- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03153098
An Evaluation of the Active Herts Physical Activity Programme
Physical Activity Promotion in Areas of Deprivation for Inactive Adults With Cardiovascular Disease (CVD) Risk: An Evaluation of Active Herts
There is a high prevalence of inactive adults in the United Kingdom (UK), many of whom suffer from conditions such as diabetes, cardiovascular disease, and poor mental health. These problems often co-exist more frequently in areas of higher socio-economic deprivation. There is an ongoing need to test the effectiveness, acceptability, and sustainability of community physical activity interventions. The Active Herts programme is a community physical activity programme aimed at inactive adults aged 16 and over who have one or more risk factors for cardiovascular disease (CVD) and/or a mild to moderate mental health condition. The programme uses the latest evidence-based behaviour change techniques to target physical activity, wellbeing, and key drivers of behaviour from the COM-B ('Capability', 'Opportunity', 'Motivation' and 'Behaviour') model of behaviour change.
This evaluation will follow a mixed-methods longitudinal (baseline, and 3, 6 and 12 month follow-ups) pragmatic observational design. Two types of programme are being delivered, each in a different area. In one, group participants will receive a behaviour change technique booklet, consultations (baseline, and optional at 3, 6, and 12 months), a booster phone call (week 2), motivational text messages (weeks 3, 6, and 12), and signposting to 12 weeks of exercise classes. In the other 'enhanced delivery' group, participants will receive the same but the 12 weeks of exercise will be free and tailored to their needs, and there will be optional exercise 'buddies' available. An outcome evaluation will assess changes in physical activity as the primary outcome, and sporting participation, sitting, wellbeing, psychological capability, and reflective motivation as secondary outcomes. A process evaluation will use both one-to-one interviews and focus groups to explore the views of stakeholders, delivery staff, and participants over three phases (set-up, deviations in the delivery of the intervention, and looking back over the intervention). Economic evaluation will examine the costs of the Active Herts programme against the benefits gained in terms of reduced risk of morbidity from a range of chronic conditions.
This study will measure key drivers of physical activity using up to date behaviour change theory, allowing evaluation of not only whether physical activity has increased but also why. The research will inform the future development of a scalable intervention that can be more robustly tested in a randomised controlled trial.
Study Overview
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Norwich, United Kingdom, NR4 7TJ
- Recruiting
- University of East Anglia
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Contact:
- Andy Jones, Prof
- Phone Number: 0044 1603 593127
- Email: A.P.Jones@uea.ac.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- inactive adults and do less than 30mins of physical activity per week
- aged 16 or over
- resident of Hertfordshire boroughs, including Broxbourne, Hertsmere, Stevenage or Watford
Referred patients and clients may also have:
- a long term medical condition such as type 2 diabetes, hypertension, high cholesterol etc.
- a mild to moderate mental health condition such as anxiety, depression or stress
- a history or family history of heart disease
Exclusion Criteria:
- participants not able to give informed consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Standard delivery
Participants will receive a behaviour change technique booklet, consultations (baseline, and optional at 3, 6, and 12 months), a booster phone call (week 2), motivational text messages (weeks 3, 6, and 12), and signposting to 12 weeks of exercise classes.
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Active Herts is a community physical activity intervention aimed at inactive adults aged 16 and over who have one or more risk factors for CVD and/or a mild to moderate mental health condition.
The programme uses the latest evidence-based behaviour change techniques to target physical activity, wellbeing, and key drivers of behaviour from the COM-B model of behaviour change.
Other Names:
|
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Enhanced delivery
Participants will receive the same as intervention but the 12 weeks of exercise will be free and tailored to their needs, and there will be optional exercise 'buddies' available.
|
Active Herts is a community physical activity intervention aimed at inactive adults aged 16 and over who have one or more risk factors for CVD and/or a mild to moderate mental health condition.
The programme uses the latest evidence-based behaviour change techniques to target physical activity, wellbeing, and key drivers of behaviour from the COM-B model of behaviour change.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Physical activity from baseline
Time Frame: 12 months
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Assessed using the International Physical Activity Questionnaire (IPAQ)
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in mental well-being from baseline
Time Frame: Short term (3 months), longer term (6 and 12 months)
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Assessed using Warwick Edinburgh well-being scale
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Short term (3 months), longer term (6 and 12 months)
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Change in perceptions of health from baseline
Time Frame: Short term (3 months), longer term (6 and 12 months)
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EuroQOL five dimensions questionnaire (EQ-5D)
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Short term (3 months), longer term (6 and 12 months)
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Readiness to change behaviour
Time Frame: Short term (3 months), longer term (6 and 12 months)
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Key determinants of behaviour - measured using COM-B Capability, Opportunity, and Motivation
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Short term (3 months), longer term (6 and 12 months)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Delivery fidelity
Time Frame: End February 2017, Summer 2017, Autumn 2018
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A process evaluation of Active Herts will take place in three phases with each phase exploring a different theme.
Data will be collected in the form of one-to-one interviews with stakeholders, group interviews with the Get Active Specialists, and focus groups with participants.
Stakeholders interviewed will include commissioners, higher intervention management, project delivery partners, and health service practitioners.
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End February 2017, Summer 2017, Autumn 2018
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Programme cost-effectiveness
Time Frame: October 2017 - October 2018
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The economic evaluation will examine the costs of delivery of the Active Herts intervention against the benefits gained in terms of reduced risk of morbidity from a range of chronic conditions, the risk of which is associated with physical inactivity.
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October 2017 - October 2018
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Andy Jones, Prof, University of East Anglia
Publications and helpful links
General Publications
- Chater AM, Schulz J, Jones A, Burke A, Carr S, Kukucska D, Troop N, Trivedi D, Howlett N. Outcome evaluation of Active Herts: A community-based physical activity programme for inactive adults at risk of cardiovascular disease and/or low mental wellbeing. Front Public Health. 2022 Sep 9;10:903109. doi: 10.3389/fpubh.2022.903109. eCollection 2022.
- Howlett N, Jones A, Bain L, Chater A. How effective is community physical activity promotion in areas of deprivation for inactive adults with cardiovascular disease risk and/or mental health concerns? Study protocol for a pragmatic observational evaluation of the 'Active Herts' physical activity programme. BMJ Open. 2017 Nov 25;7(11):e017783. doi: 10.1136/bmjopen-2017-017783.
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ActiveHerts
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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