Physical Activity Clinical Trial
Official title:
Theory-informed Evaluation of Two Delivery Approaches of a GP Exercise Referral Scheme
Verified date | March 2016 |
Source | Liverpool John Moores University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Research Ethics Committee |
Study type | Observational |
Physical activity (PA) benefits both physical and psychological health, yet the majority of
UK adults are physically inactive. "Exercise for Health" (EFH) is a General Practitioner
(GP) exercise referral scheme run in Liverpool for people who are inactive with a medical
condition. Patients are referred by their GP practice, where they receive 12 weeks of
subsidised exercise classes at their local leisure or community centre.
In 2012, one of the thirteen EFH centres (Centre A) introduced some changes to try and
improve EFH at their centre. These changes included:
- a pre-scheme meeting with a health trainer, to help the patient decide if EFH is for
them.
- exclusive classes (gym or activities) available daily for EFH participants (compared to
gym only classes two or three times a week in other centres).
This non-randomised study will compare the effectiveness of the adapted EFH (Centre A) with
standard EFH delivery (Centre B). All participants referred to centre A (n=100 approx) or
centre B (n=100 approx) during the study period will be invited to take part. Changes in
self-reported PA, PA self-efficacy and psychological wellbeing will be measured at the end
of EFH (12 weeks) and at 12-month follow-up. A subsample of participants (n=15 from each
centre) will take part in qualitative interviews to explore the factors that contribute to
effectiveness.
A secondary aim is to explore psychological factors contributing to any differences between
the two centres. Self-determination theory suggests that where participants feel they are
offered choice, feel they are competent at exercise, and feel connected to people they
exercise with, they will be more intrinsically motivated and more likely to continue
exercising. Therefore it is hypothesised that participants attending the adapted EFH will be
more motivated and more likely to continue exercising.
Status | Completed |
Enrollment | 202 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: - Individuals attending an EFH induction at centre A or centre B during the recruitment period (anticipated to be between May and July 2014). Exclusion Criteria: - Participants with an insufficient level of English language to understand the participant information sheet (in written or spoken format). |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United Kingdom | Liverpool John Moores University | Liverpool | Merseyside |
Lead Sponsor | Collaborator |
---|---|
Liverpool John Moores University | Brock University |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Self-determination theory variables | Needs support (4 weeks and 12 weeks only) will be measured using a 15-item needs support (NS) tool that assesses participant perceptions of the extent to which their exercise referral instructors provide support for autonomy, structure (linked to competence) and involvement (linked to relatedness). Psychological needs satisfaction will be measured using the Psychological Need Satisfaction in Exercise Scale (PNSE). The PNSE is an 18-item tool designed to measure participants' perceived autonomy, competence and relatedness in an exercise context. Behavioural regulation of exercise will be measured using the revised Behavioural Regulation in Exercise Questionnaire (BREQ-2), which contains 19 items exploring reasons why people exercise. The scale includes items measuring amotivation, external regulation, introjected regulation, identified regulation and intrinsic motivation of exercise behaviour. Four additional items will be included to assess integrated regulation. |
4 weeks, 12 weeks and 12 months | No |
Other | Qualitative interviews | Qualitative interviews with a randomly-selected subsample of participants (15 per centre) will explore the following research questions: What are the facilitators and barriers to exercise adoption for Exercise-for-Health (EFH) participants? How acceptable is EFH to participants and how could it be improved? How well do the processes of referral, induction and EFH activities at each centre support participants' perceived needs for autonomy, competence and relatedness? What factors (EFH and individual) facilitate PA maintenance at 12 months? |
4 weeks and 12 months | No |
Primary | Change in self-reported physical activity (PA) | Self-reported PA will be measured using the vigorous PA, moderate PA and walking items of the short version of the International Physical Activity Questionnaire (IPAQ). The short-IPAQ is a 7-day recall self-administered tool that measures intensity, frequency and duration of PA and provides a total estimate of energy expenditure. A total score of MET-minutes/week will be calculated according to the IPAQ scoring protocol, which is available to download from http://www.ipaq.ki.se/ipaq.htm | Baseline, 12 weeks, 12 months | No |
Secondary | Change in physical activity self-efficacy | A two-item measure of PA self-efficacy (SE) was developed to reflect the intervention aims. Item one measures self-efficacy to adhere to the Exercise for Health programme ("how confident are you that you can attend exercise sessions twice a week?"); item two measures self-efficacy to adhere to a physically active lifestyle in general ("how confident are you that you can be moderately physically active for at least 30 minutes on 5 days of the week?"). Participants are asked to rate their confidence on a scale of 0 (not at all confident) to 10 (extremely confident). | Baseline, 12 weeks, 12 months | No |
Secondary | Change in psychological wellbeing | Psychological wellbeing will be measured using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS). WEMWBS is a 14-item positively worded measure containing items related to psychological functioning (e.g. "I've been thinking clearly") and subjective well-being (e.g. "I've been feeling cheerful"). Participants are asked to rate on a likert scale of 1 (none of the time) to 5 (all of the time) how well each statement describes their experiences over the last two weeks. | Baseline, 12 weeks, 12 months | No |
Secondary | Adherence to the Exercise for Health programme | Adherence will be expressed as a percentage of the recommended twice weekly leisure centre attendance over 12 weeks. | Between baseline and 12 weeks | No |
Secondary | Post-intervention leisure centre attendance | The number of occasions participants attend either gym sessions, classes or swim sessions between 12 weeks and 12 months will be obtained from computerised attendance records. Two measures will be taken: the absolute number of attendances (regardless of when these occur) and regularity of attendance (i.e. number of months in which participants attend at least once). | Between 12 weeks and 12 months | No |
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