the University of Strathclyde, Glasgow and funded by the Scottish Government. |
| Sponsor name | University of Strathclyde (UK) |
| Sponsor details | Research and Innovation
50 George Street
Glasgow
United Kingdom
G1 1WQ |
| Sponsor website | http://www.strath.ac.uk/ri |
| Contact name | Prof Nanette Mutrie |
| Contact details | Sport, Culture and Arts
76 Southbrae Drive
Glasgow
United Kingdom
G13 1PP |
| Contact telephone | +44 (0)141 950 3371 |
| Contact fax | +44 (0)141 950 3132 |
| Contact email | nanette.mutrie@strath.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN88907382 |
| Date last extracted from ISRCTN register | 17/04/2008 |
