Physical ActivityNCT02142478
Evaluation of Two Different Delivery Approaches of a GP Exercise Referral Scheme
An observational study of Physical Activity, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Physical Activity
- What is being tested?
- Adapted Exercise for Health (EFH) scheme and Standard Exercise for Health (EFH) scheme
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 202 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2014to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Inactive adults (16+ years) who have, or are at risk of developing, a medical condition (e.g. hypertension, obesity, depression).
Who may be able to join
- Individuals attending an EFH induction at centre A or centre B during the recruitment period (anticipated to be between May and July 2014).
Who cannot join
- Participants with an insufficient level of English language to understand the participant information sheet (in written or spoken format).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool John Moores University
Liverpool, Merseyside, L3 2AT
About this study
Official title: Theory-informed Evaluation of Two Delivery Approaches of a GP Exercise Referral Scheme
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:
Read more
- 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.
Read the detailed description
This mixed-method observational study will compare the short- and long-term effectiveness of two different delivery approaches of an exercise referral scheme (Exercise for Health, EFH). As the intervention is already in widespread use randomisation is not feasible, therefore a case control design is adopted to compare the effectiveness of an adapted EFH scheme (delivered at centre A) with the standard EFH scheme (delivered at centre B). Centre B is selected as the comparison centre due to its similarity to centre A on socio-demographic markers (e.g. number of EFH referrals, socioeconomic make-up of local population).
Although the adapted scheme has not drawn overtly from Self-determination Theory (SDT), it is hypothesised that the adapted scheme promotes greater environmental support of SDT-based psychological needs for participants than the standard EFH scheme. Autonomy is promoted through the increased choice offered through daily sessions and the involvement of the patient in their decision whether to take up the scheme, competence is encouraged through the tailoring of classes to the ability of EFH participants and the opportunity to observe similar others, and relatedness is supported through the social assimilation of participants through regular group activities.
It is hypothesised that:
- Both EFH delivery approaches will have beneficial effects on participants' self-reported PA, self-efficacy and psychological well-being post-intervention.
- Participants attending the adapted scheme will perceive greater needs support, greater psychological needs satisfaction and more autonomous motivation during and post-intervention; will have higher adherence to EFH; will have higher leisure centre attendance from post-intervention to 12 months and report higher PA levels at 12 months.
- Perceived needs support will predict psychological needs satisfaction during the intervention; psychological needs satisfaction during the intervention will predict autonomous motivation and psychological well-being post-intervention; post-intervention autonomous motivation will predict PA at 12 months and leisure centre attendance from post-intervention to 12 months.
- Conditions
- Physical Activity
- Being tested
- Adapted Exercise for Health (EFH) scheme, Standard Exercise for Health (EFH) scheme
- Keywords
- physical activity, behaviour change, exercise referral, self-determination theory, mixed-method, evaluation, qualitative
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Exercise for Health (EFH) schemeBehavioural
12-week subsidised exercise programme at local authority-run leisure centres. Each participant receives a programme of activities tailored to their needs, based on a standard recommendation of two exercise sessions per week. In February 2012, Centre A introduced some changes to the EFH scheme as follows:
- Pre-scheme meeting with a health trainer to help the patient decide if EFH is for them.
- Participants offered specially tailored group classes (exclusive to EFH participants, e.g. low-impact circuits, Zumba) as well as access to the main gym.
- Opportunities to attend daily.
Although subsidised access to mainstream group classes and swim sessions (i.e. includes all leisure centre members) is also available, this option is not openly advertised on the adapted scheme.
Standard Exercise for Health (EFH) schemeBehavioural
12-week subsidised exercise programme at local authority-run leisure centres. Each participant receives a programme of activities tailored to their needs, based on a standard recommendation of two exercise sessions per week.
The scheme includes exclusive EFH gym sessions (i.e. includes EFH participants only) on two to three days of the week, plus subsidised access to mainstream group classes and swim sessions (i.e. includes all leisure centre members).
| Study group | Role | What they receive |
|---|---|---|
| Adapted scheme | Participants referred by their GP practices to Centre A will take part in the Adapted Exercise for Health (EFH) scheme. Receives: Behavioral: Adapted Exercise for Health (EFH) scheme | |
| Standard scheme | Participants referred by their GP practices to Centre B will take part in the Standard Exercise for Health (EFH) scheme. Receives: Behavioral: Standard Exercise for Health (EFH) scheme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 12 weeks, 12 months
Secondary outcomes (4)
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).
Measured: Baseline, 12 weeks, 12 months
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.
Measured: Baseline, 12 weeks, 12 months
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.
Measured: Between baseline and 12 weeks
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).
Measured: Between 12 weeks and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Collaborators
- Brock University
- Responsible party
- Principal investigator, Paula Watson, Liverpool John Moores University
- Investigators
- Paula M Watson, PhD, Principal investigator, Liverpool John Moores University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142478
- Sponsor's protocol ID
- SPS-14-01
- Other IDs
- 14/YH/0160
- Status last verified
- Mar 2016
- First submitted
- 16 May 2014
- Last updated
- 1 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Theory-informed Evaluation of Two Delivery Approaches of a GP Exercise Referral Scheme
- ClinicalTrials.gov ID
- NCT02142478
- Acronym / sponsor ID
- SPS-14-01
- Conditions
- Physical Activity
- Keywords
- physical activity, behaviour change, exercise referral, self-determination theory, mixed-method, evaluation, qualitative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Collaborators
- Brock University
- Study start
- May 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This mixed-method observational study will compare the short- and long-term effectiveness of two different delivery approaches of an exercise referral scheme (Exercise for Health, EFH). As the intervention is already in widespread use randomisation is not feasible, therefore a case control design is adopted to compare the effectiveness of an adapted EFH scheme (delivered at centre A) with the standard EFH scheme (delivered at centre B). Centre B is selected as the comparison centre due to its similarity to centre A on socio-demographic markers (e.g. number of EFH referrals, socioeconomic make-up of local population).
Although the adapted scheme has not drawn overtly from Self-determination Theory (SDT), it is hypothesised that the adapted scheme promotes greater environmental support of SDT-based psychological needs for participants than the standard EFH scheme. Autonomy is promoted through the increased choice offered through daily sessions and the involvement of the patient in their decision whether to take up the scheme, competence is encouraged through the tailoring of classes to the ability of EFH participants and the opportunity to observe similar others, and relatedness is supported through the social assimilation of participants through regular group activities.
It is hypothesised that:
- Both EFH delivery approaches will have beneficial effects on participants' self-reported PA, self-efficacy and psychological well-being post-intervention.
- Participants attending the adapted scheme will perceive greater needs support, greater psychological needs satisfaction and more autonomous motivation during and post-intervention; will have higher adherence to EFH; will have higher leisure centre attendance from post-intervention to 12 months and report higher PA levels at 12 months.
- Perceived needs support will predict psychological needs satisfaction during the intervention; psychological needs satisfaction during the intervention will predict autonomous motivation and psychological well-being post-intervention; post-intervention autonomous motivation will predict PA at 12 months and leisure centre attendance from post-intervention to 12 months.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adapted scheme | – | Behavioral: Adapted Exercise for Health (EFH) schemeParticipants referred by their GP practices to Centre A will take part in the Adapted Exercise for Health (EFH) scheme. |
| Standard scheme | – | Behavioral: Standard Exercise for Health (EFH) schemeParticipants referred by their GP practices to Centre B will take part in the Standard Exercise for Health (EFH) scheme. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inactive adults (16+ years) who have, or are at risk of developing, a medical condition (e.g. hypertension, obesity, depression).
Key inclusion criteria (1 listed)
- Individuals attending an EFH induction at centre A or centre B during the recruitment period (anticipated to be between May and July 2014).
Key exclusion criteria (1 listed)
- Participants with an insufficient level of English language to understand the participant information sheet (in written or spoken format).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted Exercise for Health (EFH) scheme12-week subsidised exercise programme at local authority-run leisure centres. Each participant receives a programme of activities tailored to their needs, based on a standard recommendation of two exercise sessions per week. In February 2012, Centre A introduced some changes to the EFH scheme as follows: * Pre-scheme meeting with a health trainer to help the patient decide if EFH is for them. * Participants offered specially tailored group classes (exclusive to EFH participants, e.g. low-impact circuits, Zumba) as well as access to the main gym. * Opportunities to attend daily. Although subsidised access to mainstream group classes and swim sessions (i.e. includes all leisure centre members) is also available, this option is not openly advertised on the adapted scheme. | Behavioural | Adapted scheme |
| Standard Exercise for Health (EFH) scheme12-week subsidised exercise programme at local authority-run leisure centres. Each participant receives a programme of activities tailored to their needs, based on a standard recommendation of two exercise sessions per week. The scheme includes exclusive EFH gym sessions (i.e. includes EFH participants only) on two to three days of the week, plus subsidised access to mainstream group classes and swim sessions (i.e. includes all leisure centre members). | Behavioural | Standard scheme |
Primary outcome
Change in self-reported physical activity (PA)
Time frame: Baseline, 12 weeks, 12 months
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
4 secondary outcomes
Change in physical activity self-efficacy
Time frame: Baseline, 12 weeks, 12 months
Change in psychological wellbeing
Time frame: Baseline, 12 weeks, 12 months
Adherence to the Exercise for Health programme
Time frame: Between baseline and 12 weeks
Post-intervention leisure centre attendance
Time frame: Between 12 weeks and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula M Watson, PhD principal investigator
Liverpool John Moores University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Activity, run by Liverpool John Moores University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported physical activity (PA) (time frame: Baseline, 12 weeks, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2016.