Evaluation of Two Different Delivery Approaches of a GP Exercise Referral Scheme

NCT ID: NCT02142478

Last Updated: 2016-04-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 202 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-12-31

Brief 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. 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:

1. Both EFH delivery approaches will have beneficial effects on participants' self-reported PA, self-efficacy and psychological well-being post-intervention.

2. 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.

3. 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Adapted scheme

Participants referred by their GP practices to Centre A will take part in the Adapted Exercise for Health (EFH) scheme.

Adapted Exercise for Health (EFH) scheme

Intervention Type: BEHAVIORAL

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 scheme

Participants referred by their GP practices to Centre B will take part in the Standard Exercise for Health (EFH) scheme.

Standard Exercise for Health (EFH) scheme

Intervention Type: BEHAVIORAL

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).

Interventions

Adapted Exercise for Health (EFH) scheme

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.

Intervention Type: BEHAVIORAL

Standard Exercise for Health (EFH) scheme

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brock University

OTHER

Sponsor Role: collaborator

Liverpool John Moores University

OTHER

Sponsor Role: lead

Responsible Party

Paula Watson

Lecturer/Senior Lecturer in Exercise and Health Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paula M Watson, PhD

Role: PRINCIPAL_INVESTIGATOR

Liverpool John Moores University

Locations

Liverpool John Moores University

Liverpool, Merseyside, United Kingdom

Countries

United Kingdom

Other Identifiers

14/YH/0160

Identifier Type: OTHER

Identifier Source: secondary_id

SPS-14-01

Identifier Type: -

Identifier Source: org_study_id