An interventional study of Physical activity referral scheme and Usual care exercise referral scheme in Cardiovascular Risk Factor, Diabetes Mellitus, Type 2 and Anxiety, sponsored by Paula Watson. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-30.
Sponsored by Paula Watson · Not applicable, Interventional, and Prevention
Among 570 studies in Diabetes Mellitus, Type 2 with a site in United Kingdom — 55 open to participants now, 71 under way, 18 of them phase 3. Diabetes Mellitus, Type 2 · United Kingdom.
Among the 570 studies in Diabetes Mellitus, Type 2 with a site in United Kingdom, this one is the 324th largest by enrollment of the 493 interventional ones that give a count, is one of 27 that started in 2018, is one of 155 with no phase, and was the 392nd registered.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →55 of the 570 studies in Diabetes Mellitus, Type 2 with a site in United Kingdom are open now. Recruiting first, the newest first:
Imperial College London · Sites in United Kingdom
Ascletis Pharma (China) Co., Limited · Sites in United Kingdom, United States, Czechia and 3 more countries
AstraZeneca · Sites in United Kingdom, United States, Argentina and 8 more countries
Novo Nordisk A/S · Sites in United Kingdom, United States, Argentina and 13 more countries
AstraZeneca · Sites in United Kingdom, United States, Argentina and 13 more countries
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
570 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 39 · Phase 2 59 · Phase 3 185 · Phase 4 58
First in 1997; this study’s year is marked. 27 started in 2018.
This study's enrollment of 68 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 200 across the 493 interventional studies, 593 across the 77 observational. Of the 462 that completed or were terminated, 194 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
343 of 570 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Paula Watson as lead sponsor.
Paula Watson has 1 study filed under Diabetes Mellitus, Type 2 — fewer than ten, so there is no comparison to draw.
16 of the studies in Diabetes Mellitus, Type 2 with a site in United Kingdom that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06858878Phase 3AmgenEfficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight | 2027-01-21 |
| NCT07220759Phase 3Novo Nordisk A/SWeight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide | 2027-05-12 |
| NCT07400653Phase 3PfizerA Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D) | 2027-10-12 |
| NCT03811561Phase 3Novo Nordisk A/SA Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes | 2027-11-07 |
| NCT06652763University of LeicesterManganese-enhanced Magnetic Resonance Imaging (MEMRI) in Heart Failure With Preserved Ejection Fraction | 2026-11 |
Among the 570 studies in Diabetes Mellitus, Type 2 with a site in United Kingdom, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The study will evaluate the effectiveness of a co-developed exercise referral scheme. Participants will be recruited to one of three groups 1. Co-developed exercise referral scheme, 2. Usual care exercise referral scheme, 3. No treatment control (no intervention). The study will measure effectiveness by observing change in cardiorespiratory fitness at 12 weeks. Intervention cost-effectiveness will also be evaluated at 3 months follow-up using objective physical activity data.
Evidence of effectiveness for UK exercise referral is unclear. This representation has been deemed an unfair assessment of its potential to impact public health. This is due to systematic review evidence that reports evaluations of exercise referral interventions that are not evidence-based or underpinned by behaviour change theory.
This evaluation is the third phase of a project that aims to co-develop (Phase 1), pilot (phase 2) and evaluate (phase 3) an evidence-based exercise referral scheme. This approach is underpinned by the Medical Research Council guidance for complex interventions.
Through co-development work with a multidisciplinary group of researchers and local stakeholders and subsequent pilot work, it is hypothesised that the co-developed, evidence-based intervention will have improved chances of implementation success, and therefore, clinical effectiveness.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
A physical activity referral scheme co-developed by multidisciplinary stakeholders to incorporate behaviour change support and ensure pragmatic relevance and feasibility.
Behavioral: Physical activity referral scheme
Comparative, usual care exercise referral scheme.
Behavioral: Usual care exercise referral scheme
Lifestyle advice leaflet only (provided to participants in all arms during baseline assessments).
An 18-week physical activity referral scheme co-developed by a local multidisciplinary stakeholder group. Behaviour change support underpinned by Self-Determination Theory (Ryan \& Deci, 2000) will be provided by an exercise referral practitioner at weeks 1,4,8,12 and 18 to facilitate increased physical activity levels. Patients will be supported to develop a tailored programme of physical activity that may involve use of the fitness centre facilities (e.g. swimming, group classes, gymnasium use), participation in community-based initiatives, and changes to habitual physical activity. Focus on promoting patient autonomy and tailoring activities to patient's preferences and needs. Subsidised access to fitness centre facilities for first 12 weeks.
A comparative usual care exercise referral scheme that includes fitness centre based activities (e.g. swimming, group classes, gymnasium use). Patients meet an exercise referral practitioner at their induction (week 1) and week 12 (post scheme). Patients are typically prescribed a gym-based, 12-week programme. Subsidised access to fitness centre facilities for 12 weeks.
Change in cardiorespiratory fitness
Estimated via the Astrand-Rhyming cycle protocol using the updated age and sex specific nomogram.
Time frame: Baseline and week 12.
Change in objective physical activity levels
Objective physical activity levels will be analysed using a hip worn accelerometer (ActiGraph GT3X). 7-day monitoring periods will recorded at three time points. During the 7-day monitoring period, each participant will complete a diary to record hours of use and to distinguish between work and leisure hours.
Time frame: Baseline, week 12, and 6 months
Change in flow-mediated dilation
Endothelium dependent vasodilatation of the brachial arteries will be examined using ultrasound. Brachial artery baseline diameter and blood flow will be assessed in one arm. An ultrasound probe is placed on the bicep for 1 minute before a blood pressure cuff (placed around the forearm) is inflated to suprasystolic pressure (\~220 mmHg) for 5 minutes. Immediately after the cuff is deflated, changes in arterial diameter and flow will be assessed continuously for 3 minutes using the ultrasound probe. Ultrasound data will then be analysed post hoc.
Time frame: Baseline and week 12.
Change in carotid vasoreactivity
The carotid vasoreactivity (cold pressor) test will measure the carotid artery's response to a stimulus. Similar to the flow-mediated dilation procedure, an ultrasound probe will be placed on the patient's left side of their neck, positioned in such a way to allow a clear image of the right common carotid artery to be displayed on the ultrasound monitor screen. The cold pressor procedure involves submersion of the left hand to wrist in ice slush for 180-seconds. Ultrasound data will then be analysed post hoc.
Time frame: Baseline and week 12.
Change in total cholesterol
A 15ml blood sample will be taken. Blood profiles will be analysed as a measure of cardiometabolic health. Analysis will be conducted at LJMU. Patients will be made aware of the storage and use of their tissue.
Time frame: Baseline and week 12.
Change in plasma glucose
A 15ml blood sample will be taken. Blood profiles will be analysed as a measure of cardiometabolic health. Analysis will be conducted at LJMU. Patients will be made aware of the storage and use of their tissue.
Time frame: Baseline and week 12.
Change in triglycerides
A 15ml blood sample will be taken. Blood profiles will be analysed as a measure of cardiometabolic health. Analysis will be conducted at LJMU. Patients will be made aware of the storage and use of their tissue.
Time frame: Baseline and week 12.
Change in self-reported physical activity
Patients' perceived physical activity levels will be recorded with the short version of the International Physical Activity Questionnaire (IPAQ, Craig et al., 2003). The short-IPAQ is a 7-day recall self-administered tool that measures intensity, frequency and duration of physical activity and provides a total estimate of energy expenditure. A total score of MET-minutes/day/week and sedentary behaviour minutes/day/week will be calculated according to the IPAQ scoring protocol.
Time frame: Baseline, week 12, and 6 months.
Change in psychological wellbeing
Psychological wellbeing will be measured using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS, Tennant et al., 2007). WEMWBS is a 14-item positively worded instrument 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.
Time frame: Baseline, week 12, and 6 months.
Attendance at consultations
Patient attendance records will be collected by ERPs at the following time-points: * Intervention centre: 1, 4,8,12 and 18 weeks; * Usual care centre: 1 and 12 weeks.
Time frame: Week 1, 4, 8, 12, and 18
Attendance at fitness centre
The number of times patients sign in at the fitness centre to go to either the gym or a class will be recorded on a weekly basis for weeks 1 to 12, then on a monthly basis up to 6 months. This information is automatically recorded at fitness centres when patients visit.
Time frame: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12. Months 4, 5 and 6
Fidelity - consultation attendance
ERPs from both intervention and usual care centres will be asked to monitor the number of consultations offered (measured by appointment bookings or records of appointments offered but declined by participants), and the number of consultations conducted for each patient.
Time frame: Week 18
Fidelity - consultation communication strategies
A random sample of ERS inductions from both intervention and usual care centres (approx 10 per centre) plus a random sample of 4, 8, 12 and 18-week consultations from the intervention centre only will be audio-recorded and coded for the use of "needs-supportive" communication strategies (using a coding manual developed through a previous pilot study (REF 16/WA/0231)). In addition, all intervention centre recordings will be coded for fidelity to an agreed protocol, e.g. asking required questions about physical activity, setting an action plan, giving out patient log book etc.
Time frame: Week 1, 4, 8, 12, and 18
Change in health-related quality of life measure
Participants' change in health-related quality of life (HRQoL) will be measured at baseline, 12 weeks, and 6 months. The EQ-5D will be used, this is a validated tool for measuring HRQoL. This tool has been applied successfully in a recent UK trial-based economic evaluation of exercise referral schemes (Edwards et al. 2013).
Time frame: Baseline, week 12, and 6 months.
Intervention operating and set up costs
Captured via telephone interview with Exercise Referral Scheme Personnel from (organisation e.g. local authority/ fitness centre/ research institute; questions adapted from validated questionnaire).
Time frame: Week 18
Loss in revenue costs
Captured via telephone interview with fitness centre manager and/or coordinators (questions have been used in previous research).
Time frame: Week 18
Change in patient costs
Captured via patient questionnaire during lab testing (questions adapted from validated questionnaire).
Time frame: Baseline, Week 12 and 6 months
Change in patient health care utilisation costs
Captured via questionnaire (questions adapted from validated questionnaire).
Time frame: Baseline and 6 months
Change in exercise motivation
The Behavioural Regulation in Exercise Questionnaire (BREQ-2, Markland \& Tobin, 2004) plus 4 additional items (Wilson et al., 2006a) will be used to assess exercise motivation. The BREQ-2 is a widely-used instrument comprised of 19 items describing reasons why people exercise (e.g. "I think exercising is a waste of time"; "I feel ashamed when I miss an exercise session"; "I exercise because it's fun"). Participants answer on a likert scale of 0 (not true for me) to 4 (very true to me) to indicate how true each item is for them.
Time frame: Baseline, week 12, and 6 months.
Change in psychological needs satisfaction
Psychological need satisfaction will be measured using the Psychological Need Satisfaction in Exercise Scale (PNSE, Wilson et al., 2006b). The PNSE is an 18-item instrument designed to measure participants' perceived autonomy (e.g. "I feel free to exercise in my own way"), competence (e.g. "I feel capable of completing exercises that are challenging to me") and relatedness (e.g. "I feel connected to the people who I interact with while we exercise together") in an exercise context. Participants are asked to answer on a 6-point likert scale (1 = false, 6 = true) to indicate how they typically feel when they exercise.
Time frame: Baseline, week 12, and 6 months.
Change in perceived needs support
Needs support will be measured using a 15-item needs support (NS) tool developed by Markland and Tobin (2010) to measure the extent to which participants perceive their exercise instructors provide support for autonomy, structure (linked to competence) and involvement (linked to relatedness).
Time frame: Baseline, week 12, and 6 months.
Change in intentions to engage in physical activity
Three items developed by Edmunds et al. (2007) will be used to assess patients' intentions to engage in PA (e.g. "I plan to regularly engage in PA during the next 3 months").
Time frame: Baseline, week 12, and 6 months.
Patient focus groups - intervention
Focus groups will be conducted with a purposeful subsample of patients after approximately 6-12 weeks of attending the scheme (e.g. those with low attendance, high attendance, significant health changes, no change etc.). Two focus groups will be conducted with patients attending the intervention centre (approx 5-8 participants per group). Focus groups will be conducted at the individual fitness centres and will last approximately 60 minutes. Discussion will focus on the extent to which, and how, patients feel each ERS is facilitative (or not) in helping them become more physically active, with questions about staff interactions, activities on offer, and the impact of the scheme on their likely continuation with physical activity.
Time frame: Week 12
Patient focus groups - usual care
Focus groups will be conducted with a purposeful subsample of patients after approximately 6-12 weeks of attending the scheme (e.g. those with low attendance, high attendance, significant health changes, no change etc.). Two focus groups will be conducted with patients attending the usual care centre (approx 5-8 participants per group). Focus groups will be conducted at the individual fitness centres and will last approximately 60 minutes. Discussion will focus on the extent to which, and how, patients feel each ERS is facilitative (or not) in helping them become more physically active, with questions about staff interactions, activities on offer, and the impact of the scheme on their likely continuation with physical activity.
Time frame: Week 12
Exercise referral practitioner (ERP) interviews (intervention group only)
ERPs from the intervention centre only will take part in a semi-structured interview (after over half of patients have reached the 18-week point). The interviews will aim to explore the acceptability of the co-developed intervention, any challenges of delivery, and areas that require further development etc.
Time frame: Week 18
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2018 to primary completion in Feb 2019, 11 months.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's 11 months is below that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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