Clinical trial NCT02142478: Evaluation of Two Different Delivery Approaches of a GP Exercise Referral Scheme
Official title: Theory-informed Evaluation of Two Delivery Approaches of a GP Exercise Referral Scheme
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Activity
Keywords: physical activity
behaviour change
exercise referral
self-determination theory
mixed-method
evaluation
qualitative
Lead sponsor: Liverpool John Moores University
Sponsor class: OTHER
Collaborators: name: Brock University
First posted: 2014-05-20
Enrollment: 202
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inactive adults (16+ years) who have, or are at risk of developing, a medical condition (e.g. hypertension, obesity, depression).

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.

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).

Primary outcomes:
measure: Change in self-reported physical activity (PA)
timeFrame: Baseline, 12 weeks, 12 months
Secondary outcomes:
measure: Change in physical activity self-efficacy
timeFrame: Baseline, 12 weeks, 12 months
measure: Change in psychological wellbeing
timeFrame: Baseline, 12 weeks, 12 months
measure: Adherence to the Exercise for Health programme
timeFrame: Between baseline and 12 weeks
measure: Post-intervention leisure centre attendance
timeFrame: Between 12 weeks and 12 months
Other outcomes:
measure: Self-determination theory variables
timeFrame: 4 weeks, 12 weeks and 12 months
measure: Qualitative interviews
timeFrame: 4 weeks and 12 months
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool John Moores University
state: Merseyside
Study officials:
affiliation: Liverpool John Moores University
name: Paula M Watson, PhD
role: PRINCIPAL_INVESTIGATOR
References: