Primary care patients with a medical condition (i.e., obesity, hypertension, pre-diabetes, type 2 diabetes, osteoarthritis or history of depression) who are suitable for an intervention to increase moderate intensity physical activity Not Applicable
Conditions
Interventions
There is currently no single model for exercise referral schemes in the UK but the predominant mode of delivery, according to a national survey (BHF, 2010) and descriptions provided in peer reviewed a
Sponsors
Plymouth University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 16/09/2016: 1. Aged 16-74 years 2. With one or more of the following: 2.1. Obesity (BMI 30-40) 2.2. Hypertension (Stage 1: SBP 140-159 or DBP 90-99; or Stage 2: SBP 160-179 or DBP 100-109) 2.3. Pre-diabetes 2.4 Type 2 diabetes 2.5. Lower limb osteoarthritis 2.6. Recent history of treatment for depression (i.e., last 2 years) but may not be currently receiving treatment 3. Participants who are in the follow two lowest (of four) groups identified using the GP Physical Activity Questionnaire recommended for use in the physical activity care pathway: 3.1. Inactive sedentary job and no physical exercise or cycling 3.2. Moderately inactive sedentary job and some but < 1 hour physical exercise and/or cycling per week OR standing job and no physical exercise 4. Have an e-mail address and at least some experience of using the internet Previous inclusion criteria: 1. Aged 16-74 years 2. With one or more of the following: 2.1. Obesity (BMI 30-35) 2.2. Hypertension (Stage 1: SBP 140-159 or DBP 90-99; or Stage 2: SBP 160-179 or DBP 100-109) 2.3. Type 2 diabetes 2.4. Lower limb osteoarthritis 2.5. Recent history of treatment for depression (i.e., last 2 years) but may not be currently receiving treatment 3. Participants who are in the follow two lowest (of four) groups identified using the GP Physical Activity Questionnaire recommended for use in the PA Care Pathway: 3.1. Inactive sedentary job and no physical exercise or cycling 3.2. Moderately inactive sedentary job and some but < 1 hour physical exercise and/or cycling per week OR standing job and no physical exercise 4. Have an e-mail address and at least some experience of using the internet
Exclusion criteria
Exclusion criteria: 1. Unstable severe and enduring mental health problem that may limit involvement in the trial 2. Being treated for an alcohol problem or drug addiction 3. Inability to use written materials in English 4. Contra-indicated for moderate intensity PA 5. Have at least one medical condition that would exclude them from referral based on standard operating procedures for the ERS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 11/10/2018: Total weekly minutes of MVPA in >10 minute bouts, recorded objectively by GeneActiv accelerometer, over one week at 12 months. To be included participants need to provide activity recorded on at least 4 days, including a weekend day, for at least 16 hours per day. [This clarification was signed off in the Statistical Analysis Plan for this trial on 21 May 2018.] Previous primary outcome measure as of 16/09/2016: Total weekly minutes of MVPA in >10 minute bouts, recorded objectively by GeneActiv accelerometer, over one week at 12 months Previous primary outcome measures: Objectively assessed PA and the achievement of at least 150 min of MVPA (recorded by GeneActiv accelerometer - http://www.geneactiv.co.uk/ ) over a week, at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 11/10/2018: 1. Achievement of at least 150 minutes of MVPA, measured objectively by accelerometer, over 1 week at 4 months post-randomisation 2. Self-reported achievement of at least 150 minutes of MVPA over one week using the Seven Day Physical Activity Recall Questionnaire at 4 and 12 months post randomisation 3. Self-reported health-related quality of life, assessed by the EQ-5D-5L and SF12v2 at 4 and 12 months post randomisation 4. Self-reported symptoms of anxiety and depression, assessed by the Hospital Anxiety and Depression Scale (HADS) at 4 and 12 months post randomisation 5. Average daily hours/minutes of sleep and sedentary behaviour (objectively measured by accelerometer) over 1 week at 4 and 12 months post randomisation 6. Uptake of the ERS according to the attendance records held by the ERS service provider, with imputed patient-reported attendance at 4 weeks and/or 4 months where the ERS service data are missing. [A convention for analysing participants’ uptake of the ERS was agreed and signed off in the Statistical Analysis Plan for this trial on 27 Sept 2018.] 7. Adherence to the ERS, using a composite measure to describe the proportion in each arm of the trial that achieved the primary outcome at 4 months and were still doing so at 12 months 8. Process measures, to be described and included in mediation analysis including 1-4 self-reported survey items for each of the following: self-efficacy/confidence to be physically active; importance of being physically active; relatedness (perceived frequency and availability of support); perceived autonomy/control over physically active choices; involvement in self-monitoring and planning PA 9. In the intervention group, measures of engagement with e-coachER, and its content, and use of self-monitoring and goal-setting functions, captured by the software platform (LifeGuide) 10. Qualitative interviews with participants in the intervention arm, focusing on their exper | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed